The MHRA and General Pharmaceutical Council (GPhC) have today (17th January 2019) published a joint statement on their respective roles in relation to the enforcement of the FMD legislation in England, Scotland and Wales.
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.