The European Medicines Agency (EMA) is reminding marketing-authorisation holders that they are advised to submit any quality type-IAIN and type-IA variations for 2013 by Friday 29 November wherever possible. This will enable the Agency to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2013 and 2 January 2014 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008External link icon.

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Marketing-authorisation holders intending to submit quality type-IB variations in December 2013 should liaise with the EMA prior to submission.  Type-I variations are minor changes to the marketing authorisation of a medicine.

 

  • Type-IAIN and -IA variations have no impact on the quality, safety or efficacy of the medicine. Type-IAIN variations must be notified to the national competent authority or the EMA immediately following implementation, in order to ensure the continuous supervision of the medicine. Type-IA variations do not require immediate notification and should be notified to the national competent authority or the EMA within 12 months of implementation, or earlier in certain cases.

 

  • Type-IB variations must be notified to the national competent authority or the EMA before implementation, but do not require a formal approval. Upon acknowledgement of receipt of a valid notification, the marketing-authorisation holder must wait for a period of 30 days to ensure that the notification is deemed acceptable by the national competent authority or the EMA before implementing the change.

 

Posted on the EMA website on 18 November 2013