The European Commission has released a question and answer document on medicinal products relating to the United Kingdom’s withdrawal from the European Union. The document answers questions relating to marketing authorisation holders, orphan designations, manufacturing sites and pharmacovigilance in the UK. Unless the withdrawal period is extended, then in accordance with Article 50(3) of the Treaty on European Union, all Union primary and secondary law ceases to apply to the UK from 30 March 2019. The UK will then become a ‘third country’, meaning that it will no longer be regulated under the laws that govern the EEA and will need to meet certain criteria to be able to export medicines to the EEA.
Key changes include:
- Marketing authorisation holders, and orphan designation holders based in the UK will likely need to transfer their marketing authorisation to a holder established in the Union (EEA)
- For pharmacovigilance activities, the Qualified Persons for Pharmacovigilance (QPPV), may need to change his/her place of residence and carry out his/her tasks in the Union (EEA), or a new QPPV residing and carrying out his/her tasks in the Union (EEA) will need to be appointed
- Pharmacovigilance System Master Files (PSMF) based in the UK will also need to be relocated, and the marketing authorisation holder will therefore need to change the location of the PSMF to a Member State within the Union (EEA)
- As of the date of the withdrawal of the UK from the Union, active substances manufactured in the UK will be considered imported active substances. These active substances will require written confirmation from the competent authority of the exporting third country confirming that the standards of good manufacturing practice (GMP) and control of the plant are equivalent to those in the Union (EEA).
- If the finished product is manufactured in the UK, the import of medicinal products into their territory is subject to an authorisation in accordance with Article 40(3) of Directive 2001/83/EC and Article 44(3) Of Directive 2001/82/EC. This means that a number of criteria must be met, such as the availability of a qualified person within the Union (EEA) and a GMP inspection.
- If the batch release base for a product is in the UK, the marketing authorisation holder will need to transfer its current UK based site of batch release to a location established in the Union (EEA).
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