As part of the Commissions initiative to a ‚Better Regulation of Pharmaceuticals the review of the regulatory framework on variations has been started in a 3-steps-approach.

By now, two steps were finalized:

• Step 1: Review of the content of the current Variations Regulations (1084/2033; 1085/2003) (comitology) by adoption Variations Regulation 1234/2008
• Step 2: Change to the legal basis of the Variations Regulation (co-decision) by adopting Directive 2009/53/EC amending Directives  2001/82/EC and 2001/83/EC

The last major Step (3) needs still to be taken: Updating the Variations Regulation to include Purely national marketing authorisations (comitology).

As a consequence, the revised regulatory framework for variations will apply from 01 January 2010 for medicinal products granted under MRP/DCP and the Centralised Procedure.

The GtDRA chapter B.8 have been updated accordingly.

ATMPs - Commission Directive 2009/120/EC replaces Part IV of Annex I to Dir 2001/83/EC

Commission Directive 2009/120/EC of 14 September amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products.

For updates and further information see GtDRA chapter D3 Advanced Therapy Medicinal Products.