Pharmaceutical manufacturers and importers are being urged to register promptly with SecurMed UK, the UK medicines verification organisation, to ensure that the UK pharmaceutical industry is ready for the introduction of the Falsified Medicines Directive (FMD) on 9 February 2019.
Under the FMD, manufacturers are required to fund the setup and management of the national medicines verification organisations. UK-based marketing authorisation or parallel import licence holders must register with SecurMed UK and pay setup fees of £35,000.
In a letter sent to these pharmaceutical companies on 19 April 2018, Jerome Bertin, general manager of SecurMed UK, told manufacturers of a sliding scale of significant discounts in set-up fees for companies who pay early. Those paying before 31 May 2018 will receive a 52% discount on the set-up fee, paying only £17,000, and will also receive 20% discount on annual operation fees for the first two years from February 2019.
No discounts will be available for those who pay on or after February 2019.
Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry and a director of SecurMed, said it was “critical in the interests of patient safety and the uninterrupted supply of medicines that marketing authorisation holders register with SecurMed and pay the initial set-up fee”.
SecurMed also shared a letter from Lord O’Shaughnessy, parliamentary undersecretary of state for health, to Warwick Smith, chair of SecurMed, in which Lord O’Shaughnessy confirmed that under the EU Withdrawal Bill, the FMD will, unless “specifically revoked”, continue to apply in the UK post-Brexit.