EU Falsified Medicines Directive (2011/62/EU)
Medicinal Product Safety Features and FAQ
We would like to communicate our readiness for compliance to the above delegated regulation (EU) 2016/161 which comes into force in the UK in 2019.
Under this regulation, marketing authorisations holders (MAH) are required to ensure that specified prescription only medicinal product [see Annex I and II of the regulation for product exclusions/inclusions] meet new safety feature requirements; the deadline to implement these requirements is 9th February 2019. The new safety features require these products to have a unique identifier (2D data matrix code and human readable information) and anti-tamper evident features on the packing so that product validity and integrity can be monitored through supply chain up to supply to the patient.
Optident Ltd predominantly supplies persons authorised to supply medicinal product to the public and as such, in line with the Delegated Regulation Article 23, we will perform the necessary checks and decommission the product at despatch point to you. If however you are operating within a healthcare institution or within a pharmacy and wish to perform your own decommissioning on receipt of product, please inform us and we will remove this decommissioning step.
What is FMD:
The EU Falsified Medicines Directive is a European directive that sets about implementing requirements to prevent falsified/counterfeit medicines being made available on the European market.
Who regulates FMD:
Regulators in each European Member State – therefore the Medicines and Healthcare product Regulatory Agency (MHRA) regulate application in the UK. The MHRA is an executive agency of the Department of Health.
Which FMD Regulations are applicable and what are the key compliance timelines:
The EU Falsified Medicines Directive (2011/62/EU) (FMD) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in the European Union (EU) are safe and that trade in medicines is properly controlled. Member States have until 9 February 2019 to implement the final part of the Directive, the ‘safety features’ Delegated Regulation EU 2016/161. The delegated regulation was implemented into law pre UK Brexit therefore this regulation has been adopted into UK law and needs to be applied.
What are the compliance obligations:
Manufacturers are required to place ‘safety features’ on the packaging of certain medicinal products [majority of Prescription only Medicines and Omeprazole].
- a unique identifier (a 2D data matrix code and human readable information)
- an anti-tampering device
Wholesalers/Distributors in the supply chain are responsible to verify the pack authenticity and integrity and decommission the serial number at the last possible step in the supply chain, either by pharmacies [https://fmdsource.co.uk/resources/the-way-forward-for-fmd-in-community-pharmacy] or by the last wholesaler/distributor.
Optident Ltd will verify the product and decommission the unique identifier of a medical product before supplying to dental practitioners; optometrists and opticians; paramedics and emergency medical practitioners; armed forces, police and other governmental institutions; universities and other higher education establishments using medicinal products for the purposes of research and education; prisons; schools; hospices; nursing homes.
Further information available:
Should you need further information please refer to the recent UK Government guidance below which provides guidance and resources for all types of stakeholders in the supply chain as well as a link to the delegated regulation https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features