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Focus on Regulation


On 10 February 2014, the European Medicines Agency (“EMA”) published a revised Questions & Answers document. The document supports the implementation of the European Commission Guidelines on the details of the various categories of variations (“Variations Guidelines“). The aim of the document is to address questions that marketing authorisation holders may have in relation to the new categories of variations to the terms of marketing authorisations for centrally authorised medicinal products, and the manner in which the new categories of variations are handled by the EMA in practice.

Following consultation with the EU Member States and the EMA, the Variations Guidelines were published by the European Commission on 2 August 2013, in order to facilitate the application of the EU Variations Regulation. These Variations Guidelines are regularly updated to reflect recent amendments to EU legislation, including amendments to the Variations Regulation and the new Pharmacovigilance rules. For more information on the new amendments to the EU pharmacovigilance rules, please see our earlier update.

The revised EMA Questions & Answers document seeks to addresses specific practical questions related to the new categories of variations which were introduced to the Variations Guidelines in August 2013. These include, in particular:

  • The submission of paediatric studies related to the paediatric population in accordance with Article 46 of the EU Paediatric Regulation should continue to follow the procedure for post-authorisation measures unless the marketing authorisation holder concludes that changes to the product information are necessary based on the study data submitted.  If, therefore, the marketing authorisation holder deems it necessary to update the product information based on the paediatric studies, the marketing authorisation holder must apply for a variation under category C.1.4.
  • Marketing authorisation holders must apply for a type IB variation for studies in the context of an environmental risk assessment (ERA) for medicines for human use since these study reports do not contain any information which would affect the quality, safety and efficacy of the medicinal product.
  • A request by a marketing authorisation holder to amend the date for which the conditions of a marketing authorisation or of measures in a risk management plan must be performed, should be submitted as a type IB variation.

According to the EMA press release, the provisions which concern the new categories of variations will apply retrospectively from 1 January 2014. Marketing authorisation holders should, therefore, ensure that any applications for variation submitted from 1 January 2014 take into account the new provisions in the EMA Questions & Answers document.