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Batch Release Testing of Pharmaceuticals After Brexit

On 23 June 2016 the BREXIT referendum was held in which the UK voted to leave the EU.

What does this mean for the pharmaceutical industry? Currently testing of pharmaceuticals is given mutual recognition by each of the member states e.g. batch release testing in the UK is recognised across the EU as being performed in accordance with the required quality standards of each of the member states.

On 29 March 2017, the two year process of leaving the EU was triggered, posing the question  -  will there still be mutual recognition of pharmaceutical testing in March 2019?

The European Medicines Agency (EMA) in May 2017, to give some clarity on the position, published a paper entitled:

Questions and Answers related to the UK’s withdrawal from the EU with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure

https://ec.europa.eu/health/sites/health/files/files/documents/qa_on_brexit.pdf

If no agreement is reached and the UK becomes a “Third Country” then to sell pharmaceuticals in the EU:

  1. The marketing authorisation holder must be established in the EU.
  2. For designated orphan medicinal products the holder will therefore need to transfer its designation to a holder established in the EU.
  3. For veterinary medicines (Minor Use Minor Species/limited market) if the sponsor/applicant is established in the UK, the MUMS incentives would no longer be applicable.
  4. The qualified person responsible for pharmacovigilance must reside and carry out his/her tasks in the Member State of the EU.
  5. Pharmacovigilance System Master File must be locked in the EU.
  6. Active substances manufactured in the UK will be considered imported active substances.
  7. Medicinal products manufactured in the UK will be considered imported medicinal products.
  8. As such batch release testing will need to be performed in the EU. For centrally authorised medicinal products the marketing authorisation holder will need to transfer its current UK based site of batch release to a location established in the EU.

As such the converse will apply to any pharmaceutical company wanting to release products or operate in the UK.

Therefore, with less than 18 months to go before March 2019 and to enable pharmaceutical companies to continue to supply the UK market place, it is time to select and establish a relationship with a trusted Contract Research Organisation (CRO), such as Source BioScience

Source BioScience is a leading independent, MHRA approved (cGMP) CRO specialising in the provision of chemistry, manufacturing and control (CMC) laboratory services for all phases of drug development. We support the pharmaceutical research and development process from preclinical enabling studies for investigational medical products (IMPs), through the clinical research phases to batch release testing into the market place.

Our pharmaceutical chemistry and microbiology departments are among the finest equipped and most professional contract testing facilities in Europe. Quality is paramount for the high technology delivery system, whether it is developing and validating methods for novel pharmaceuticals or delivering routine Pharmacopoeia testing on API’s, raw materials, excipients and formulations. With fast on time delivery of projects Source BioScience works in partnership with its customers to ensure they meet their business objectives.


Stewart Neithercut
Head of Sales – Analytical Chemistry
For further information and prices please email or call +44 (0)115 973 9012

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