Potential Procedural Efficiencies and Challenges of Combining Multiple Type II Variations into a Single EU-RMP

The process for amending a European Union Risk Management Plan (EU-RMP) with new information requires the submission of a formal variation procedure, of which there are four distinct categories: Type IA, Type IB, Type II, and 'Extension of a marketing authorisation' (or simply 'extension'). A Type II variation, in accordance with the above-referenced European Commission regulation, is defined as 'a variation that is not an extension of the marketing authorisation (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product'. Additional detail regarding which type of variation should be submitted in specific circumstances is provided in the accompanying guideline. Common working practice for submission strategies when managing multiple Type II variations has been to either submit each in sequence or submit several parallel procedures each with its own corresponding EU-RMP. Submitting in sequence results in a prolonged, end-to-end process with each procedure resulting in a new, iterative version of the EU-RMP. Alternatively, submitting multiple parallel variations with their own corresponding EU-RMPs can result in very complicated procedural wrap-up activities and very short-lived approved versions. In this article, we describe an approach to the management of multiple Type II variations, which is now in line with the recently revised European Medicines Agency (EMA) frequently asked questions (FAQ) guidance on how to manage grouped Type II variation applications, whereby four parallel Type II variation procedures were successfully initiated simultaneously with a single EU-RMP.