EU ministers approve simpler legislation for supplementary protection certificates

Published: 26-May-2009

The EU Council of Ministers has approved a simplified and codified piece of legislation helping pharmaceutical manufacturers understand their EU rights regarding supplementary protection certificates.


The EU Council of Ministers has approved a simplified and codified piece of legislation helping pharmaceutical manufacturers understand their EU rights regarding supplementary protection certificates.

This is in line with the legislative rationalisation policy of the current European Commission, which has wanted to ease understanding of often complex EU laws. These are particularly confusing when amended many times, forcing companies to constantly refer back to the original legislation and assess later changes.

In this instance, EU ministers have approved a new codified regulation on supplementary certificates that rolls all previous laws on the topic into one. It subsumes regulations (EEC) No 1768/92 of 1992; (EC) No 1901/2006 of 2006; and three acts of accession, by which the EU approved the admission of new member states - authorised in 1994, 2003 and 2005.

A Commission note stressed it "attaches great importance to simplifying and clarifying [EU] law.. to make it clearer and more accessible..".

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