Safety features Delegated Regulation under the Falsified Medicines Directive: Joint statement from the MHRA and GPhC

Roles of the regulators as FMD legislation comes into force 

On 9 February 2019 the legal requirements of the safety features Delegated Regulation under the Falsified Medicines Directive (FMD) come into force. All health and care providers, including registered pharmacies, are expected to meet the requirements under UK law. 

The aim is to prevent falsified medicines from entering the legitimate supply chain, protecting the public from potentially unsafe products. The new requirements set out a system where the identity and authenticity of medicinal products is guaranteed by end-to-end verification, as well as a visible anti-tampering device on the packaging.

The General Pharmaceutical Council (GPhC) and the Medicines and Healthcare products Regulatory Agency (MHRA) are working together to make sure the new requirements are met and medicines are safe for the public to use.  

As the regulator for registered pharmacies in Great Britain, the GPhC will use its existing inspection processes to assess whether pharmacies are meeting its standards. For those registered pharmacies that are found not to have met the standards for registered pharmacies, and where a contributing factor relates to breaches of the new safety feature provisions, the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action to meet the standards and requirements under legislation.

The MHRA is responsible for making decisions on and instigating any enforcement action in relation to the safety features legislation, which may include seeking compliance, enforcement notices or, as a last resort, criminal prosecution for the most serious, persistent breaches.

The GPhC and the MHRA will share information, as appropriate, to ensure that the purpose of the legislation is met and that medicines supplied from registered pharmacies are safe for the public to use.

In the event the UK leaves the EU without a Deal, the Government has recently published information regarding the impact on the new FMD safety features requirements.

You can find out more about the implementation and compliance of the safety features under the FMD legislation on the website.

If you have any further enquiries you can contact the MHRA using the details on their website and through the GPhC contact centre