LAW No.

491 of November 18th, 2003 of the medicinal and aromatic plants ISSUED BY: The Parliament of Romania PUBLISHED IN: the Official Gazette of Romania November 26th, 2003 Data intrarii in vigoare : 29 noiembrie 2003

Part I, No. 844 of

_________ Note C.T.C.E.: For using in court, only the text in the Romanian language has legal foundation. The Romanian Parliament adopts the following law. ART. 1 The present law establishes the general frame regarding production, processing and organization of the medicinal and aromatic plants market, relationships between manufacturers, processors and merchants. (2) For the purpose of the present law, the following terms are defined as such: a) production represents obtaining by cultivation or harvesting from spontaneous flora of medicinal and aromatic plants; b) remaking represents the conditioning of medicinal and aromatic plants in: teas, natural condiments as well as in raw materials for processing; c) processing represents the transformation of raw materials obtained by remaking in products, which are marketed: medicinal products, cosmetics, nutritive and dietetic supplements, foodaromatizing additives; d) the manufacturer is the physical or juridical person who cultivates medicinal and aromatic plants; e) the collector is the physical or juridical person who collects medicinal and aromatic plants from spontaneous flora; f) the processor is the physical or juridical person who processes the medicinal and aromatic plants for obtaining finished products for being marketed; g) medicinal and aromatic plants are plants from the catalog and nomenclature of medicinal and aromatic plants from the culture and spontaneous flora or from the official communitary catalogue or of an European Union Member State; (3) The national catalog and nomenclature of medicinal and aromatic plants from the culture and spontaneous flora is approved by Order of the Minister of Agriculture, Forests, Waters and Medium. ART. 2 For the purpose of this law, the authority of central public administration in the domain of medicinal and aromatic plants is

the Ministry of Agriculture, Forests, Waters and Medium, named as Competent Authority. ART. 3 (1) For medicinal and aromatic plants which are marketed fresh and processed, technical norms for manufacturing and marketing are established. The technical norms for manufacturing and marketing of medicinal and aromatic plants are elaborated by the Ministry of Agriculture, Forests, Waters and Medium and Ministry of Health and are approved by common Order of the Minister of Agriculture, Forests, Waters and Medium and Minister of Health. (2) For establishing technical norms for manufacturing and marketing of medicinal and aromatic plants, the provisions of the Guideline for good practice for cultivation of medicinal and aromatic plants and of the Guideline for good harvesting practice for cultivation of medicinal and aromatic plants from the spontaneous flora are considered. (3) The Guideline for good practice for cultivation of medicinal and aromatic plants and the Guideline for good harvesting practice for cultivation of medicinal and aromatic plants from the spontaneous flora are approved by Order of the Minister of Agriculture, Forests, Waters and Medium. (4) The medicinal and aromatic plants designated for being marketed fresh and processed, can be introduced on the market if they are conformed to the technical norms for manufacturing and marketing. (5) The products obtained from processing the medicinal and aromatic plants and having therapeutical indications are framed as medicinal products and are authorized for marketing by the National Medicines Agency. (6) The surveillance on the market of the products mentioned at paragraph (5) is realized by the inspectors of the General Pharmaceutical Direction, Pharmaceutical Inspection and Medical Equipment of the Ministry of Health and by inspectors of the National Medicines Agency. (7) The surveillance on the market for the other products mentioned at Art. (4) is done by the inspectors of the Ministry of Agriculture, Forests, Waters and Medium and of the Ministry of Health as well as by authorized persons from the National Authority for Consumer Protection. ART. 4 The conformity with the technical norms for manufacturing and marketing of medicinal and aromatic plants fresh or processed, is established in accordance with the law by certified organisms accredited for this purpose. ART. 5 For being marketed, the medicinal and aromatic plants are subject to certification procedure. ART. 6 (1) An Inter-Ministry Technical Committee of Medicinal and Aromatic Plants, formed by 7-9 persons, researchers and didactic persons, experts in the field, which examines the problems

related to the functioning of the medicinal and aromatic plants market and emits technical decisions is established. (2) The structure, organization, functioning and place of conducting the activity of the Inter-Ministry Technical Committee of Medicinal and Aromatic Plants is approved by common Order of the Minister of Agriculture, Forests, Waters and Medium, Minister of Health and Minister of Economy and Commerce. ART. 7 (1) For the purpose of developing the sector and for valuing the resources from the field of medicinal and aromatic plants, the Inter-Ministry Technical Committee of Medicinal and Aromatic Plants elaborates programs regarding the production, processing and promotion of medicinal and aromatic plants for periods of one to three years. (2) The agricultural manufacturers, medicinal and aromatic plants cultivators benefit from the provisions of the Government Emergency Ordinance No. 108/2001 regarding agricultural exploitation approved with changes and completions by Law No. 166/2002. ART. 8 The Competent Authority establishes yearly the list with the name of the programs stipulated at art. 7, paragraph (1) and keeps the evidence of the national interest programs. ART. 9 The Ministry of Agriculture, Forests, Waters and Medium, Ministry of Health and Ministry of Economy and Commerce, together with the Inter-Ministry Technical Committee of Medicinal and Aromatic Plants and the Council per Product, establish the National Strategy of the medicinal and aromatic plants sector which is approved by Government decision. ART. 10 (1) Between agricultural manufacturers and/or medicinal and aromatic plants collectors on one hand and by merchants and/or processor on the other hand, contracts are established. (2) The contracts mentioned at paragraph (1) are registered for statistical purpose at the Competent Authority. ART. 11 (1) The agricultural manufacturers of medicinal and aromatic plants have the obligation to declare yearly the effective cultivated surface, per species and realized delivers. (2) The declarations are registered at the Directions for Agriculture and Rural Development of the counties and of Bucharest. (3) The centralized situation of these registrations is sent to the Ministry of Agriculture, Forests, Waters and Medium. ART. 12 The medicinal and aromatic plants, fresh or processed, which come from the European Union, legally produced, can be marketed on Romanian territory if they fulfill the conditions established by the legal national regulations in the respective field. ART. 13

Within 90 days from the date of entering into force of the present Law, the Ministry of Agriculture, Forests, Waters and Medium, with the consultation of the Council per Product, emits the Orders mentioned at art. 1 paragraph (3) and art. 3 paragraph (3) and together with the Ministry of Health and Ministry of Economy and Commerce elaborate the common Orders mentioned at art. 3 paragraph (1) and art. 6 paragraph (2). Senate has adopted this law in the meeting on 8 September 2003, by respecting the provisions of art. 74, paragraph (2) from the Romanian Constitution. p. President of the Senate DAN MIRCEA POPESCU Deputies Chamber has adopted this law in the meeting on 4 November 2003, by respecting the provisions of art. 76, paragraph (2) from the republished Romanian Constitution. p. President of Chamber of Deputies VALER DORNEANU Bucharest, 18 November 2003 No. 491 ----