Els Janssens


The MHRA published guidance on 12 March on QPPVs, PSMFs and MHRA PV registration in the event of no deal, aimed at providing practical information and instructions to UK MAHs on the role and responsibilities of the UK QPPV, the development and registration of the UK PSMF and the notification…

In accordance with Article 114 of Directive 2001/83/EC, Member States have the right to require the marketing authorisation holder (MAH) of a human immunological medicinal product or a medicinal product derived from human blood or plasma to submit samples from each batch for examination by an Official Medicines Control Laboratory (OMCL) or a laboratory that a Member State has designated for that purpose before the market release.

Such right exists unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications.

In the UK, independent certification under article 114 is carried out by the National Institute for Biological Standards and Control (NIBSC).

On February 19, 2019, the NIBSC issued guidance for manufacturers to clarify what happens in case of a no deal Brexit.