The decision of the United Kingdom to leave the EU has caused a high uncertainty throughout industry - and also in the pharmaceutical industry. The European QP Association has already received a number of questions on what Brexit actually means for QPs, for their memberships in the European QP Association or for issues like importation testing and certification. For that reason the EQPA leadership team has prepared some information:
Does the role of QP change?
We do not expect any change in the role of QP neither in EU nor in UK. For the time of negotiations (2 years after starting the process) we consider that full delegation of responsibilities amongst all QPs as described in the revised Annex 16 is ensured. Dependent of the outcome and legal construction established after 2 years delegation possibilities between QPs in the UK and EU/EEA may need to be re-assessed.
As the role of the QP is already enshrined in UK law, if the UK agrees to abide by EU legislation, there should be no change of the roles or responsibilities of the QP. However, after Brexit unless there is some sort of bilateral agreement it may not be possible for UK QPs to work in Europe, and vice-versa.
Does EU GMP continue to be applicable in UK?
We expect that for the time of negotiations of the Brexit all EU GMP rules and regulations continue to apply across EU and UK. Dependent of the outcome and legal construction established after 2 years GMP rules and regulations in UK may start to develop independently from EU GMP. As EU and UK are members of PIC/S and PIC/S GMP guidelines are mostly identical with EU GMPs, strong alignment of rules and regulations should continue after Brexit irrespective of the outcome and legal construction. After Brexit the UK could seek to join Norway, Liechtenstein and Iceland in the European Economic Area (EEA). If this was achieved then it is envisaged that little would change from the current situation.
Does a potential move of EMA impact QPs?
EMA is legally linked to EU not to UK. EMA will continue its work independent of a potential move. Applicability of centrally registered dossiers to UK will have to be re-assessed after finalization of the negotiations.
Does the Brexit have impact on requirements for importation testing?
We do not see any influence on the fulfilment of the requirements for importation testing for the time of negotiations if such testing is executed within EU or UK. Dependent of the outcome and legal construction established after Brexit possibilities to accept importation testing across EU and UK may need to be re-assessed. If after Brexit the UK can agree to an MRA or an ACAA with the EU, there will be no need for re-testing when product moves between the UK and the EU. Without an MRA or ACAA, the required re-testing will create significant additional work between the UK and the EU.
Does the Brexit mean that additional certification by a QP has to be performed after importation?
As already mentioned, we expect that for the time of negotiations of the Brexit all EU GMP rules and regulations continue to apply across EU and UK and neither re-testing nor re-certification has to be applied. Under a MRA the qualified person of the importer in the EU may be relieved of his responsibility to carry out the importation re-testing. However, actual MRAs are still requiring the EU GMP to perform a certification of the products after importation. Dependent of the outcome and legal construction established after Brexit possibilities to accept EU and UK QP certification and by that avoid unnecessary additional work with no added value to companies or patients may need to be re-assessed. It will be a challenge to industry but also to the EQPA to develop models how imports from UK to the EU and vice versa may get an exemption from re-certification and re-release procedures while maintaining safety of the products, by implementing possible safeguarding options to both protect the EU interests as well as UK.
Does the Brexit impact membership of UK QPs in the EQPA?
Even after a Brexit, full EQPA membership is possible if after Brexit the UK can agree to an MRA or an ACAA with the EU. The actual membership in the EQPA applies to you if you are either a registered (appointed or approved) QP in a EU member state, official EU member candidate or proposed candidate or you have a similar function (QP, Authorized Person or equal) in a country that has a MRA Agreement or an ACAA agreement with the EU in place (like, e.g., actually Switzerland or Israel).
This statement was prepared by the lead-team of the EQPA Interest Group (July 2016) an is also available on the QP Association website.