Webinar: 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/...
Read moreDIA 2019 Vienna EUDRAC will be exhibiting at the annual DIA Europe Meeting in Vienna, Austria from 5th - 7th February 2019. Our team would be pleased to welcome you at booth number B70 to discuss your potential regulatory affairs, pharmacovigilance and publishing needs. A member of our Management...
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...
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