Regulatory information - EMA clarifies interpretation of new variation classification categories
The European Medicines Agency has clarified, in agreement with the European Commission, a number of points related to the new categories of variations to the terms of marketing authorisations that were introduced in August 2013. The related question and answer document has been updated to reflect these adjustments.
The Commission guidelines on variations to marketing authorisations of medicinal products were amended in 2013. The revision of the variations guidelines was principally triggered by the implementation of the pharmacovigilance legislation.
In the light of experience accumulated with the application of the new guidelines, it is appropriate to make the following clarifications:
- the submission of paediatric studies under article 46 of the European paediatric regulation is to be handled as a post-authorisation measure if the marketing-auhtorisation holder confirms that they deem no changes to the product information necessary; an implementing variation category C.1.3 is triggered only when amendments to the product information are identified following assessment by the Agency’s Committee for Medicinal Products for Human Use (CHMP). In cases where the marketing-auhtorisation holder identifies the need to update the product information based on the data of the P46 study at the time of submission, a variation category C.1.4 needs to be applied for;
- the submission of environmental risk assessment (ERA) for medicines for human use will be handled as type IB variations and not as type II variations since these reports do not contain information affecting the quality, safety and efficacy of the medicines;
- the request by a marketing authorisation holder to amend the due dates of the conditions of a marketing authorisation or of measures in a risk management plan is to be handled as a type IB variation.
These adjustments will be applied retrospectively by the Agency from 1 January 2014. They concern centrally authorised products only.
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- New variations regulation: Regulatory and procedural guidance
- 2010 pharmacovigilance legislation
- European Commission: EudraLex - Volume 2