Written by: Anne Marie Gaffney
Do you have an EU QPPV based in the UK? Do you export pharmaceutical finished product or active substance from UK to European countries? Is your batch release site located in the UK? If yes, then it’s time to take note: Brexit is coming and the reality of the UK leaving the EU is coming into focus for the pharmaceutical industry. The EMA have just released a series of Questions and Answers providing some more clarity on implications.
Unless the withdrawal agreement is extended, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019. The United Kingdom will then become a ‘third country’.
The first notice was published on 2 May 2017, from EMA and the European Commission to marketing authorisation holders of centrally authorised medicines. The intention of the notice was to remind them of their legal obligations in preparation for Brexit.
- EU law requires that marketing authorisation holders are established in the EU (or EEA);
- Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.
On 1st June, the EMA released another regulatory update in response to some frequently asked questions about the impact of the UK leaving the EU. This update sets the tone for what is coming down the tracks.
The document clearly spells out that preparing for the consequences of the UK’s withdrawal from the Union is not just a matter for European and national administrations, but also for private parties.
The following is a summary of implications addressed in the Q&A
- For MAH (market authorisation holder) or orphan designation holder established in the UK, the Q&A clearly spells out the holders must be established in the Union.
- Qualified Persons for Pharmacovigilance(QPPV) must reside and carry out tasks in the Union.
- The location of the Pharmacovigilance System Master File must be located in the Union.
- The location of batch release site must be located within the Union.
- Manufacturing sites of active substances and finished products located in UK will be considered imported active substances and finished products into the EU and as such will be subject to import legislation.
- The issue of access to financial and administrative assistance in accordance with ‘the SME regulation’ is addressed. In order to be eligible, companies must be established in the Union and meet the definition of an SME.
The full Q&A document can be viewed on this link.: