Statutory Instruments

The Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) (No. 2) Regulations 2009

The main purpose of these Regulations is to facilitate the operation of Commission Regulation (EC) No. 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for
human use and Directive 2009/35/EC of the European Parliament and Council on the colouring matters which may be added to medicinal products

Regulation 1234/2008 has been adopted to simplify, update and improve the current rules with regard to all variations to Marketing Authorisations and to ensure that all Marketing Authorisations for medicinal products are subject to the same variations procedures

Directive 2009/35/EC recasts Council Directive 78/25/EC on the colouring matters which may be added to medicinal products. The purpose of this Directive is to remove disparities in national legislation regarding the colouring of medicines across EU Member States

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