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Focus on Regulation

EMA warns marketing authorisations holders to notify type I variations earlier

On 26 October 2018, the European Medicines Agency (EMA), advised marketing authorisation holders to submit type I variations prior to the temporary closure of the EMA. The EMA will relocate from London to Amsterdam and will be closed between 21 December and 2 January 2019.

Article 14 Commission Regulation No 1234/2008 provides that the EMA has 30 days to react to the submission of type I variations. In order for marketing authorisation holders to receive a reaction within this 30 day time period, the EMA advises that submissions be made by the following dates:

  • Type IAIN and IA variations: 30 November 2018
  • Type IB or groupings of IBs and IAs: 7 December 2018

Any submission received on or after 10 December 2018, will be not be processed until January 2019.

Type I variations are minor changes to the marketing authorisation of a medicinal product that have minimal or no impact on the quality, safety or efficacy of the medicinal product. There are two types of variations, variation IA and variation IB. Variation IA has a subcategory IAIN.

Type IA variations do not require an immediate notification to the EMA or the national competent authority. Type IA variations do not, moreover, require approval before implementation by the marketing authorisation. They should, however be notified to the EMA or the national competent authority within 12 months of implementation.

IAIN variations require immediate notification to the EMA or to the national competent authority after the change to the marketing authorisation. The British national competent authority (MHRA) interprets “immediate” as within two weeks after the implementation of the change to the marketing authorisation. A marketing authorisation variation can be an IAIN variation if the variation interferes with the EMA’s or national competent authority’s ability to continuously supervise the product.

Type IB variations are variations to a marketing authorisation that must be notified to the EMA or the national competent authority before the implementation of the changes. The marketing authorisation holder must wait for a period of 30 days before implementing the changes to the marketing authorisation. The EMA or national competent authority may object to the changes to the marketing authorisation during this period.