On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EMA CLARIFIES NEW VARIATION CLASSIFICATION CATEGORIES
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.
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