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[REGULATORY APPROVAL

ABSTRACT
FRAMEWORK] [This guidance aims at defining the way the regulatory
information on medicinal, health supplement products(Herbal
,Vitamin & minerals) and Infant milk & their formula are
[Drug Approvals Process ] submitted by applicants electronically and received, validated,
processed]
Author : SSS Process / Avermasoft
Jan 10, 2017 V 2.0

For more Information please visit the JFDA Website: http://www.jfda.jo/

Contact us on Email: info@jfda.jo / Phone Number: 06 5632000


Table of Content
Introduction ........................................................................................................................................... 5

10 New Submission Process ....................................................................................................................... .12

1.1. New Submission Procedure Steps ...................................................................................................10

1.2. Validation Phase I.....................................................................................................................11


1.3. Drug Approval Processes .............................................................................................................12

1.3.1. Validation phase II ............................................................................................................12

1.3.2. Assessment Department ......................................................................................................16

1.3.2.1. Efficacy Assessment .......................................................................................................16

1.3.2.2. Quality Assessment ........................................................................................................17

1.3.2.3. Safety Assessment .........................................................................................................18

1.3.2.4. Lab testing Assessment ...................................................................................................18

1.3.2.5. Bioequivalence Assessment ..............................................................................................19

1.3.2.6. Manufacturing Site and Inspection Assessment ........................................................................20

1.3.3. Product approval ..............................................................................................................21

1.3.4. Pricing ..........................................................................................................................22


1.3.5. Product Licensing .............................................................................................................23

1.4. Appeal Process ........................................................................................................................24


242 Renew Submission Process. ................................................................................................................... 28

3 Variation Submission Process. ...................................................................................................................25


3.1. Notification Variation List ...........................................................................................................25

3.2. Registration Approval Variation List ...............................................................................................27

3.3. Technical Committee Approval Variation List ....................................................................................30


4 Inquiries. ...........................................................................................................................................34

System workflow ....................................................................................................................................35


1.1. Submission Process ...................................................................................................................35

1.2. Validation Phase I & Validation Phase II Process .................................................................................36

1.3. Product Approval & Pricing & Certificate Issuing Process .......................................................................37

1.4. Appeal Process ........................................................................................................................37

Administration .......................................................................................................................................39

1. User Activation ............................................................................................................................39

2. Management ...............................................................................................................................40

.2.1 Room Allocation ...................................................................................................................40

2.2. Registration Check List ...........................................................................................................41

2.3. Variation Check List ..............................................................................................................41

2.4. Appointment Invalidation ........................................................................................................42

2.5. Registration Fees ..................................................................................................................43

2.6. Variation Fees .....................................................................................................................43


2.7. Tasks ................................................................................................................................44

2.8. Application Cancellation .........................................................................................................44


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2.9. Pricing Application Cancellation ................................................................................................45

3. Activity Log ................................................................................................................................45

4. Lookups ....................................................................................................................................46

5. User Management .........................................................................................................................46

6. Products....................................................................................................................................46

7. Applications ...............................................................................................................................46

8. Reports .....................................................................................................................................46

8.1. Application Report ................................................................................................................46


8.2. Appointment Report ..............................................................................................................46

8.3. Organization Users Report .......................................................................................................46

8.4. Public Users Report ...............................................................................................................46

8.5. Tasks Report .......................................................................................................................46

8.6. Pricing Report .....................................................................................................................46

Applications Forms ..................................................................................................................................47

47MEDICINE: Originator ……………………….………………………………………………………………………………………………......................................


Step 1: (Application Type) ......................................................................................................................47

Step 2: (Ingredients) ............................................................................................................................47

Step 3: (ATC Code & Clinical Use) .............................................................................................................47

Step 4: (Product Information ...................................................................................................................48

4.1. General Information .............................................................................................................48


4.2. Packaging Information ..........................................................................................................48

4.3. Stability Study ....................................................................................................................49

4.4. Other Information ...............................................................................................................49

Step 5: (Manufacturers) .........................................................................................................................50


5.1. Active Ingredient(s) Manufacturer .............................................................................................50

5.2. Excipients Manufacturer ........................................................................................................50

5.3. Finished Product Manufacturer ................................................................................................50


5.4. Diluent Manufacturer............................................................................................................51

Step 6: (Scientific Advice) ......................................................................................................................51

2 MEDICINE:Generic application . .................................................................................................................51

Step 1: (Application Type) ......................................................................................................................51


Step 2: (Ingredients) ............................................................................................................................51

Step 3: (ATC Code & Clinical Use) .............................................................................................................52

Step 4: (Product Information ...................................................................................................................52

4.1. General Information .............................................................................................................52

4.2. Packaging Information ..........................................................................................................53

4.3. Stability Study ....................................................................................................................53

4.4. Other Information ...............................................................................................................54


Step 5: (Manufacturers) .........................................................................................................................54

5.1. Active Ingredient(s) Manufacturer .............................................................................................54

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5.2. Excipients Manufacturer ........................................................................................................55

5.3. Finished Product Manufacturer ................................................................................................55

5.4. Diluent Manufacturer............................................................................................................55

Step 6: (Bioequivalence) ........................................................................................................................56

Step 7: (Scientific Advice) ......................................................................................................................57

3 MEDICINE: Herbal Drug. ..........................................................................................................................57

Step 1: (Application Type) ......................................................................................................................57

Step 2: (Ingredients) ............................................................................................................................57


Step 3: (ATC Code & Clinical Use) .............................................................................................................58

Step 4: (Product Information ...................................................................................................................58

4.1. General Information .............................................................................................................58

4.2. Packaging Information ..........................................................................................................59

4.3. Stability Study ....................................................................................................................59

4.4. Other Information ...............................................................................................................60

Step 5: (Manufacturers) .........................................................................................................................60


5.1. Active Ingredient(s) Manufacturer .............................................................................................60

5.2. Excipients Manufacturer ........................................................................................................61

5.3. Finished Product Manufacturer ................................................................................................61

5.4. Diluent Manufacturer............................................................................................................61

Step 6: (Scientific Advice) ......................................................................................................................61


4 MEDICINE: New Drug application. ...............................................................................................................62

Step 1: (Application Type) ......................................................................................................................62

Step 2: (Ingredients) ............................................................................................................................62

Step 3: (ATC Code & Clinical Use) .............................................................................................................62


Step 4: (Product Information ...................................................................................................................63

4.1. General Information .............................................................................................................63

4.2. Packaging Information ..........................................................................................................64


4.3. Stability Study ....................................................................................................................64

4.4. Other Information ...............................................................................................................64

Step 5: (Manufacturers) .........................................................................................................................65

5.1. Active Ingredient(s) Manufacturer .............................................................................................65


5.2. Excipients Manufacturer ........................................................................................................65

5.3. Finished Product Manufacturer ................................................................................................66

5.4. Diluent Manufacturer............................................................................................................66

Step 6: (Bioequivalence) ........................................................................................................................66

Step 7: (Scientific Advice) ......................................................................................................................67

5 MEDICINE: BIOLOGICAL. ..........................................................................................................................68

Step 1: (Application Type) ......................................................................................................................68


Step 2: (Ingredients) ............................................................................................................................68

Step 3: (ATC Code & Clinical Use) .............................................................................................................68

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Step 4: (Product Information ...................................................................................................................69

4.1. General Information .............................................................................................................69

4.2. Packaging Information ..........................................................................................................69

4.3. Stability Study ....................................................................................................................70

4.4. Other Information ...............................................................................................................70

Step 5: (Manufacturers) .........................................................................................................................71

5.1. Active Ingredient(s) Manufacturer .............................................................................................71

5.2. Excipients Manufacturer ........................................................................................................71


5.3. Finished Product Manufacturer ................................................................................................71

5.4. Diluent Manufacturer............................................................................................................71

Step 6: (Scientific Advice) ......................................................................................................................71

6 MEDICINE: Radiopharmaceutical. ...............................................................................................................72

Step 1: (Application Type) ......................................................................................................................72

Step 2: (Ingredients) ............................................................................................................................72

Step 3: (ATC Code & Clinical Use) .............................................................................................................73


Step 4: (Product Information ...................................................................................................................73

4.1. General Information .............................................................................................................73

4.2. Packaging Information ..........................................................................................................74

4.3. Stability Study ....................................................................................................................74

4.4. Other Information ...............................................................................................................75


Step 5: (Manufacturers) .........................................................................................................................75

5.1. Active Ingredient(s) Manufacturer .............................................................................................75

5.2. Excipients Manufacturer ........................................................................................................75

5.3. Finished Product Manufacturer ................................................................................................76


5.4. Diluent Manufacturer............................................................................................................76

Step 6: (Scientific Advice) ......................................................................................................................76

7 Herbal & Vitamins product.......................................................................................................................77


Step 1: (Application Type) ......................................................................................................................77

Step 2: (Ingredients) ............................................................................................................................77

Step 3: (Product Claims) ........................................................................................................................77

Step 4: (Product Information ...................................................................................................................78


4.1. General Information .............................................................................................................78

4.2. Packaging Information ..........................................................................................................78

4.3. Stability Study ....................................................................................................................78

4.4. Other Information ...............................................................................................................79

Step 5: (Manufacturers) .........................................................................................................................80

5.1. Active Ingredient(s) Manufacturer .............................................................................................80

5.2. Excipients Manufacturer ........................................................................................................80


5.3. Finished Product Manufacturer ................................................................................................80

Step6: Classification Letter ....................................................................................................................80

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8 Infant Food & Formula Application. ............................................................................................................81

Step 1: (Application TYPE) .....................................................................................................................81

Step 2: (PRODUCT INFORMATION) .............................................................................................................81

4.1. General Information .............................................................................................................81

4.2. Packaging Information ..........................................................................................................81

4.3. Other Information ...............................................................................................................82

Step 3: (COMPOSITION) .........................................................................................................................82

Step 4: (AVERAGE COMPOSOTION) .............................................................................................................83


Step 5: (RECOMENDED USE) ....................................................................................................................83

Step 6: (MANUFACTURERS) .....................................................................................................................83

Revision Sheet
Change & Review History

Date Author Version Comment


25/07/2016 Lubna Al-Faraieh V 1.0 - Initial Draft
15/09/2016 Lubna Al-Faraieh V 1.1 - Add a new Notes
10/11/2016 Lubna Al-Faraieh V1.2 - Add a new updates
20/11/2016 Lubna Al-Faraieh V1.3 - Add Applications Definitions &
Reference number indications
10/01/2017 Wesal Haqaish V1.4 Final Revision.
10/01/2017 JFDA V2.0 Published Guidance

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Introduction
This guidance aims at defining the way the regulatory information on medicinal, health
supplement products (Herbal, Vitamin & minerals) and Infant milk & their formula are
submitted by applicants electronically and received, validated, processed.

For the applicant to get marketing authorization of their Medicinal Product, Health Supplements
(Herbal , Natural, Vitamin & Minerals products) and Infant Milk & their formula in Jordan, they
must register these products , this process involves filling an online application along with
providing adequate information demonstrating product quality, safety & efficacy for the
conditions prescribed/recommended in the proposed labeling for the product.

Striving for a faster, effective and convenient completion of the process with effective
communication, JFDA developed an "electronic Drug registration Workflow System (e-JDWS)",
the e-JDWS will allow the applicant to submit the on-line applications , track their status, renew
and submit variations of their products.

This guidance document is intended to assist employees with the electronic submission of
applications that covering all types:

 Medicine: Originator drug, New drug, Generic drug, Biological drug, Herbal Drugs, Radiopharmaceutical.

 Health Supplements: Herbal Products, Vitamins& minerals Products.

 Infant Food and Formula:


• Infant Formula.
• Special Formula/ Special Formula for Medical Cases.
• Follow up Formula.
• Complementary Formula – JARS, Biscuits and Rusks, Processed Cereal Based Food.

This document consists of five parts:

 Product New submission process.

 Product Assessment & Approval Processes.

 Renewal Submission & approval Process

 Variations submission & approval process: Notification Variations (NA).

Registration Approval Variations (RA).

Technical Committee Approval Variations (TCA).

 Administrative .

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DEFINITIONS :

New Application types:

Medicines :

Originator drug: is generally a medicinal product that was first authorized worldwide for
marketing for a given active substance on the basis of the documentation of its efficacy, safety
and quality (based upon a complete dossier, clinical & non-clinical) also called the innovator.

New Drug: a medicinal product that is not in the scope of originator drug , as an active
substance(alone or in a combination ) not previously authorized as a medicinal product in Jordan
, or may be a generic drug that developed new dosage form or new salt…..etc

Generic Drug: a medicinal product which has the same qualitative and quantitative composition
in active substances and the same pharmaceutical form as the reference medicinal
product(originator), and whose bioequivalence with the reference medicinal product has been
demonstrated by appropriate bioavailability studies.

Biologic Drug (Biological medicinal product): contain one or more active ingredient either
synthesized or extracted from a biologic system, such as vaccines, blood & blood components,
allergenic, somatic cells, gene therapy, tissues, & recombinant therapeutic proteins. Biologics
can be composed of sugars, proteins, or nucleic acids or complex combinations of these
substances, or may be living entities such as cells and tissues. Biologics are isolated from a
variety of natural sources - human, animal, or microorganism - and may be produced by
biotechnology methods and other cutting-edge technologies.

- Vaccines: is a biological preparation that provides active acquired immunity to a


particular disease. A vaccine typically contains an agent that resembles a disease-causing
micro-organism and is often made from weakened or killed forms of the microbe, its
toxins or one of its surface proteins.

- Blood & blood components: any therapeutic substance prepared from human blood as
plasma proteins prepared under pharmaceutical manufacturing conditions (Fractionated
Plasma Products) such as: immunoglobulins(IG), Albumin , coagulation factors (ex:
Plasmatic factor VIII)

- Allergens: the Injectable allergen extracts are used for both diagnosis and treatment and
are sterile liquids that are manufactured from natural substances (such as molds, pollens,
insects, insect venoms) known to elicit allergic reactions in susceptible individuals.
Injectable allergen extracts for food allergies are used only for diagnostic purposes. Also
available as Sublingual allergen extract tablets used for treatment.

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- Bio similar product (or similar biological medicinal product): is a biological


medicinal product that is similar to the reference product in terms of quality, safety &
efficacy, contains a version of the active substance that is similar, in molecular and
biological terms, to the active substance of the reference product. The posology and
route of administration of the bio similar must be the same as those of the reference
medicinal product.

Herbal drug: a pharmaceutical dosage form contains a plant or plant part or an extract or
mixture of these for medicinal use, may contain vitamins and/or minerals , for pharmaceutical
dosage forms (sublingual tab, injection, eye drops &ointments, sup, ovules) will be considered as
herbal drug regardless of the active substance conc.

Radiopharmaceutical preparation:

- Ready for use radioactive product is a medicinal product in a ready-to-use form


suitable for human use that contains a radionuclide. The radionuclide is integral to the
medicinal application of the preparation, making it appropriate for one or more diagnostic
or therapeutic applications.

- Radionuclide generator a system in which a daughter radionuclide (short half-life) is


separated by elution or by other means from a parent radionuclide (long half-life) and
later used for production of a radiopharmaceutical preparation.

- Non-radioactive component (Kits) for radiopharmaceutical preparation In general a


vial containing the no radionuclide components of a radiopharmaceutical preparation,
usually in the form of a sterilized, validated product to which the appropriate radionuclide
is added or in which the appropriate radionuclide is diluted before medical use. In most
cases the kit is a multidose vial and production of the radiopharmaceutical preparation
may require additional steps such as boiling, heating, filtration and buffering.

Health Supplements:

Herbal product: a pharmaceutical dosage form contains a plant or plant part or an extract or
mixture of these, used as supplements to improve health and well-being, and may be used for
other therapeutic purposes without any medical claims.

Vitamin & minerals product: a pharmaceutical dosage form contains Vitamins, minerals used
to supplement a diet and to maintain, enhance and improve the health function of human body. It
is presented in small unit dosage forms (to be administered) such as capsules, tablets, powder,
liquids and shall not include any sterile preparations (i.e. injectable, eye drops).

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Infant milk & special formula:

- Complementary formula (processed cereal based food )(biscuits and rusks )(jar) .

- Special formula /Special formula for medical use.

- Follow up formula.

- Infant formula.

New Active Substance (NAS): A chemical, biological or radiopharmaceutical substance not


previously authorized as a medicinal product.

The term NAS also includes: an isomer, mixture of isomers, a complex or derivative or salt of a
chemical substance previously authorized as a medicinal product but differing in properties with
regard to safety and efficacy from that substance previously authorized; a biological substance
previously authorized as a medicinal product, but differing in molecular structure, nature of
source material or manufacturing process; a radiopharmaceutical substance that is a
radionuclide or a ligand not previously authorized as a medicinal product.

New Chemical Entity (NCE): An active moiety that has not been registered in any
pharmaceutical product, not previously authorized for marketing for any pharmaceutical use in
the country.

Line extension: When a medicinal product has been granted an initial marketing authorization
any additional strengths, pharmaceutical forms, administration routes, presentations, as well as
any extensions shall also be granted an authorization. All these marketing authorizations shall be
considered as belonging to the same global marketing authorization.

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Applications Reference Number Indicators:

Originator Drug ORD Biological Drug BLD

Originator Vitamin Drug ORV Biological Vaccine BLV

Originator Narcotics ORN Biological Blood Product BLB

Generic Drug BGD Biological Allergen BLA

Generic Vitamin Drug BGV Biological Bio-similar BLS

Generic Narcotics BGN Herbal Product HRP

New Drug NDD Vitamin Product VTP

New Vitamin Drug NVD Infant Formula IFF

New Narcotics NND Follow up Formula IFU

Radiopharmaceutical Ready- RRP Special Formula SFF


for-use Radioactive Product

Radiopharmaceutical RRG Special Formula for Medical Cases SFM


Radionuclide Generators

Radiopharmaceutical Non- RNR Complementary Formula Processed CFC


Radioactive Components (kits) Cereal Based Food

Herbal Drug HRD Complementary Formula Biscuits CFB


& Rusks

Complementary Formula Jars CFJ

Application reference number will be generated by the system:

* 00000 after the symbol are: Serial Number for every type of applications.

* The first 000 are: Number of renew times for specific application.

* The second 000 are: Number of Variations for specific application.

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1. New Submission Process

The process of submitting a new drug application to the JFDA consists of three major steps:

1. Online submission of the APPLICATION FORM


2. A hard and a soft-copy of the PRODUCT FILE delivered in person.
3. Drug samples.

 Notes:
 The Hard & Soft Copy (paper submission) shall follow the Common Technical Document (CTD)
format(for medicine applications ).
 All days mentioned throughout this document are Calendar days.

1.1. New Submission Procedure Steps

Applicant will:
1. Go to the JFDA website.
2. Login to apply (each applicant should have a user ID and a password).
3. Choose and complete the appropriate application form: The application form can be saved partially
as the applicant may complete it in several steps (draft applications).
4. Submit the application form and book an appointment to deliver the hard and soft copy of the
product file.
 The earliest appointment can be scheduled 1 to 12 weeks in advance.
 The applicant can reschedule a week before the appointment.
 An automatic reminder will be send 2 days before the appointment.
 A reference number will be generated, and this number should always be used with regard to any
communication with the JFDA.

5. At the appointment, the applicant will deliver the product file (hard and soft copy) along with the
samples.

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1.2. Validation Phase I

- The Drug Registration staff (Screeners) will validate (Phase I) the following:

a. The application form

b. The product files (hard and soft copy)

c. The samples

 The screener can start the screening at the appointment time only, but have the option to view
the application report by using the view report button at any time.
 If the above (Phase I) are validated, the drug application will proceed to the validation phase II
as shown in the figure (1).
 If some of the above are missing or not satisfactory, a deficiency letter will be generated and
given to the applicant stating the deficiencies. The applicant will have a period of 30 days to
complete the requirements and the drug application will not be queued. Otherwise, JFDA will
securely dispose of the product file or extend the product file for another 30 days by RA
Manager Approval.
 If the applicant did not attend for an appointment; the screener can cancel the application after
30 minutes from appointment time by using No Show button.

Figure (1): Screening Step

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1.3. Drug Approval Processes

1.3.1. Validation phase II

- Drug Approval Processes will be subject to the following processes:

A. Validation (Phase II):

- The responsible person of validation phase II is the first reviewer.


- The first reviewer can see all the completed applications from the validation phase I by using:

Homepage Tasks Review Pool Move to Inbox

-The first reviewer can move any application to the application inbox by click on move to inbox button.

 Notes:
- If the application has an approved priority request by the priority committee; the first reviewer can
-Figure- move the application to application inbox by using:

Homepage Tasks Review Pool Priority Move to Inbox


application

- If the priority committee doesn’t accepted the priority request; the first reviewer can cancel the
priority by using:

Homepage Tasks Review Pool Priority Cancel Priority


application

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Figure (2) – Review Pool

- Open Button as shown in the figure (3) used to:


1- View The Application by using view application link as shown in the figure (4).
2- Edit the application as shown in the figure (4).
3- Dispatch the application to the assessment departments.

Figure (3) – Application Inbox

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Figure (4) – View and Edit application link

Validation Phase II:

- The product file will be validated to ensure that all information provided are according to the
requirements and/or guidelines:
a. the completed file will proceed to the next step – assessment.
b. If any information is missing or incorrect, the applicant will be notified electronically by the inquiry.
- The applicant will be given an opportunity to complete the file within inquiry due date. Otherwise, the
file will be rejected.

- First reviewer can assign the application for assessment department and can select the assignee from
the drop list that filtered upon the role by using Add Task Assignment button as shown in the figure (5).

-First Reviewer can select the due date for every task assigned to the assessment department as shown
in the figure (6).

- The first reviewer can cancel the opened assignment tasks by using cancel button as shown in the
figure (5).

- The first reviewer can reopen the closed assignment tasks by using reopen button as shown in the
figure (5).

 Note: the performance target for all assessment department is calculated depends on task due
date that specified from the JFDA Rules.

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Figure (5) – Add Assignment Task

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Figure (6) – Select Assignee and Due date

1.3.2. Assessment Department

1.3.2.1. Efficacy Assessment

- The Efficacy Assessment will be performed by an efficacy group. Once completed an assessment report
will be forwarded to the first reviewer as shown in the figure (7)

-If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through the RA
manager. The response from applicant should be received before the inquiry due date. Otherwise, the inquiry
response will be rejected as shown in the figure (17).

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Figure (7) – Efficacy Department

1.3.2.2. Quality Assessment

- The quality Assessment will be performed by a quality group (validation, technical file, analytical). Once
completed a report will be forwarded to the first reviewer as shown in the figure (8) .

-If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through the RA
manager. The response from applicant should be received before the inquiry due date. Otherwise, the inquiry
response will be rejected as shown in the figure (17).

Figure (8) – Quality Department

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1.3.2.3. Safety Assessment

- The safety Assessment will be performed by a safety group (Clinical Study, PSUR/RMP). Once completed
a report will be forwarded to the first reviewer as shown in the figure (9).

-If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through the RA
manager. The response from applicant should be received before the inquiry due date. Otherwise, the inquiry
response will be rejected as shown in the figure (17).

Figure (9) – Safety Department

1.3.2.4. Lab testing Assessment

- The lab testing Assessment will be performed by a lab testing group. Once completed a report will
be forwarded to the first reviewer as shown in the figure (10).
- If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through
the RA manager. The response from applicant should be received before the inquiry due date.
Otherwise, the inquiry response will be rejected as shown in the figure (17).
- The results will be written in a report and forwarded to the first reviewer.

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Figure (10) – Lab Testing Department

1.3.2.5. Bioequivalence Assessment

- The Bioequivalence Assessment will be performed by a bioequivalence group. Once completed a report
will be forwarded to the first reviewer as shown in the figure (11).

-If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through the RA
manager. The response from applicant should be received before the inquiry due date Otherwise, the inquiry
response will be rejected as shown in the figure (17).

Figure (11) – Bioequivalence Department

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1.3.2.6. Manufacturing Site and Inspection Assessment

- Site Master File (SMF) will be forwarded by the first reviewer to the manufacturing site unit as
shown in the figure (12).

- If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant


through the RA manager. The response from applicant should be received before the inquiry due
date , Otherwise, the inquiry response will be rejected as shown in the figure (17).

- Manufacturing site unit will check if the manufacturing site and line is approved before or not.
1- If the manufacturing line is approved (valid certificate from JFDA), the line would not be
inspected and the secretary of manufacturing site unit will inform the first reviewer.
2- If the manufacturing line is not approved:
a- The secretary of manufacturing site committee send the application to the head of the
inspection unit to schedule a visit for inspection (depending on the time available for both
inspectors and the company).
b- After the visit, the inspection report will be written and forwarded to the Head of inspection
unit.
c- Head of inspection unit will send the inspection report to the secretary of manufacturing site
committee to arrange a new meeting for manufacturing site committee.
d- The final inspection report will be forwarded to the first reviewer.

Figure (12) – Manufacturing Site & Inspection Department

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1.3.3. Product approval

-The secretary of the registration committee will receive all reports from the first reviewer (Efficacy,
Quality, Safety, BE and testing in addition to other requirements: GMP inspection report, company
registration …. Etc.) And forward them to the “Registration Committee” as shown in the figure (13).

- If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through
the RA manager. The response from applicant should be received before the inquiry due date.
Otherwise, the inquiry response will be rejected as shown in the figure (17).

- The secretary of the registration committee assign the application to the registration committee
members.

- The first reviewer will present the final findings.

- The registration committee will either recommend approval with pricing, approval without pricing or
rejection.

- If the registration committee decision is approval without pricing; the meeting minutes are sent to the
licensing department member to issue the certificate (LF1).

- If the registration committee decision is approval with pricing; the meeting minutes are sent to the
pricing head then will be forwarded to the pricing members.

Figure (13) – Registration Committee Tasks

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1.3.4. Pricing

-The head of pricing will receive all product files from the secretary of registration committee and forward
them to the “Pricing members”. Once completed a report will be forwarded to the pricing head as shown
in the figure (14).

- If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through the
RA manager. The response from applicant should be received before the inquiry due date , Otherwise, the
inquiry response will be rejected as shown in the figure (17).

- The Pricing unit will decide the prices according to the J FDA's pricing rules.
- The final price will be written in a report and forwarded to:
a- If the prices match the suggested price from the applicant the prices report forward to the certificate
department to issue the LF1 certificate.
b- If the prices didn’t match the suggested price from the applicant the prices report forward to the
certificate department to issue the LF2 certificate then the certificate department forward this certificate to
the applicant for approval within 90 days or appeal within 30 days from certificate issuing date.

Figure (14) – Pricing Head Tasks

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1.3.5. Product Licensing

- The certificate issuing member will receive all approved product files from:
1- The pricing head to prepare the LF1, LF2, Renew or variation certificates.
2- The secretary of registration committee to prepare the LF1 certificates.

- The certificate issuing member downloads a certificate from the system to be signed by the
directors and then re-loaded into the system as shown in the figure (16).

- The certificate issuing member will send LF2 to the applicant and wait for approval from the
applicant by pricing head.

Figure (16) – Prepare Certificate Tasks

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1.4. Appeal Process

- The applicant has the right to appeal within 30 days of the:

3- JFDA’s Rejection decision (Registration Appeal).

4- Issuing LF2 certificate that contains the prices didn’t match the expected prices (Pricing
Appeal).
fxgfg
- When the applicant make a registration appeal the request received by the registration appeal
committee and the applicant should provide the JFDA by the physical documents and the fees
within 30 days of appeal date, otherwise the appeal request will be rejected.

- If the registration appeal committee accepted the appeal request it will be forwarded to the first
reviewer to complete the cycle.

- When the applicant make a pricing appeal the request received by the pricing head then
forwarded to the pricing member to make a new pricing process then the result forwarded by
the pricing head to the pricing appeal committee to make a decision and the applicant should
provide the JFDA by the physical documents and the fees within 30 days of appeal date,
otherwise the appeal request will be rejected.

a- If the Pricing appeal committee approved the appeal the decision will be forwarded to the
applicant by (New price or Approved the appeal price) then wait a response from the
applicant.

2. Renew Submission Process.

- The renewal of registered products should be carried out every 5 years.


- The applicant can make a renewal process just for registered products.
- The process of submitting a renew drug application to the JFDA consists of two major steps:
1. Online submission of the APPLICATION FORM
2. A hard and a soft-copy of the PRODUCT FILE delivered in person.

 Notes:

 The Renew Process the same of new process.


 The Hard & Soft Copy (paper submission) shall follow the Common Technical Document (CTD)
format.
 All days mentioned throughout this document are Calendar days.

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3.Variation Submission Process

- The Applicant can make the variations just on the registered products and cannot make another
variation unless the first one is finished by approval or rejection.
- The Variations of the registered products are divided into three types :
1- Notification Variation (Type I): In this type, the applicant can make the proposed
change(s) and notify the JFDA simultaneously every Monday. The applicant should
receive a response from the JFDA within 30 days.
2- Registration Approval & Technical Committee Approval Variations (Type II & Type III):
In these types, the applicant make the changes and provide the JFDA with the physical
documents then proceed to the assessment department then to product approval
department to approved the changes.

- Variation Approval:
1- For type I (Notifiable change):
a- The Screener will approve the letter.
b- Notify the applicant.

2- For type II & type III:


a- First Reviewer will receive all the completed applications from the screeners and
forward them to Deputy of RA Manager.
b- Deputy of RA Manager approved the completed files or forward the deficiencies files
to the RA Manager.
c- The RA manager will communicate with the applicant to bring the deficiencies then
forward the application to the Drug Manager.
d- The Drug Manager will either recommend approval, rejection or ask for further
information-if needed.

3.1. Notification Variation List

1. Changes Specific For Solid(Modified Release, Immediate Release) Liquids &


Semisolids Dosage forms
1.1 Formulation Changes
1.1.1. Immediate Release Solid Dosage Forms
Deletion or partial deletion of an ingredient intended to affect the color, taste or fragrance of the product or
change in the ingredient of the printing ink to another approved ingredient
1.1.2. Modified release Solid Dosage Forms
1.1.2.1. Modified release- Non-release Controlling Excipient
Deletion or partial deletion of an ingredient intended to affect the color, taste or fragrance of the product or
change in the ingredient of the printing ink to another approved ingredient.

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1.1.3. Non-Sterile Semisolid Dosage Forms (e.g. creams, gels, lotions, & ointments) intended for topical
routes of administration
1.1.3.1. Components and Composition
Deletion or partial deletion of color, Fragrance or flavor.
1.1.4. Liquid dosage form
Reduction or deletion of one or more components of the coloring /flavoring systems
1.2. Manufacturing Changes
1.2.1. Change in the batch size of the finished product
Up to10-fold compared to the original batch size approved at the grant of the marketing authorization
(Downscaling and Up scaling).
1.3. Packaging (Container/Closure System) changes
1.3.1. Changes that have minimal potential to have adverse effects on the product
Adding or changing child resistant features of the closure.
Change from a metal to plastic screw cap or plastic to metal screw cap while the inner seal remains
unchanged.
Changing from one plastic to another same type of plastic container ( e.g HDPE to another HDPE container).
Change in or addition of a cap liner or a seal.
Increasing the wall thickness of a solid dosage form container
Change in weight of filler( cotton) without changing the type of filler.
Addition of a desiccant.
Changing in size and /or shape of container/ closure containing same number of dose units for non sterile
solid dosage form.
1.3.2. Changes that have moderate potential to have an adverse effect on the product
Change in size and /or shape of a container for non-sterile drug product same or less head/space or contact
area ratio(liquid)
1.3.3. Design Artwork
(color or marketing issue text) Without a change in the scientific content of the label/ related to leaflet
2. Changes specific for sterile drug product
2.1. Minor change in the manufacture of the finished product
2.2. Packaging (Container/Closure System )changes
Change in any part of the primary packaging material not in contact with the finished product formulation (
such as color of the flip-off caps, color code rings on ampoules, change of needle- shield/ different plastic
used
Design Artwork (color or marketing issue text )
3. Common Changes for All Dosage Form
3.1. Change in finished product Specification

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3.1.1. Change in finished product specifications


Tightening of specification limits
Updating specifications to comply with an update of the relevant monograph of the Pharmacopoeia.
3.1.2. Change in test procedure of the finished product
Minor change to an approved test procedure (e.g. a change in column length or temperature, but not a
different type of column or method, within pharmacopoeia changes*²).
3.1.3. Change or addition of imprints
Embossing or other markings (except scoring/break lines) on tablets or printing on capsules, including
replacement, or addition of inks used for product marking (provided that the change in finished product
specification is only in appearance)
3.1.4. Change or addition of scoring/break lines on tablets
For immediate release.
3.2. Package leaflet Changes
Change in style or design (color… size of leaflet) without change in the content.
3.3. Agent / Distributor Change
Agent change for approved Manufacturing Site(MAH)
3.4. Shipment site and/or invoicing company changes
Shipment site and/or invoicing company changes

3.2. Registration Approval Variation List

1. Changes Specific For Solid(Modified Release, Immediate Release) Liquids &


Semisolids Dosage forms
1.1. Manufacturing Site Changes
1.1.1. Secondary Packaging Site
Secondary Packaging Site for all types of pharmaceutical forms
1.1.2. Addition of Manufacturing Site
Secondary Packaging Site for all types of pharmaceutical forms
1.2. Formulation Changes
1.2.1. Immediate Release Solid Dosage Forms
Addition or replacement of an ingredient intended to affect the color, taste or fragrance.
Change in weight of capsule shells by NMT 5%.

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The total additive effect of all excipient changes doesn't exceed 5%, with individual changes within the limits
specified.
The total additive effect of all excipient changes is more than 5 but less than 10% with individual Changes
within the limits specified
Change in weight of capsule shells beyond 5%
Replacement of an excipient with a comparable excipient. (e.g. Magnesium Stearate and Calcium Stearate).
1.2.2. Modified release Solid Dosage Forms
1.2.2.1. Modified release- Non-release Controlling Excipient
Addition or replacement of an ingredient intended to affect the color, taste or fragrance.
Change in weight of capsule shells by NMT 5%.
The total additive effect of all excipient changes doesn't exceed 5%, with individual changes within the limits
specified.
The total additive effect of all excipient changes is more than 5 but less than 10% with individual Changes
within the limits specified
Change in weight of capsule shells beyond 5%
Replacement of an excipient with a comparable excipient. (e.g. Magnesium Stearate and Calcium Stearate).
1.2.2.2. Modified release- Release Controlling Excipient
Changes in the release controlling excipient(s), expressed as percentage (w/w) of total release controlling
excipient(s) in the formulation less than or equal to 5% w/w of total release controlling excipient content.
1.2.3. Non-Sterile Semisolid Dosage Forms (e.g. creams, gels, lotions, & ointments) intended for topical
routes of administration
1.2.3.1. Components and Composition
Up to 5% change in approved amount of an excipient with the total additive effect of all excipient changes ≤
5%. A change in diluent (q.s. excipient) due to component and composition changes in excipient may be
made and is excluded from the 5% change limit.
Change of > 5% and ≤ 10% of approved amount of an excipient with the total additive effect of all excipient
changes ≤ 10% or Change in particle size distribution of the drug substance, if the drug is in suspension.
Changes in diluent (q.s. excipient) due to component and composition changes in excipients are acceptable
and are excluded from the 10% change limit.
1.2.3.2. Components and Composition – Preservative Changes
Quantitatively 20% or less change in the approved amount of preservative
1.2.4. Liquid dosage form
Increase, addition or replacement of one or more components of the color /flavor systems
Changing in percentage of the used excipients.
1.3. Packaging (Container/Closure System) changes
1.3.1. Changes that have moderate potential to have an adverse effect on the product
Change in size and/or shape of a container for non-sterile drug product increase in the head/space or contact
area ratio(liquid)

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Change to a new container closure system


1.3.2. Changing or adding a new pack size of the container of finished product
for solid dosage forms : added or Change in the number of units (ex:tab,cap)
for liquid or semisolid : add or change in pack size (ex: 30gm ,50gm cream).
2. Changes specific for sterile drug product
2.1. Packaging (Container/Closure System )changes
Change in pack size of the finished product(Change in the number of units (e.g. ampoules,vials…. etc.) in a
pack
3. Common Changes for All Dosage Form
3.1. Change in finished product Specification
3.1.1. Change in finished product specifications
Addition of a new test parameter to the specification or deletion of a test parameters
3.1.2. Change in test procedure of the finished product
Other changes to a test procedure, including replacement or addition of a test procedure
3.1.3. Change of dimensions of tablets, capsules, suppositories or pessaries without change in qualitative
or quantitative composition and mean mass(no change in the specifications except dimension)
All other tablets, capsules, suppositories and pessaries
3.2. Shelf life Changes
Reduction of shelf life
After first opening\ after dilution or reconstitution.
3.3. Storage Conditions Changes
Storage Conditions Changes/ after first opening, after dilution or reconstitution.
3.4. Package leaflet Changes
Add Safety information: (warnings, side effects…) .
Changes in the text & format without change in the content.
3.5. Drug Manufacturer Name Change
Manufacturer name change with no change in address
Change in the address name (same physical address) , as change in the name of street, area…
3.6. Trade Name Change of the Drug Product
Change the trade name in the Country of Origin & will be changed for exporting
Change the trade name for export only (Name in the country of origin differ from the name for export).
For local products: Change in the Name for local market.
For local products: Change in the Name for export only.
3.7. Marketing Authorization Holder name & address

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Marketing Authorization Holder name/ address change


Marketing Authorization Holder country
Marketing Authorization Holder transfer to different legal entity
3.8. Change in site responsible for batch release
Change in site responsible for batch release
Active pharmaceutical ingredient changes
3.9. Addition of new (or replacement) drug substance supplier
European Pharmacopoeia certificate of suitability is available
NO European Pharmacopoeia certificate of suitability for an active substance
Change in the name and/or address of API manufacturer
Change in the analytical procedures.
Change in the specifications
Change in the re-testing date
Change in the storage conditions
Update Ph.Eur Certificate of Suitability
Change in manufacturing process
3.10. Change in ATC code.
Change in ATC code
3.11. Change shipment type
Change shipment type
3.12. Change currency for import.
Change currency for import
3.13. Price Change request.
Price Change request

3.3. Technical Committee Approval Variation List

1. Changes Specific For Solid(Modified Release, Immediate Release) Liquids &


Semisolids Dosage forms
1.1. Manufacturing Site Changes
Primary Packaging Site for all types of pharmaceutical forms except for Liquid
Primary Packaging Site for Liquid Dosage forms

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All other manufacturing operations: (Immediate release Modified release oral solid dosage forms , liquid
dosage forms , semisolid dosage form).
1.1.1. Addition of Manufacturing Site
Primary Packaging Site for all types of pharmaceutical forms except for Liquid
Primary Packaging Site for Liquid Dosage forms
All other manufacturing operations: (Immediate release Modified release oral solid dosage forms , liquid
dosage forms , semisolid dosage form).
1.2. Formulation Changes
1.2.1. Immediate Release Solid Dosage Forms
Any change in excipient percent beyond 10% with individual changes are more than the limits specified in 4.
Addition, deletion or changing excipient to a non-comparable excipient
Any qualitative or quantitative change in excipient beyond 5% to a narrow therapeutic drug and low
solubility/low permeability drugs
All other drugs not meeting dissolution criteria under point 4 in this table (did not show similarity in
dissolution f2<50 %)
1.2.2. Modified release Solid Dosage Forms
1.2.2.1. Modified release- Non-release Controlling Excipient
The total additive effect of all excipient changes is more than 10 Or individual changes are more than the
limits specified in point 4 in this table.
Addition, deletion or changing excipients to a non-comparable excipient.
1.2.2.2. Modified release- Release Controlling Excipient
Changes in the release controlling excipient(s), expressed as percentage (w/w) of total release controlling
excipient(s) in the formulation, is more than 5% but less than 10% w/w of total release controlling excipient
content.
Addition or deletion of release controlling excipient(s) (e.g., release controlling polymer/plasticizer)
Changes in the release controlling excipient(s), expressed as percentage (w/w) of total release controlling
excipient(s) in the formulation, greater than those listed above for point 2 (i.e., greater than 10% w/w of total
release controlling excipient content in the modified release solid oral dosage form). (Total weight of the
dosage form may be within or outside the original approved application range).
1.2.3. Non-Sterile Semisolid Dosage Forms (e.g. creams, gels, lotions, & ointments) intended for topical
routes of administration
1.2.3.1. Components and Composition
Any qualitative and quantitative changes in an excipient beyond the ranges ( Changes in the release
controlling excipient(s), expressed as percentage (w/w) of total release controlling excipient(s) in the
formulation, greater than those listed above for point 2 (i.e., greater than 10% w/w of total release
controlling excipient content in the modified release solid oral dosage form). (Total weight of the dosage
form may be within or outside the original approved application range) or Change in crystalline form of the
drug substance, if the drug is in suspension
1.2.3.2. Components and Composition – Preservative Changes
Quantitatively greater than 20% change in the approved amount of preservative (including deletion) or use of

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a different preservative.

1.2.4. Liquid dosage form


Replacement of an excipient with a comparable excipient
Addition, deletion of excipient to a non- comparable excipient.
1.3. Manufacturing Changes
1.3.1. Change in the batch size of the finished product
Other situation (beyond a factor of 10 times) Immediate release,Modified release,Semisolids ,Liquid
1.3.2. Change in the type of process used in the manufacture of the product, such as a change from wet
granulation to direct compression of dry powder: -Immediate release, modifies release
Change in the type of process used in the manufacture of the product, such as a change from wet granulation
to direct compression of dry powder: -Immediate release, modifies release .
1.4. Packaging (Container/Closure System) changes
1.4.1. Changes that have moderate potential to have an adverse effect on the product
Deletion of a desiccant
1.4.2. Changes that have a substantial potential to have an adverse effect on the product
Change to a new container closure system
Deletion of a secondary package component intended to provide additional protection to the product.e.g.
(Carton to protect from light or over wrap to limit transmission of moisture or gases).
2. Changes specific for sterile drug product
2.1. Manufacturing Site Changes
Change in manufacturing site for Aseptically filled product & Terminally sterilized product.(all manufacturing
processes of finished product)
Change in Secondary Packaging Site

2.2. Formulation Changes


Replacement of an excipient with a comparable* excipient

2.3. Packaging (Container/Closure System )changes


Change in shape or dimensions of the container or closure

3. Common Changes for All Dosage Form


3.1. Change in finished product Specification
3.1.1. Change in finished product specifications
Addition of a new test parameter to the specification or deletion of a test parameters
Widening of specification limits or deletion of a test parameter from the specification provided that the
change is not the result of unexpected events arising during manufacture
3.1.2. Change in test procedure of the finished product
Other changes to a test procedure, including replacement or addition of a test procedure

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3.1.3. Change or addition of scoring/break lines on tablets


For modified release (extended and delayed).
3.1.4. Change of dimensions of tablets, capsules, suppositories or pessaries without change in qualitative
or quantitative composition and mean mass(no change in the specifications except dimension)
Gastro-resistant, modified or prolonged release pharmaceutical forms and scored tablets
3.2. Shelf life Changes
Increase of shelf life. (but it doesn't exceed 5 years)
3.3. Package leaflet Changes
Add a new indication.
Add a new dosing regimen, new special patient age group (pediatric, children….), posology and method of
administration

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4. Inquiries

- If a clarification is required, an electronic “Inquiry Form” will be forwarded to the applicant through the
RA manager. The response will be should be received with the inquiry due date. Otherwise, the inquiry
response will be rejected as shown in the figure (17).

Application Inbox Post Inquiry Submit to RA Manager

- All Inquiries forwarded to the RA Manager and it can be edited or deleted or sent to the applicant.

Tasks Pending Inquiries Approve / Edit / Delete

-The Inquiry sender can take an action for the inquiry response by the applicant (comply, not comply or
further inquiry).

Figure (17) – Post an Inquiry

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System workflow
1.1. Submission Process

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1.2. Validation Phase I & Validation Phase II Process

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1.3. Product Approval & Pricing & Certificate Issuing Process

1.4. Appeal Process

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Administration
1. User Activation

- This Part used to activate the public user registration requests.


- The Admin of user activation can approve the user registration request or reject the request.
- When the Admin review the request and press the approve button should be filled the required
information such as:
a- Invoice number.
b- Ministry of trade and industry No.
c- Professions and health institutions license No.
- If the user is existing user it should be linked with oracle stores and drug stores to retrieve the all
registered products and all approved manufacturers and production lines for this store.
- If the user is new user it should be select the new user then press approve button as shown in the
figure (18).

Figure (18) – User Activation

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2. Management

This Menu consists of nine main screens as follow:

1. The 1st one is called Room Allocation.


2. The 2nd one is called Registration Check List.
3. The 3rd one is called Variation Check List.
4. The 4th one is called Appointment Invalidation.
5. The 5th one is called Registration Fees.
6. The 6th one is called Variation Fees.
7. The 7th one is called Tasks.
8. The 8th one is called Application Cancellation.
9. The 9th one is called Pricing Application Cancellation.

2.1.Room Allocation

- This screen used to assign the screeners to a specific days or meeting room or shift as shown in the
figure (19).

Figure (19) - Management- Room Allocation.

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2.2. Registration Check List

- This screen used to define the checklist for new or renew submission as shown in the figure (20).
- The admin can update the version of any checklist.

Figure (20) - Management -Registration Check List

2.3. Variation Check List

- This screen used to define the checklist for variation submission as shown in the figure (21).
- The admin can update the version of any checklist.

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Figure (21) - Management -Variation Check List

2.4. Appointment Invalidation

- This screen used to make an invalidation for the scheduled appointments if the JFDA need to cancel an
appointment for specific reason by using Add Invalidation Rule button as shown in the figure (22).
- The person who authorized to make invalidation for specific appointment is front desk officer and RA
Manager by using Invalidate Button.
- The RA Manager can make invalidation and reschedule another appointment for the invalidated
applications.

Figure (22) - Management - Appointment Invalidation

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2.5. Registration Fees

- This screen used to define the fees for New and Renew submission as shown in the figure (23).

Figure (23) - Management – Registration Fees.

2.6. Variation Fees

- This screen used to define the fees for variation submission as shown in the figure (24).

Figure (24) - Management – Variation Fees.

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2.7. Tasks

- This screen used to track all the tasks in the system and for reassign the open tasks from user to
another user as shown in the figure (25).

Figure (25) - Management – Tasks

2.8.Application Cancellation

- This screen used to extend or cancel the applications that have more than 30 days of deficiencies
letter as shown in the figure (26).
- The RA Manager can extend the application for another 30 days.
- The RA Manager can cancel the application then the applicant should apply a new application with
new appointment.

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Figure (26) - Management – Application Cancellation

2.9.Pricing Application Cancellation

- This screen used to cancel the applications that have more than 90 days of LF2 applicant response or
more than 90 days of Pricing Appeal committee approval decision date.
- The Pricing Head can cancel the application then the applicant should apply a new application with
new appointment.

3. Activity Log

- This screen used to display all actions that happened in the application except the view actions
to make a control for all update or delete actions.
- This screen used to display the actions that happened in the system as follow:
a- The user activation approval or rejection
b- Updated fields by screener.
c- Updated fields by First Reviewer.
d- Updated fields for the inquiry from RA Manager
e- Update Pricing fields from members (when this page gets implemented)
f- Edit , Suspend , Cancel for registered products
g- Activate or Deactivate for public & Organization Users
h- Change the Email & password for the organization Users
i- Cancel the applications from RA Manager or Pricing Head
j- Reassign for tasks
k- Invalidate or invalidate & Reschedule for appointments
l- Invalidation Rules
m- Update for Registration & Variation check list
n- Update for Registration & Variation fees
o- Update the Lookups or delete
p- Add or remove roles from users
q- Add new organization users

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4. Lookups

- This screen used to update or delete the ATC Code lookups or Storage conditions lookups.
- The admin cannot make any delete action for any record used into submitted application.

5. User Management
- This screen used to add a new organization users and give a roles or permissions for the organization
users.
- This screen used to view the information and activate / deactivate the public and organization users.
- This screen used to reset the email or password for the organization users.

6. Products
- This screen used to view all registered products in JFDA.
- Used to edit the marketed or rational information by RA Manager.
- Used to cancel or suspend the registered products.
- Used to view all registration process for the registered products.
- Used to view the certificates of registered products.
- Used to view all related attachments of the registered products.

7. Applications
- This screen used to view all submitted applications to JFDA by applicants.
- Used to view the status of submitted applications.
- Used to view the submitted application report.

8. Reports
8.1. Application Report
8.2. Appointment Report
8.3. Organization Users Report
8.4. Public Users Report
8.5. Tasks Report
8.6. Pricing Report

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Applications Forms
1. MEDICINE: Originator
Step 1: (Application Type)
Application Sub Concern: ………………………………………………………………………
Active Ingredient Type: …………………………………………………………………………
Line Extension Type: ………………………………………………………………………
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: …………………………………………………………………….
Name of MAH: ………………………………………………………………………………..
Office Address: ……………………………………………………………………………......
Step 2: (Ingredients)
Add New Ingredients

Name of Active Ingredient(s): ………………………………………………………………………..


Quantity: ………………………………………
API Reference :
Monograph; Monograph Name: ………………………….
In House
Specification No. : ………………………………………………..
Specification Date: ……………………………………………….

Add New Excipient

Name of Excipient(s): ……………………………………………………………….


Quantity: ……………………………………………………………………………
Excipient Reference:
Monograph; Monograph Name: …………………………………………….
In House
Function: …………………………………………………………………………
Step 3: (ATC Code & Clinical Use)
Dispense Category: ……………………………………………………………………………….
Package Leaflet Revision No.: ………………………………………………………………………………
Package Leaflet Revision Date: ……………………………………………………………………………..
Package Leaflet Type:
Professional
Patient
Indications / Uses of Product: ………………………………………………………………………………
Administration Route: ………………………………………………………………………………………….
Does this product have an ATC Code?
Assigned; ………………………………………………………………………………….
Not Assigned

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Step 4: (Product Information


4.1. General Information
Trade Name in Country of Origin (If Import Drug): …………………………………………………………………………………

Proposed Trade Name in Jordan: …………………………………………………………………………………

Product Strength: …………………………………………………………………………………………………………..

Dosage Form: ………………………………………………………………………………………………………………..

Package Size: ………………………………………………………………………………..

Product Reference Pharmacopeia:

Monograph; Monograph Name: …………………………………………….


In House
Shelf Specification No.: …………………………………

Shelf Specification Date: …………………………………………….

Release Specification No.: ……………………………………………….

Release Specification Date: …………………………………………………

Suggested Public Price: …………………………………………… JOD

Do you have a Diluent as a part of product package? ……………………………

Type of Diluent: ………………………………………..

Packaging Material: …………………………………..

Shelf Life: ………………………………………………

Diluent Specification No.: ……………………………………….

Diluent Specification Date: ……………………………………..

Storage Conditions: …………………………………………

4.2. Packaging Information


Administration Device (if Applicable): …………………………………………………………………….

Primary Packaging: …………………………………………………………………………………………………..

Secondary Packaging: ………………………………………………………………………………………………

Shelf Life: ………………………………………………………………………………………….

Shelf Life after Opening Container: ………………………………………………………………………….

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Shelf Life after Reconstitution or Dilution: ………………………………………………………………………….

Storage Conditions: ………………………………………………………………………………………………………

Storage Conditions after First Opening: …………………………………………………………………………………

4.3. Stability Study


Stability Conditions:

Temperature: ……………………………………………………..℃

Humidity: ……………………………………………………………%

Duration: ……………………………………………………………Month(s)

Light: ………………………………………………………………….Cd

Pressure: …………………………………………………………… Bar

Study Summary Sheets for Every Stability Study:

Batch Number: ……………………………………………………………………….

Batch Size: ………………………………………………………………………

Name of Manufacture: …………………………………………………………..

Date of Manufacture: ………………………………………………………......

Expiry Date: …………………………………………………………………………..

Batch Type: …………………………………………………………………………..

4.4. Other Information


Invoicer: ………………………………………………………

Shipment Country: ………………………………………………………..

 Has CPP from country of Origin?


If Yes;
CPP Country: ……………………..,
CPP No.: ……………………..,
CPP Date: …………………..

 Do you have a marketing authorization (or free sales) certificate from a reference country?

If Yes; Certificate Country: …………….., Certificate No: …………., Certificate Date: ………

If No; Reason: ………………………………………………………………….

 Do you have any material of animal source contained in any component of the product?

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If Yes; Material: ……………….

Animal: …………………

Animal Part: …………………..

Country: …………………………………..

Free From BSE/TSE Certificate Number: ………………………………

Step 5: (Manufacturers)
5.1. Active Ingredient(s) Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
 Is it CEP certified?

IF Yes; CEP No: …………………

IF No; Other Certificate: ……………………………….


Name of active ingredients: ……………………………………………………
5.2. Excipients Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
Name of Excipients: ……………………………………………………

5.3. Finished Product Manufacturer


Is this product under-license?
If Yes; Name of licensor: ………………………..
Finished Product Manufacturing Sites?
Complete
Contract
Manufacturing site type: …………………………………….

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51

Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Plant Address: ……………………………………………………….

5.4. Diluent Manufacturer


Country: ……………………………………………..
Name of manufacturer: ……………………………………………..
Production line: …………………………………………………

Step 6: (Scientific Advice)


Was there any formal scientific advice given by the JFDA for this medicinal product?
If Yes; Scientific Advice Number: ………………….., Scientific advice Date: …………………….

Priority Request
Please Tick the Appropriate box(s) if your application fulfill one or multiple conditions from below as a priority
request:

Therapeutic advantage; Drugs that appears to have Therapeutic advantage / Treat life threatening disease /
an advance over available therapy

First-Second Generic;

Listed on JFDA Website; Drugs listed on JFDA website as market needed

Has a priority approval in reference country; Drugs that approved according to priority in one of the
reference countries
Status of the Application in other Regulatory Agencies
Authorization Description: ……………………………………………………………
Notes: ……………………………………………………………………………………….

2. MEDICINE: Generic application


Step 1: (Application Type)
Application Sub Concern: ………………………………………………………………………
Line Extension Type: ………………………………………………………………………
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: …………………………………………………………………….
Name of MAH: ………………………………………………………………………………..
Office Address: ……………………………………………………………………………......
Step 2: (Ingredients)
Add New Ingredients

Name of Active Ingredient(s): ………………………………………………………………………..

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52

Quantity: ………………………………………
API Reference :
Monograph; Monograph Name: ………………………….
In House
Specification No. : ………………………………………………..
Specification Date: ……………………………………………….

Add New Excipient

Name of Excipient(s): ……………………………………………………………….


Quantity: ……………………………………………………………………………
Excipient Reference:
Monograph; Monograph Name: …………………………………………….
In House
Function: …………………………………………………………………………

Step 3: (ATC Code & Clinical Use)


Dispense Category: ……………………………………………………………………………….
Package Leaflet Revision No.: ………………………………………………………………………………
Package Leaflet Revision Date: ……………………………………………………………………………..
Package Leaflet Type:
Professional
Patient
Indications / Uses of Product: ………………………………………………………………………………
Administration Route: ………………………………………………………………………………………….
Does this product have an ATC Code?
Assigned; ………………………………………………………………………………….
Not Assigned

Step 4: (Product Information


4.1. General Information
Trade Name in Country of Origin (If Import Drug): …………………………………………………………………………………

Proposed Trade Name in Jordan: …………………………………………………………………………………

Product Strength: …………………………………………………………………………………………………………..

Dosage Form: ………………………………………………………………………………………………………………..

Package Size: ………………………………………………………………………………..

Product Reference Pharmacopeia:

Monograph; Monograph Name: …………………………………………….


In House

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53

Shelf Specification No.: …………………………………

Shelf Specification Date: …………………………………………….

Release Specification No.: ……………………………………………….

Release Specification Date: …………………………………………………

Suggested Public Price: …………………………………………… JOD

Do you have a Diluent as a part of product package? ……………………………

Type of Diluent: ………………………………………..

Packaging Material: …………………………………..

Shelf Life: ………………………………………………

Diluent Specification No.: ……………………………………….

Diluent Specification Date: ……………………………………..

Storage Conditions: …………………………………………

4.2. Packaging Information


Administration Device (if Applicable): …………………………………………………………………….

Primary Packaging: …………………………………………………………………………………………………..

Secondary Packaging: ………………………………………………………………………………………………

Shelf Life: ………………………………………………………………………………………….

Shelf Life after Opening Container: ………………………………………………………………………….

Shelf Life after Reconstitution or Dilution: ………………………………………………………………………….

Storage Conditions: ………………………………………………………………………………………………………

Storage Conditions after First Opening: …………………………………………………………………………………

4.3. Stability Study


Stability Conditions:

Temperature: ……………………………………………………..℃

Humidity: ……………………………………………………………%

Duration: ……………………………………………………………Month(s)

Light: ………………………………………………………………….Cd

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Pressure: …………………………………………………………… Bar

Study Summary Sheets for Every Stability Study:

Batch Number: ……………………………………………………………………….

Batch Size: ………………………………………………………………………

Name of Manufacture: …………………………………………………………..

Date of Manufacture: ………………………………………………………......

Expiry Date: …………………………………………………………………………..

Batch Type: …………………………………………………………………………..

4.4. Other Information


Invoicer: ………………………………………………………

Shipment Country: ………………………………………………………..

 Has CPP from country of Origin?

If Yes; CPP Country: …………………….., CPP No.: …………………….., CPP Date: …………………..

If No;

 Do you have a marketing authorization (or free sales) certificate from a reference country?

If Yes; Certificate Country: …………….., Certificate No: …………., Certificate Date: ………

If No; Reason: ………………………………………………………………….

 Do you have any material of animal source contained in any component of the product?

If Yes; Material: ……………….

Animal: …………………

Animal Part: …………………..

Country: …………………………………..

Free From BSE/TSE Certificate Number: ………………………………

Step 5: (Manufacturers)
5.1. Active Ingredient(s) Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….

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Plant address: …………………………………………………………………..


Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
 Is it CEP certified?

Yes; CEP No.: …………………

No; Other Certificate: ……………………………….


Name of active ingredients: ……………………………………………………

5.2. Excipients Manufacturer


Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
Name of Excipients: ……………………………………………………

5.3. Finished Product Manufacturer


Is this product under-license?
Yes; Name of licensor: ………………………..
No
Finished Product Manufacturing Sites?
Complete
Contract
Manufacturing site type: …………………………………….

Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Plant Address: ……………………………………………………….

5.4. Diluent Manufacturer


Country: ……………………………………………..

Name of manufacturer: ……………………………………………..


Production line: …………………………………………………

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Step 6: (Bioequivalence)
 Does this Product have a Bioequivalence Study?
If Yes:
Study Title: …………………………………
Study Protocol No: ………………………… Study Protocol Date: ……………………..
Study Condition: Fed, Fast
Study Initiation Date for Period I: ……………… Study Initiation Date for Period II: ……………………….
Clinical Site: ……………….. Clinical Country: ……………………..
Bio-analytical Site: ……………………… Bio-analytical Country: ………………………..
Bio-analytical Completion Date: …………………………………….
Clinical site / Inspection Report GCP Date From: …………………..To: ………………………
Bio-analytical Site / Inspection Report GLP Date From: …………………….To: ……………….
If No;
 Is it Bio-waiver Request or other type?
If Bio-waiver Request:
BW Request Reason: ………………
 Dissolution?
If Yes;
Dissolution Method: ………………….

Proof of dose proportionality: …………..

If No; Study Type: ……………..


If Other Study;
Study Title: ……………………………………
Study Protocol No: ………………………… Study Protocol Date: ……………………..
Study Condition: Fed, Fast
Study Initiation Date for Period I: ……………… Study Initiation Date for Period II: ……………………….
Clinical Site: ……………….. Clinical Country: ……………………..
Bio-analytical Site: ……………………… Bio-analytical Country: ………………………..
Bio-analytical Completion Date: …………………………………….
Clinical site / Inspection Report GCP Date From: ………………….. To: ………………………
Bio-analytical Site / Inspection Report GLP Date From: …………………….To: ………………………

Reference Products Information


Reference Product Name: …………………………..
Reference product strength : ………………………………
Reference product dosage form : ……………………………
Manufacturer : ………………………..
If COA:
Marketing Authorization Holder (MAH) : ………………………..
Bio-batch No : …………………
Test Products Information
Bio-batch Manufacturer: ……………………
API Source : ………………….
Master Formula No : …………………
Master Formula Date: ……………..
Bio-batch No : ……………….
Bio-batch Size : …………………..
Bio-batch Type:

Pilot

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57

Production
If COA: …………………………………………………….
Step 7: (Scientific Advice)
 Was there any formal scientific advice given by the JFDA for this medicinal product?
If Yes; Scientific Advice Number: …................. Scientific advice Date: …………………….

Priority Request
Please Tick the Appropriate box(s) if your application fulfill one or multiple conditions from below as a priority
request:

Therapeutic advantage; Drugs that appears to have Therapeutic advantage / Treat life threatening disease /
an advance over available therapy

First-Second Generic;

Listed on JFDA Website; Drugs listed on JFDA website as market needed

Has a priority approval in reference country; Drugs that approved according to priority in one of the
reference countries

Status of the Application in other Regulatory Agencies


Authorization Description: ……………………………………………………………
Notes: ……………………………………………………………………………………….

3. MEDICINE: Herbal Drug


Step 1: (Application Type)
Application Sub Concern: ………………………………………………………………………
Active Ingredient Type: …………………………………………………………………………
Line Extension Type: ………………………………………………………………………
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: …………………………………………………………………….
Name of MAH: ………………………………………………………………………………..
Office Address: ……………………………………………………………………………......

Step 2: (Ingredients)
Add New Ingredients

Name of Active Ingredient(s): ………………………………………………………………………..


Quantity: ………………………………………
API Reference :
Monograph; Monograph Name: ………………………….
In House
Specification No. : ………………………………………………..
Specification Date: ……………………………………………….

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Add New Excipient

Name of Excipient(s): ……………………………………………………………….


Quantity: ……………………………………………………………………………
Excipient Reference:
Monograph; Monograph Name: …………………………………………….
In House
Function: …………………………………………………………………………

Step 3: (ATC Code & Clinical Use)


Dispense Category: ……………………………………………………………………………….
Package Leaflet Revision No.: ………………………………………………………………………………
Package Leaflet Revision Date: ……………………………………………………………………………..
Package Leaflet Type:
Professional
Patient
Indications / Uses of Product: ………………………………………………………………………………
Administration Route: ………………………………………………………………………………………….
Does this product have an ATC Code?
Assigned; ………………………………………………………………………………….
Not Assigned

Step 4: (Product Information


4.1. General Information
Trade Name in Country of Origin (If Import Drug): …………………………………………………………………………………

Proposed Trade Name in Jordan: …………………………………………………………………………………

Product Strength: …………………………………………………………………………………………………………..

Dosage Form: ………………………………………………………………………………………………………………..

Package Size: ………………………………………………………………………………..

Product Reference Pharmacopeia:

Monograph; Monograph Name: …………………………………………….


In House
Shelf Specification No.: …………………………………

Shelf Specification Date: …………………………………………….

Release Specification No.: ……………………………………………….

Release Specification Date: …………………………………………………

Suggested Public Price: …………………………………………… JOD

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Do you have a Diluent as a part of product package? ……………………………

Type of Diluent: ………………………………………..

Packaging Material: …………………………………..

Shelf Life: ………………………………………………

Diluent Specification No.: ……………………………………….

Diluent Specification Date: ……………………………………..

Storage Conditions: …………………………………………


4.2. Packaging Information
Administration Device (if Applicable): …………………………………………………………………….

Primary Packaging: …………………………………………………………………………………………………..

Secondary Packaging: ………………………………………………………………………………………………

Shelf Life: ………………………………………………………………………………………….

Shelf Life after Opening Container: ………………………………………………………………………….

Shelf Life after Reconstitution or Dilution: ………………………………………………………………………….

Storage Conditions: ………………………………………………………………………………………………………

Storage Conditions after First Opening: …………………………………………………………………………………

4.3. Stability Study


Stability Conditions:

Temperature: ……………………………………………………..℃

Humidity: ……………………………………………………………%

Duration: ……………………………………………………………Month(s)

Light: ………………………………………………………………….Cd

Pressure: …………………………………………………………… Bar

Study Summary Sheets for Every Stability Study:

Batch Number: ……………………………………………………………………….

Batch Size: ………………………………………………………………………

Name of Manufacture: …………………………………………………………..

Date of Manufacture: ………………………………………………………......

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Expiry Date: …………………………………………………………………………..

Batch Type: …………………………………………………………………………..

4.4. Other Information


Invoicer: ………………………………………………………

Shipment Country: ………………………………………………………..

 Has CPP from country of Origin?


If Yes;
CPP Country: …………………….., CPP No.: ……………………..,CPP Date: …………………..
 Do you have a marketing authorization (or free sales) certificate from a reference country?

If Yes; Certificate Country: …………….., Certificate No: …………., Certificate Date: ………

If No; Reason: ………………………………………………………………….

 Do you have any material of animal source contained in any component of the product?

If Yes; Material: ……………….

Animal: …………………

Animal Part: …………………..

Country: …………………………………..

Free From BSE/TSE Certificate Number: ………………………………

Step 5: (Manufacturers)
5.1. Active Ingredient(s) Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..

Activity: ………………………………………………..
 Is it CEP certified?

IF Yes; CEP No: …………………

IF No; Other Certificate: ……………………………….

Name of active ingredients: ……………………………………………………

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5.2. Excipients Manufacturer


Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
Name of Excipients: ……………………………………………………

5.3. Finished Product Manufacturer


Is this product under-license?
If Yes; Name of licensor: ………………………..
Finished Product Manufacturing Sites?
Complete
Contract
Manufacturing site type: …………………………………….

Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Plant Address: ……………………………………………………….

5.4. Diluent Manufacturer


Country: ……………………………………………..

Name of manufacturer: ……………………………………………..


Production line: …………………………………………………

Step 6: (Scientific Advice)


Was there any formal scientific advice given by the JFDA for this medicinal product?
If Yes; Scientific Advice Number: ………………….., Scientific advice Date: …………………….

Priority Request
 Please Tick the Appropriate box(s) if your application fulfill one or multiple conditions from below as a
priority request:

Therapeutic advantage; Drugs that appears to have Therapeutic advantage / Treat life threatening disease /
an advance over available therapy

First-Second Generic.

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Listed on JFDA Website; Drugs listed on JFDA website as market needed

Has a priority approval in reference country; Drugs that approved according to priority in one of the
reference countries

Status of the Application in other Regulatory Agencies


Authorization Description: ……………………………………………………………
Notes: ……………………………………………………………………………………….

4. MEDICINE: New Drug application


Step 1: (Application Type)
Application Sub Concern: ………………………………………………………………………
Line Extension Type: ………………………………………………………………………
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: …………………………………………………………………….
Name of MAH: ………………………………………………………………………………..
Office Address: ……………………………………………………………………………......

Step 2: (Ingredients)
Add New Ingredients

Name of Active Ingredient(s): ………………………………………………………………………..


Quantity: ………………………………………
API Reference :
Monograph; Monograph Name: ………………………….
In House
Specification No. : ………………………………………………..
Specification Date: ……………………………………………….

Add New Excipient

Name of Excipient(s): ……………………………………………………………….


Quantity: ……………………………………………………………………………
Excipient Reference:
Monograph; Monograph Name: …………………………………………….
In House
Function: …………………………………………………………………………

Step 3: (ATC Code & Clinical Use)


Dispense Category: ……………………………………………………………………………….
Package Leaflet Revision No.: ………………………………………………………………………………
Package Leaflet Revision Date: ……………………………………………………………………………..

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Package Leaflet Type:


Professional
Patient
Indications / Uses of Product: ………………………………………………………………………………
Administration Route: ………………………………………………………………………………………….
Does this product have an ATC Code?
Assigned; ………………………………………………………………………………….
Not Assigned

Step 4: (Product Information


4.1. General Information
Trade Name in Country of Origin (If Import Drug): …………………………………………………………………………………

Proposed Trade Name in Jordan: …………………………………………………………………………………

Product Strength: …………………………………………………………………………………………………………..

Dosage Form: ………………………………………………………………………………………………………………..

Package Size: ………………………………………………………………………………..

Product Reference Pharmacopeia:

Monograph; Monograph Name: …………………………………………….


In House

Shelf Specification No.: …………………………………

Shelf Specification Date: …………………………………………….

Release Specification No.: ……………………………………………….

Release Specification Date: …………………………………………………

Suggested Public Price: …………………………………………… JOD

Do you have a Diluent as a part of product package? ……………………………

Type of Diluent: ………………………………………..

Packaging Material: …………………………………..

Shelf Life: ………………………………………………

Diluent Specification No.: ……………………………………….

Diluent Specification Date: ……………………………………..

Storage Conditions: …………………………………………

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4.2. Packaging Information


Administration Device (if Applicable): …………………………………………………………………….

Primary Packaging: …………………………………………………………………………………………………..

Secondary Packaging: ………………………………………………………………………………………………

Shelf Life: ………………………………………………………………………………………….

Shelf Life after Opening Container: ………………………………………………………………………….

Shelf Life after Reconstitution or Dilution: ………………………………………………………………………….

Storage Conditions: ………………………………………………………………………………………………………

Storage Conditions after First Opening: …………………………………………………………………………………

4.3. Stability Study


Stability Conditions:

Temperature: ……………………………………………………..℃

Humidity: ……………………………………………………………%

Duration: ……………………………………………………………Month(s)

Light: ………………………………………………………………….Cd

Pressure: …………………………………………………………… Bar

Study Summary Sheets for Every Stability Study:

Batch Number: ……………………………………………………………………….

Batch Size: ………………………………………………………………………

Name of Manufacture: …………………………………………………………..

Date of Manufacture: ………………………………………………………......

Expiry Date: …………………………………………………………………………..

Batch Type: …………………………………………………………………………..

4.4. Other Information


Invoicer: ………………………………………………………

Shipment Country: ………………………………………………………..

 Has CPP from country of Origin?

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If Yes; CPP Country: …………………….., CPP No.: …………………….., CPP Date: …………………..

If No;

 Do you have a marketing authorization (or free sales) certificate from a reference country?

If Yes; Certificate Country: …………….., Certificate No: …………., Certificate Date: ………

If No; Reason: ………………………………………………………………….

 Do you have any material of animal source contained in any component of the product?

If Yes; Material: ……………….

Animal: …………………

Animal Part: …………………..

Country: …………………………………..

Free From BSE/TSE Certificate Number: ………………………………

Step 5: (Manufacturers)
5.1. Active Ingredient(s) Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
 Is it CEP certified?

Yes; CEP No.: …………………

No; Other Certificate: ……………………………….


Name of active ingredients: ……………………………………………………
5.2. Excipients Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..

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Name of Excipients: ……………………………………………………

5.3. Finished Product Manufacturer


Is this product under-license?
Yes; Name of licensor: ………………………..
No
Finished Product Manufacturing Sites?
Complete
Contract
Manufacturing site type: …………………………………….

Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Plant Address: ……………………………………………………….

5.4. Diluent Manufacturer


Country: ……………………………………………..
Name of manufacturer: ……………………………………………..
Production line: …………………………………………………

Step 6: (Bioequivalence)
 Does this Product have a Bioequivalence Study?
If Yes:
Study Title: …………………………………
Study Protocol No: ………………………… Study Protocol Date: ……………………..
Study Condition: Fed, Fast
Study Initiation Date for Period I: ……………… Study Initiation Date for Period II: ……………………….
Clinical Site: ……………….. Clinical Country: ……………………..
Bio-analytical Site: ……………………… Bio-analytical Country: ………………………..
Bio-analytical Completion Date: …………………………………….
Clinical site / Inspection Report GCP Date From: …………………..To: ………………………
Bio-analytical Site / Inspection Report GLP Date From: …………………….To: ……………….
If No;
 Is it Bio-waiver Request or other type?
If Bio-waiver Request:
BW Request Reason: ………………
 Dissolution?
If Yes;
Dissolution Method: ………………….

Proof of dose proportionality: …………..

If No; Study Type: ……………..


If Other Study;
Study Title: ……………………………………

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Study Protocol No: ………………………… Study Protocol Date: ……………………..


Study Condition: Fed, Fast
Study Initiation Date for Period I: ……………… Study Initiation Date for Period II: ……………………….
Clinical Site: ……………….. Clinical Country: ……………………..
Bio-analytical Site: ……………………… Bio-analytical Country: ………………………..
Bio-analytical Completion Date: …………………………………….
Clinical site / Inspection Report GCP Date From: ………………….. To: ………………………
Bio-analytical Site / Inspection Report GLP Date From: …………………….To: ………………………

Reference Products Information


Reference Product Name: …………………………..
Reference product strength : ………………………………
Reference product dosage form : ……………………………
Manufacturer : ………………………..
If COA:
Marketing Authorization Holder (MAH) : ………………………..
Bio-batch No : …………………
Test Products Information
Bio-batch Manufacturer: ……………………
API Source : ………………….
Master Formula No : …………………
Master Formula Date: ……………..
Bio-batch No : ……………….
Bio-batch Size : …………………..
Bio-batch Type:

Pilot

Production
If COA: …………………………………………………….
Step 7: (Scientific Advice)
 Was there any formal scientific advice given by the JFDA for this medicinal product?
If Yes; Scientific Advice Number: …................. Scientific advice Date: …………………….

Priority Request
Please Tick the Appropriate box(s) if your application fulfill one or multiple conditions from below as a priority
request:

Therapeutic advantage; Drugs that appears to have Therapeutic advantage / Treat life threatening disease /
an advance over available therapy

First-Second Generic; First – Second Generic

Listed on JFDA Website; Drugs listed on JFDA website as market needed

Has a priority approval in reference country; Drugs that approved according to priority in one of the
reference countries

Status of the Application in other Regulatory Agencies


Authorization Description: ……………………………………………………………
Notes: ……………………………………………………………………………………….

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5. MEDICINE: BIOLOGICAL
Step 1: (Application Type)
Application Sub Concern: ………………………………………………………………………
Active Ingredient Type: …………………………………………………………………………
Line Extension Type: ………………………………………………………………………
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: …………………………………………………………………….
Name of MAH: ………………………………………………………………………………..
Office Address: ……………………………………………………………………………......
Step 2: (Ingredients)
Add New Ingredients

Name of Active Ingredient(s): ………………………………………………………………………..


Quantity: ………………………………………
API Reference :
Monograph; Monograph Name: ………………………….
In House
Specification No. : ………………………………………………..
Specification Date: ……………………………………………….

Add New Excipient

Name of Excipient(s): ……………………………………………………………….


Quantity: ……………………………………………………………………………
Excipient Reference:
Monograph; Monograph Name: …………………………………………….
In House
Function: …………………………………………………………………………

Step 3: (ATC Code & Clinical Use)


Dispense Category: ……………………………………………………………………………….
Package Leaflet Revision No.: ………………………………………………………………………………
Package Leaflet Revision Date: ……………………………………………………………………………..
Package Leaflet Type:
Professional
Patient
indications / Uses of Product: ………………………………………………………………………………
Administration Route: ………………………………………………………………………………………….

Does this product have an ATC Code?


Assigned; ………………………………………………………………………………….
Not Assigned

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Step 4: (Product Information


4.1. General Information
Trade Name in Country of Origin (If Import Drug): …………………………………………………………………………………

Proposed Trade Name in Jordan: …………………………………………………………………………………

Product Strength: …………………………………………………………………………………………………………..

Dosage Form: ………………………………………………………………………………………………………………..

Package Size: ………………………………………………………………………………..

Product Reference Pharmacopeia:

Monograph; Monograph Name: …………………………………………….


In House
Shelf Specification No.: …………………………………

Shelf Specification Date: …………………………………………….

Release Specification No.: ……………………………………………….

Release Specification Date: …………………………………………………

Suggested Public Price: …………………………………………… JOD

Do you have a Diluent as a part of product package?

If Yes; Type of Diluent: ………………………………………..

Packaging Material: …………………………………..

Shelf Life: ………………………………………………

Diluent Specification No.: ……………………………………….

Diluent Specification Date: ……………………………………..

Storage Conditions: …………………………………………


4.2. Packaging Information
Administration Device (if Applicable): …………………………………………………………………….

Primary Packaging: …………………………………………………………………………………………………..

Secondary Packaging: ………………………………………………………………………………………………

Shelf Life: ………………………………………………………………………………………….

Shelf Life after Opening Container: ………………………………………………………………………….

Shelf Life after Reconstitution or Dilution: ………………………………………………………………………….

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Storage Conditions: ………………………………………………………………………………………………………

Storage Conditions after First Opening: …………………………………………………………………………………

4.3. Stability Study


Stability Conditions:

Temperature: ……………………………………………………..℃

Humidity: ……………………………………………………………%

Duration: ……………………………………………………………Month(s)

Light: ………………………………………………………………….Cd

Pressure: …………………………………………………………… Bar

Study Summary Sheets for Every Stability Study:

Batch Number: ……………………………………………………………………….

Batch Size: ………………………………………………………………………

Name of Manufacture: …………………………………………………………..

Date of Manufacture: ………………………………………………………......

Expiry Date: …………………………………………………………………………..

Batch Type: …………………………………………………………………………..

4.4. Other Information


Invoicer: ………………………………………………………

Shipment Country: ………………………………………………………..

 Has CPP from country of Origin?


If Yes;
CPP Country: …………………….., CPP No.: …………………….., CPP Date: …………………..

 Do you have a marketing authorization (or free sales) certificate from a reference country?

If Yes; Certificate Country: …………….., Certificate No: …………., Certificate Date: ………

If No; Reason: ………………………………………………………………….

 Do you have any material of animal source contained in any component of the product?

If Yes; Material: ……………….

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Animal: …………………

Animal Part: …………………..

Country: …………………………………..

Free From BSE/TSE Certificate Number: ………………………………

Step 5: (Manufacturers)
5.1. Active Ingredient(s) Manufacturer
Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Name of Active Ingredient: ……………………………………………………………..

5.2. Excipients Manufacturer


Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Name of Excipient: ……………………………………………………………..


5.3. Finished Product Manufacturer
Is this product under-license?
If Yes; Name of licensor: ………………………..
Finished Product Manufacturing Sites?
Complete
Contract
Manufacturing site type: …………………………………….

Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Plant Address: ……………………………………………………….

5.4. Diluent Manufacturer


Country: ……………………………………………..
Name of manufacturer: ……………………………………………..
Production line: …………………………………………………

Step 6: (Scientific Advice)


Was there any formal scientific advice given by the JFDA for this medicinal product?

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If Yes; Scientific Advice Number: ………………….., Scientific advice Date: …………………….

Priority Request
Please Tick the Appropriate box(s) if your application fulfill one or multiple conditions from below as a priority
request:

Therapeutic advantage; Drugs that appears to have Therapeutic advantage / Treat life threatening disease /
an advance over available therapy

First-Second Generic; First – Second Generic

Listed on JFDA Website; Drugs listed on JFDA website as market needed

Has a priority approval in reference country; Drugs that approved according to priority in one of the
reference countries

Status of the Application in other Regulatory Agencies


Authorization Description: ……………………………………………………………
Notes: ……………………………………………………………………………………….

6. MEDICINE: Radiopharmaceutical
Step 1: (Application Type)
Application Sub Concern: ………………………………………………………………………
Active Ingredient Type: …………………………………………………………………………
Line Extension Type: ………………………………………………………………………
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: …………………………………………………………………….
Name of MAH: ………………………………………………………………………………..
Office Address: ……………………………………………………………………………......
Step 2: (Ingredients)
Add New Ingredients

Name of Active Ingredient(s): ………………………………………………………………………..


Quantity: ………………………………………
API Reference :
Monograph; Monograph Name: ………………………….
In House
Specification No. : ………………………………………………..
Specification Date: ……………………………………………….
Add New Excipient

Name of Excipient(s): ……………………………………………………………….


Quantity: ……………………………………………………………………………

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Excipient Reference:
Monograph; Monograph Name: …………………………………………….
In House
Function: …………………………………………………………………………

Step 3: (ATC Code & Clinical Use)


Dispense Category: ……………………………………………………………………………….
Package Leaflet Revision No.: ………………………………………………………………………………
Package Leaflet Revision Date: ……………………………………………………………………………..
Package Leaflet Type:
Professional
Patient
Indications / Uses of Product: ………………………………………………………………………………
Administration Route: ………………………………………………………………………………………….
Does this product have an ATC Code?
Assigned; ………………………………………………………………………………….
Not Assigned

Step 4: (Product Information


4.1. General Information
Trade Name in Country of Origin (If Import Drug): …………………………………………………………………………………

Proposed Trade Name in Jordan: …………………………………………………………………………………

Product Strength: …………………………………………………………………………………………………………..

Dosage Form: ………………………………………………………………………………………………………………..

Package Size: ………………………………………………………………………………..

Product Reference Pharmacopeia:

Monograph; Monograph Name: …………………………………………….


In House
Shelf Specification No.: …………………………………

Shelf Specification Date: …………………………………………….

Release Specification No.: ……………………………………………….

Release Specification Date: …………………………………………………

Suggested Public Price: …………………………………………… JOD

Do you have a Diluent as a part of product package? ……………………………

Type of Diluent: ………………………………………..

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Packaging Material: …………………………………..

Shelf Life: ………………………………………………

Diluent Specification No.: ……………………………………….

Diluent Specification Date: ……………………………………..

Storage Conditions: …………………………………………

4.2. Packaging Information


Administration Device (if Applicable): …………………………………………………………………….

Primary Packaging: …………………………………………………………………………………………………..

Secondary Packaging: ………………………………………………………………………………………………

Shelf Life: ………………………………………………………………………………………….

Shelf Life after Opening Container: ………………………………………………………………………….

Shelf Life after Reconstitution or Dilution: ………………………………………………………………………….

Storage Conditions: ………………………………………………………………………………………………………

Storage Conditions after First Opening: …………………………………………………………………………………

4.3. Stability Study


Stability Conditions:

Temperature: ……………………………………………………..℃

Humidity: ……………………………………………………………%

Duration: ……………………………………………………………Month(s)

Light: ………………………………………………………………….Cd

Pressure: …………………………………………………………… Bar

Study Summary Sheets for Every Stability Study:

Batch Number: ……………………………………………………………………….

Batch Size: ………………………………………………………………………

Name of Manufacture: …………………………………………………………..

Date of Manufacture: ………………………………………………………......

Expiry Date: …………………………………………………………………………..

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Batch Type: …………………………………………………………………………..

4.4. Other Information


Invoicer: ………………………………………………………

Shipment Country: ………………………………………………………..

 Has CPP from country of Origin?


If Yes;
CPP Country: …………………….., CPP No.: …………………….., CPP Date: …………………..

 Do you have a marketing authorization (or free sales) certificate from a reference country?

If Yes; Certificate Country: …………….., Certificate No: …………., Certificate Date: ………

If No; Reason: ………………………………………………………………….

 Do you have any material of animal source contained in any component of the product?

Yes; Material: ……………….

Animal: …………………

Animal Part: …………………..

Country: …………………………………..

Free From BSE/TSE Certificate Number: ………………………………

Step 5: (Manufacturers)
5.1. Active Ingredient(s) Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
 Is it CEP certified?

IF Yes; CEP No: …………………

IF No; Other Certificate: ……………………………….


Name of active ingredients: ……………………………………………………

5.2. Excipients Manufacturer


Name of supplier: ……………………………………………………….

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Name of manufacturer: ……………………………………………….


Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
Name of Excipients: ……………………………………………………

5.3. Finished Product Manufacturer


Is this product under-license?
If Yes; Name of licensor: ………………………..
Finished Product Manufacturing Sites?
Complete
Contract
Manufacturing site type: …………………………………….

Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Plant Address: ……………………………………………………….

5.4. Diluent Manufacturer


Country: ……………………………………………..

Name of manufacturer: ……………………………………………..


Production line: …………………………………………………

Step 6: (Scientific Advice)


Was there any formal scientific advice given by the JFDA for this medicinal product?
If Yes; Scientific Advice Number: ………………….., Scientific advice Date: …………………….

Priority Request
Please Tick the Appropriate box(s) if your application fulfill one or multiple conditions from below as a priority
request:

Therapeutic advantage; Drugs that appears to have Therapeutic advantage / Treat life threatening disease /
an advance over available therapy

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First-Second Generic; First – Second Generic

Listed on JFDA Website; Drugs listed on JFDA website as market needed

Has a priority approval in reference country; Drugs that approved according to priority in one of the
reference countries
Status of the Application in other Regulatory Agencies
Authorization Description: ……………………………………………………………
Notes: ……………………………………………………………………………………….

7. Herbal & Vitamins product


Step 1: (Application Type)
Active Ingredient Type: ………………………………………………………..
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: ………………………………………………………..
Name of MAH: ………………………………………………………..
Office Address: ………………………………………………………..
Step 2: (Ingredients)

Add New Ingredient

Name of Active Ingredient(s) :………………………………………………..


Quantity: ……………………………………………….
API Reference:
Monograph
In House
Specification No. :…………………………………….
Specification Date: ……………………………..
Product Active Ingredient Type: Extract, Crude (Powder), Other ………………………………

Add New Excipient

Name of Excipient(s): ……………………………………….


Quantity: ………………………………………………..
ExcipientReference:
Monograph
In House
Function: …………………………………………………………….
Step 3: (Product Claims)
Dispense Category: ………………………………………………………
Proposed Package Leaflet Revision Number: ………………………………………………………
Proposed Package Leaflet Revision Date: ………………………………………………………

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Package Type:
Professional
Patient
Product Claims: ………………………………………………………
Administration Route: ………………………………………………………

Step 4: (Product Information


4.1. General Information
Trade Name in Country of Origin (If Import Drug): …………………………………………………………………………………

Proposed Trade Name in Jordan: …………………………………………………………………………………

Product Strength: …………………………………………………………………………………………………………..

Dosage Form: ………………………………………………………………………………………………………………..

Package Size: ………………………………………………………………………………..

Product Reference Pharmacopeia:

Monograph; Monograph Name: …………………………………………….


In House
Shelf Specification No.: …………………………………

Shelf Specification Date: …………………………………………….

Release Specification No.: ……………………………………………….

Release Specification Date: …………………………………………………

4.2. Packaging Information


Administration Device (if Applicable): …………………………………………………………………….

Primary Packaging: …………………………………………………………………………………………………..

Secondary Packaging: ………………………………………………………………………………………………

Shelf Life: ………………………………………………………………………………………….

Shelf Life after Opening Container: ………………………………………………………………………….

Shelf Life after Reconstitution or Dilution: ………………………………………………………………………….

Storage Conditions: ………………………………………………………………………………………………………

Storage Conditions after First Opening: …………………………………………………………………………………

4.3. Stability Study


Stability Conditions:

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Temperature: ……………………………………………………..℃

Humidity: ……………………………………………………………%

Duration: ……………………………………………………………Month(s)

Light: ………………………………………………………………….Cd

Pressure: …………………………………………………………… Bar

Study Summary Sheets for Every Stability Study:

Batch Number: ……………………………………………………………………….

Batch Size: ………………………………………………………………………

Name of Manufacture: …………………………………………………………..

Date of Manufacture: ………………………………………………………......

Expiry Date: …………………………………………………………………………..

Batch Type: …………………………………………………………………………..

4.4. Other Information


Invoicer: ………………………………………………………

Shipment Country: ………………………………………………………..

 Has CPP from country of Origin?


If Yes;
CPP Country: …………………,CPP No.: …………………….., CPP Date: …………………..

 Do you have a marketing authorization (or free sales) certificate from a reference country?

If Yes; Certificate Country: …………….., Certificate No: …………., Certificate Date: ………

If No; Reason: ………………………………………………………………….

 Do you have any material of animal source contained in any component of the product?

If Yes; Material: ……………….

Animal: …………………

Animal Part: …………………..

Country: …………………………………..

Free From BSE/TSE Certificate Number: ………………………………

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Step 5: (Manufacturers)
5.1. Active Ingredient(s) Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
 Is it CEP certified?

IF Yes; CEP No: …………………

IF No; Other Certificate: ……………………………….


Name of active ingredients: ……………………………………………………
5.2. Excipients Manufacturer
Name of supplier: ……………………………………………………….
Name of manufacturer: ……………………………………………….
Office address: ……………………………………………………………….
Plant address: …………………………………………………………………..
Phone: …………………………………………………..
Fax: ……………………………………………
Postal zip code: ………………………………………..
Country: …………………………………………………..
City: ………………………………………………………..
Activity: ………………………………………………..
Name of Excipients: ……………………………………………………

5.3. Finished Product Manufacturer


Is this product under-license?
If Yes; Name of licensor: ………………………..
Finished Product Manufacturing Sites?
Complete
Contract
Manufacturing site type: …………………………………….

Country: …………………………………………….

Name of manufacturer: ……………………………………….

Production line: …………………………………………………..

Plant Address: ……………………………………………………….

Step6: Classification Letter


 Has Formal Classification Letter:
 Note: Classification letter should be valid for 6 month starting from classification letter date
If Yes; Reference Number: …………………………. Date: ………………………………….

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Status of the Application in other Regulatory Agencies


Authorization Description: ……………………………………………………………
Notes: ……………………………………………………………………………………….

8. Infant Food & Formula Application

Step 1: (Application TYPE)


Active Ingredient Type: ……………………………………..
Submission type:
Local
Import
Marketing Authorization Holder (MAH)
Country: ………………………………………………………..
Name of MAH: ………………………………………………….
Office Address: ……………………………………………………...

Step 2: (PRODUCT INFORMATION)


4.1. General Information
Product Information In Jordan
Proposed Trade Name in Jordan: ……………………………
Net Weight or Volume: ………………………………….
Dosage Forms: ……………………………………..
Type of Container (Primary Packaging): …………………………….
Secondary Packaging: ………………………………….
Shelf Life: ………………………………………..
Administration Device: ………………………………………..
Package Size: ……………………………………………………………….

Product Information In Country of Origin (COO) Copy Jordan Information


Trade Name in Country of Origin: ……………………………………
Net Weight or Volume in Country of Origin: ………………………………
Country of Origin Dosage Form: …………………………………….
Type of Container in Country of Origin (Primary Packaging): ………………………
Secondary Packaging: ………………………………
Shelf Life: …………………………………
Country of Origin Administration Device: ……………………………..
Package Size: ……………………………………………………………………
4.2. Packaging Information
Shelf Life In Nearby Arab Countries: ………………………………………………………….

Shelf Life after First Opening Container: …………………………………………….


Important Preparation Instructions: ………………………………….
Storage Conditions: ………………………………….
Storage Conditions after First Opening: …………………………………….
Proposed Changes in Physical and Chemical Characteristics Of The Product During Storage Transport And
Distribution At 20, 30, 40 C: ……………………………………………………………………………………………………………….

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Instructions for Transport and Storage: ………………………………………..

4.3. Other Information


Invoicer: …………………………….

Suggested Price for the formula: …………………………….


Shipment Country: ……………………………….

Certificate of Free Sales (FSC)


 Do you have an FSC for the Same Formula in COO?
If Yes; Country of FSC: ………………………….. , FSC Number: ……………………………
If No;

 Do You Have A Similar Formula Sold in COO?

If Yes; Specify the Country That Sold The similar Formula: …………………………….

Certificate NO: ……………………………………

If No;

 Do you have FSC from a reference country?

If Yes; Country of Certificate: ……………………………. , Certificate Number:………………………………….

If No; Reason: ………………………………

Quality Control Measures: ………………………………………………………………………..

Step 3: (COMPOSITION)
Country of Origin List of Compositions

Ingredient Name: ………………………………………


Ingredient Sub Name: …………………………….
Ingredient Source: …………………………………….
Manufacturer Name: ………………………………
Manufacturer Country of origin: ………………………………………..
Ingredient shelf life: …………………………………
Type of Container of Ingredient: ……………………………………

Exported To Jordan List of Compositions


Ingredient Name: ………………………………………
Ingredient Sub Name: …………………………….
Ingredient Source: …………………………………….
Manufacturer Name: ………………………………
Manufacturer Country of origin: ………………………………………..
Ingredient shelf: …………………………………
Type of Container of Ingredient: ……………………………………

Formulas Differences & Reasons

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 In case of any differences between the two formulas indicate the difference and specify the reason?
......................................................................................

Step 4: (AVERAGE COMPOSOTION)


Add New Average Composition

Country of Origin List of Average Compositions

Name of Nutrients: ………………………


Nutrient Sub Type Name: ………………………
Percentage per 100 GM: …………………………
Percentage per 100 Kcal: …………………………….

Exported To Jordan List of Average Compositions

Name of Nutrients: ………………………


Nutrient Sub Type Name: ………………………
Percentage per 100 GM: …………………………
Percentage per 100 Kcal: …………………………….

Step 5: (RECOMENDED USE)


Recommended age for using the product: ………………………….
Dietary Use / Management Of: ………………………………..
Warnings / Contra Indications (Cases When It Should Not Be Used): …………………………………
Experimental and Nutritional Studies: ………………………………………

Status of the Application in Other Regulatory Agencies / Other Information: …………………………………….

Step 6: (MANUFACTURERS)
 Is this product under-license?
If Yes; Name of licensor: ………………………….
Finished Product Manufacturing Sites:
Complete
Contract
Add new finished product manufacturer:

Manufacturing site type: ………………………………….

Country: ………………………………

Name of manufacturer: ……………………………

Production line: …………………………………..

Plant Address: ……………………………………

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