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EMA and EU-Commission – Topical News

European Commission: Proposal for a Directive and Regulation amending provisions regarding information to the general public on medicinal products subject to medical prescription

RAin Dr. Brigitte Röhrig-Friese

Rechtsanwaltskanzlei Röhrig-Friese, Betzdorf/Sieg (Germany)

In its communication on safe, innovative and accessible medicines the objective of providing better information for patients on prescription-only medicinal products had been identified as one of the key issues. On December 10, 2008 the Commission had submitted 3 legislative proposals aiming at the realisation of these objectives for the pharmaceutical sector. On October 11 the Commission adopted the revised proposals taking into account the European Parliament’s proposals for amendment.
In the following, the content of the legislative proposal on the directive amending Directive 2001/83/EC1) (Community Code) and the regulation amending Regulation (EC) No. 726/20042) on the EMA and centralised procedure with respect to provisions governing advertising for prescription-only medicinal products will be described.