On 6 February 2014, the EMA released an amended Q&A document on the implementation of the new Variations Guidelines of 2013, which provides details on the different variation categories and the operation of procedures laid down in Commission Regulation 1234/2008 concerning the examination of variations to the terms of marketing authorizations for human and veterinary medicinal products.
In its press release, the EMA notes that the Q&A document has been amended in agreement with the European Commission and these amendments aim to clarify specific points related to the new (as of August 2013) variation categories to the terms of marketing authorizations. This concerns, in particular, category C.1. 11 on the introduction of, or changes to, the obligations and conditions of a marketing authorization (including the risk management place) and category C.1.13. on other variations not specifically covered by the Variations Guideline which involve the submission of studies to the competent authorities.
Continue Reading EMA clarifies interpretation of new variation categories in an amended Q&A document