Variations
For medicinal products with a European marketing authorisation (mutual recognition or decentralised or centralised procedure), applications for variation should be submitted to all concerned Member States (CMS), in accordance with Commission Regulation (EC) 1234/2008.
Minor changes are referred to as Type IA or Type IB variations, while major changes can be submitted as Type II variations or Extension Applications. The competent authority (CA) of the Reference Member State (RMS) will start the procedure once identical applications have been submitted to all CMS. For a Type II application the RMS prepares an Assessment Report. If a CMS expresses disagreement with it, the applicant is given a chance to resolve the controversial issues. If no CMS has expressed disagreement the Type II variation is accepted. Type IA variations are to be reviewed for validation within 30 days. Type IB variations are considered accepted unless the RMS has sent an unfavourable opinion to the marketing authorisation holder (MAH) within 30 days following the acknowledgement of receipt of a valid notification.
Pursuant to Art. 8 sub-section 1 sentence 2 of Council Regulation (EU) No 1234/2008, a prerequisite for a Type IA Variation is that the notification of the implementation thereof to the competent authority is made within 12 months after its implementation. If the competent authority is notified at a later time, the conditions for a Type IA Variation are no longer fulfilled. Type IA Variations that are not submitted to the BfArM within the 12 month period in accordance with Art. 8 sub-section 1 sentence 2 of Council Regulation (EU) No 1234/2008 will be refused as invalid. These variations are then to be submitted as Type IB variations by default in the same category.
… References to the submission of variations
The Federal Institute for Drugs and Medical Devices publishes FAQ on variations, especially regarding the implementation of the Variation Regulation for purely national licences on 4 August 2013.
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