Brexit and market release

Will release onto the Swiss market based on the EU Batch Release change after Brexit?

Up to now and based on the Mutual Recognition Agreement (MRA) with the EU, release onto the Swiss market based on the EU Batch Release was able to be done by the EU QP via the simplified procedure. The EU QP was able to be domiciled in any of the EU Member States (consequently, also in the UK). After Brexit, the UK (and the Medicines and Healthcare products Regulatory Agency, abbreviation: MHRA) will, however, no longer be a MRA partner, but will remain a PIC/S Participating Authority. For this reason, Brexit will not have a significant impact in relation to the GMP conformity of the manufacturing activities of manufacturers of approved products (incl. QC and technical batch release). As before, release onto the market will, however, have to be done by the SwissMarketing Authorisation holder’sResponsible Person.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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