Posted by Michael Wonder on 19 Jun 2018
Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
19 June 2018 - Publication of updated Q&As and practical guidance.
The EMA)and the European Commission have updated their guidance to help pharmaceutical companies prepare for the UK's withdrawal from the European Union.
Updates to the questions-and-answers document are marked ‘NEW’ and include information on how the UK’s withdrawal will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR). The document also clarifies how scientific opinions of the Committee for Medicinal Products for Human Use (CHMP) for ancillary medicinal substances in medical devices requested by UK notified bodies will be affected. In addition, it includes new information on back-up arrangements for Qualified Persons for Pharmacovigilance (QPPVs) and on marketing multi-country packs of medicines, where one of the countries in which the packs will be sold includes the UK.
