Brexit readiness: what’s your EU QP and batch release site strategy?

Brexit readiness: what’s your EU QP and batch release site strategy?

In March 2017, the UK notified the European Council of its intention to withdraw from the EU. Since announcing its intention to leave, the UK has entered talks with the EU to determine the terms of their new relationship.

At MIAS Pharma, we have seen a significant increase in requests from clients who require our support in ensuring that supply of their medicinal products across Europe continues without disruption after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe provided in Article 50 of the Treaty on European Union.

Following Brexit, QP batch release will need to be performed within the EU for EU markets under a manufacturer’s/importer’s authorisation (MIA) that is held by a legal entity with the EU. A large number of companies are choosing to relocate the responsibility for EU batch certification of medicinal products from the UK to Ireland.

For smaller companies who are not in a position to set up an Irish operation and obtain an MIA in Ireland, the preferred approach is to contract another MIA holder (such as MIAS Pharma) to perform the batch certification on their behalf.

MIAS Pharma is based in Dublin, Ireland and we currently hold two MIA licences; one for QP release of commercial product and one for QP release of IMPs. MIAS Pharma can be the registered batch release site for clients who wish to change their EU batch release site from the UK to Ireland in one of two ways:

 1.Add the client’s products to the MIAS Pharma licence for batch certification by one of our in-house QPs:
  • Our QPs will complete extensive training specific to a client’s products before submitting a variation to the HPRA (Ireland’s regulatory authority) to add these products to the MIAS Pharma MIA.
  • Upon variation approval by the HPRA, EU batch certification can be performed by MIAS Pharma on behalf of a client.
2. Add the client’s products and client’s QP(s) to the MIAS licence for batch certification in the EU:
  • Some clients may prefer to continue to use their currently UK-registered QP(s).
  • In this case, the QP would complete training on the MIAS Pharmaceutical Quality system, before variation submission to the HPRA to be added as a named QP on the MIAS Pharma licence.
  • The QP does not need to be an Irish resident as the EU directives don’t include this requirement and the HPRA does not have a national policy setting a requirement for residency. However, the batch certification should take place at the MIAS Pharma premises as this is a prescribed activity and under Irish law must take place at the premises detailed on the MIA.
  • The educational qualifications of a QP would be accepted by the HPRA if they had been named on a UK MIA. Separate assessment would be undertaken of their experience in relation to the dosage forms to be certified.
  • Upon variation approval by the HPRA, EU batch certification can be performed by the client’s QP(s) at MIAS Pharma’s premises in Ireland under our MIA.
The MAH can subsequently submit a variation for the change of batch release site from the UK site to MIAS Pharma.

If you would like to discuss your specific requirements relating to Brexit readiness and how MIAS Pharma can help you execute your EU batch release strategy, get in touch with us at +353 (1) 846 3605 or info@miaspharma.com.