laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
The purpose of this Regulation is to lay down Community procedures for the authorisation, supervision and phar- macovigilance of medicinal products for human and veterinary use, and to establish a European Medicines Agency (hereinafter referred to as ‘the Agency’).
1. No medicinal product appearing in the Annex may be placed on the market within the Community unless a marketing authorisation has been granted by the Community in accordance with the provisions of this Regulation. The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular,
Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indi- cations and pack sizes which will be covered by their social security bodies. Read more ...


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