APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE

I/we.........................of ................hereby apply for registration of the drug

namely ..................details of which are enclosed.
Date .......................
Place ......................
ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG
1. Name and address of the manufacturer •
2, Name of drug •
(a) Generic/international non-proprietary name:
(b) Proprietory name, if any:
3 Name under which drug is proposed to be sold
4. Dosage from of the drug:
5. Composition of the drug, stating quantity of each active and non-active ingredient(s) per
unit or as a percent age of total formulation :
6. Proposed dosage :
(a) for adults.
(b) children by age group.
(c) infant
(d) special groups.

7. Main Pharmacological group to which the drug belongs:

8. Pharmacological and clinical data :
(a) recommended clinical use and the claims to be made for the drug.
(b) contra-indications.
(c) toxicity or the side-effects.
(d) any directions for the use to be included in the labelling, warning and precautions in use :
symptoms of over dosage should be given alongwith the treatment including antidotes, where
required.
9. Proposed route of administration.
10. Description of the method of manufacture and quality control with details of the
equipment.
11. Specifications, with details of analytical procedure for each ingredient and the finished
drugs (not required in case of a drug for which pharmacopocial standards recognised under the
Drugs Act, 1976, are claimed).
12. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form
Introducing first time in Pakistan).
13. Stability Summary :
(a) A complete description of and date derived from studies on the stability of new drug,
including information pertaining to the suitability of the analytical methods used
(b) Shelf-life when stored under expected or directed storage conditions.
(c) Recommended storage conditions and expiration date to be assigned to the specific
formulation and package..
(d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. (Such
observations should be utilized for appropriate labelled storage conditions or warning
statements).
(e) Type of container/package, with the nature of material, package testing (chemical,
mechanical, environmental).
14. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain
from counterfeiting shall also be submitted.
15. Pack size (s) and proposed maximum retail price with the following details:-
(i) Cost per retail pack of each active and non-active. Ingredients :
(ii) Cost of each packing material.
(iii) Cost of direct labour,
16. Justification : (Only in case of a new entity).
17. Patent number, if any, with date and its date of expiry.
18. In case of a new drug (entity) not yet registered in Pakistan :
(i) enclose certificate of registration and Free Sale from any of the following countries:
Japan, USA and European Company Member countries.
(ii) Any other relevant information that may be required by the Board for consideration of this
application.