On 29 March 2017, the United
Kingdom (UK) decided to leave the European Union (EU) and the UK government
triggered Article 50 of the Treaty on the EU, officially starting the two-year
period of negotiation before the exist. The process, known as ‘Brexit’, will
presumably lead to profound changes to the broadly harmonised field of
medicinal products. At present, it is widely reported that the UK government
intends to pursue a ‘hard break’ from the EU, which would consider the UK
outside of the single market.
The European Medicines Agency (EMA)
and the European Commission have updated their guidance to help pharmaceutical
companies prepare for the United Kingdom’s (UK) withdrawal from the European
Union (EU).
Updates to the
questions-and-answers document 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.
The Agency has also published an
updated version of its practical guidance for industry which outlines the steps
that companies should follow to make sure that necessary changes to their
marketing authorisation are made by the end of March 2019, to allow for the
continued marketing of their medicine in the Union after Brexit.
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