EMA Clarifies Marketing Authorization Categories

The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013. The Commission guidelines on variations to marketing authorizations of medicinal products were amended in 2013. The revision of the variations guidelines was initiated by the pharmacovigilance legislation.

The following clarifications were made to the Q&A document:

• “The submission of pediatric studies under article 46 of the European pediatric regulation is to be handled as a post-authorization measure if the marketing-authorization 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-authorization 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 authorization holder to amend the due dates of the conditions of a marketing authorization or of measures in a risk management plan is to be handled as a type IB variation.”

• EMA will apply the changes, which concern centrally authorized products only, retrospectively from Jan. 1, 2014.