News & events

How to comply: Falsified Medicine Directive

29.01.2018

Preparing for the final phase of the Falsified Medicine Directive

What is the Falsified Medicines Directive?

The European Union (EU) are continuously working to combat the threat of counterfeit or ‘falsified medicines’. Since 2011, the European Commission (EC) has been working on amending and improving the Falsified Medicines Directive (FMD), the final phase of which will be rolled out in February 2019.1

Raj Patel, Chair of the UK FMD Working Group for Community Pharmacy, says: ‘Falsification of medicines is a major threat to patient safety and cases of falsification continue to be discovered by authorities. FMD aims to reduce this by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process.’2

How will it affect pharmacies?

The majority of changes will happen within manufacturers who will be required to add safety features to each pack of medicine. Pharmacies will be responsible for checking packs as they receive the stock or before the medicine is dispensed. Here are the key safety features that will be added ready for 9th February 2019:

  • A unique identifier (a 2D data matrix code and human readable information) to be placed on medical products that can be scanned at fixed points along the supply chain
  • Tamper evident features on the pack (ATD)3

Furthermore, when a pharmacy scans a pack, if it hasn‘t been registered or has been decommissioned, a warning alert will be issued advising the pharmacy not to supply. All prescription medicines will require a barcode* to be scanned, however over the counter (OTC) medicines will only need to be scanned if proof of counterfeiting has been evidenced.

How will it be managed?

Everyone within the supply chain will be affected (in some way) as everyone will have to adhere to the new legislation. The barcode information will be held and managed by the European Medicines Verification Organisation (EMVO) with help on a nationwide level from UK Medicines Verification Organisation (UKMVO). Manufacturers will be responsible for adding packs into the database while pharmacies will be accountable for authenticating and decommissioning.


*There are a few exceptions which will appear in a white list that will be held and monitored by the MHRA.


References

  1. What is the Falsified Medicines Directive? [online] Viewed January 2018 https://www.pharmaceutical-journal.com/your-rps/what-is-the-falsified-medicines-directive/20201820.article
  2. Making sense of the Falsified Medicines Directive ‐ new information hub for pharmacies [online] Viewed January 2018 https://www.npa.co.uk/news-and-events/news-item/making-sense-falsified-medicines-directive-new-information-hub-pharmacies/
  3. New rules to help fight falsified medicines [online] Viewed January 2018 https://www.gov.uk/government/news/new-rules-to-help-fight-falsified-medicines
  4. Falsified Medicines Directive (FMD) [online] Viewed January 2018 https://psnc.org.uk/contract-it/pharmacy-regulation/falsified-medicines-directive/
  5. The UK FMD Working Group for Community Pharmacy [online] Viewed January 2018 https://ukfmdworkinggroup.wordpress.com/