The MHRA has recently published a guidance for handling of centrally authorised products (CAPs) with assessment pending on EU exit day. Although the document is concerned with a no-deal scenario, it may also provide an accurate framework in the event of an ordered Brexit, depending on the exact...
Read moreBREXIT: Procedural Updates for Type I EMA variations The EMA is strongly encouraging MAHs to be prepared for Brexit to occur by the 12th of April 2019. In particular, the Agency is requesting that Type I variations are submitted ASAP in order to guarantee that they are validated on time, as the...
Read moreWebinar: EU Labelling Requirements The EUDRAC team is presenting a TOPRA webinar on the linguistic review process at the end of March. We will share learning from our experience and also seek to impress upon attendees the high level of specialism that we have achieved from our work in the area. The...
Read moreWithdrawal of the United Kingdom and EU rules for batch testing of medicinal products: Communication from the European Commission (February 2019) The European Commission has recently released a communication providing guidance on possible request for exemption regarding quality control testing...
Read moreOptimising Orphan Drug Development in the EU - DIA Europe 2019 update EUDRAC exhibited at the annual DIA Europe Meeting in Vienna, Austria from 5th - 7th February 2019. A session was held on ‘Optimising Orphan Drug Development in the EU’ and below are some highlights of the discussions. EU Figures...
Read moreGuidance is Relevant to DCP/MRP/National Marketing Authorisations CMDh has issued an updated Questions and Answers document regarding Brexit for how Marketing Authorisation activities will proceed in the event of no withdrawal agreement and hence without a transition period. http://www.hma.eu/...
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