Article 3

1. No medicinal product referred to in Part A of the Annex may be placed on the market within the Community unless a marketing authorization has been granted by the Community in accordance with the provisions of this Regulation. 2. The person responsible for placing on the market a medicinal product referred to in Part B of the Annex may request that authorization to place the medicinal product on the market be granted by the Community in accordance with the provisions of this Regulation. 3. Before entry into force of this Regulation and after consultation of the Committee for Proprietary Medicinal Products, Parts A and B of the Annex as regards medicinal products for human use shall be re-examined in the light of scientific and technical progress with a view to making any amendments necessary which will be adopted under the procedure laid down in Article 72. 4. Before entry into force of this Regulation and after consultation of the Committee for Veterinary Medicinal Products, Parts A and B of the Annex as regards veterinary medicinal products shall be re-examined in the light of scientific and technical progress with a view to making any amendments necessary which will be adopted under the procedure laid down in Article 72. 5. The procedures referred to in paragraphs 3 and 4 shall continue to apply after entry into force of this Regulation.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.