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B.8 Variations to the Terms of a Marketing Authorisation
B.8.1 Classification of Variations
B.8.1.1 Minor Variation of Type IA and IB
B.8.1.2 Major Variation of Type II
B.8.1.3 Extension Applications
B.8.1.4 Urgent Safety Restrictions
B.8.2 Grouping of Variations
B.8.3 Worksharing Procedure
B.8.4 Application Form for a Variation to a Marketing Authorisation
B.8.5 Variations - Guidelines and References

Review of the Regulatory Framework on Variations
Oct. 12, 2009

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.

B.1.1.1 Legally Binding Pharmaceutical Legislation and Soft Law
D.3 Advanced Therapy Medicinal Products
D.3.7 ATMPs - Dossier Requirements in Directive 2009/120/EC

Implementation of Advanced Therapies Regulation
Oct. 07, 2009

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.

A.3.6 Scientific Advice
A. Fees Payable to the EMA

Adaptation of Fees payable to the EMEA to the Inflation Rate
Jun. 24, 2009
Council Regulation (EC) No. 297/95 on fees payable to the EMEA must regularly be updated to adapt the fees payable to the inflation rate. The most recent adaptation has been made by Commission Regulation (EC) No. 249/2009. The respective chapters A 3.6 and A dealing with fees payable to the EMEA have been updated accordingly.


CAT included in the description of Scientific Committees
Jun. 08, 2009
In the course of a regular update, Chapter A has been added, containing the description of the Committee for Advanced Therapies. Legal basis, composition and tasks of the Committee are dealt with.