BREXIT: 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 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 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/...
Read moreNew MHRA Guidance following a ‘hard’ Brexit On January 3rd the MHRA issued its updated guidance on the regulation of medicines, medical devices and clinical trials in the event of a no-deal Brexit. In this scenario the MHRA would regain sole responsibility for all regulatory activities currently...
Read moreBrexit implementation period The MHRA has recently updated its information on the implications of Brexit, in particular on the terms that will be agreed for the implementation period: Market Access for Medicinal Products Manufacturing and distribution licences will continue to be recognised by the...
Read moreEvery day there are articles and bulletins about BREXIT in the news. So far, nothing has been finalised, however the regulators continue to meet to discuss future arrangements. EUDRAC is closely following these discussions and is attending key meetings with regulatory agencies. With tightly...
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