3. — Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community…

3.

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products · European Union

If the person responsible for placing the medicinal product on the market proposes to make any alteration to the information and particulars referred to in Articles 6 and 9, he shall submit an application to the Agency.

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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.