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.
Read the full joint statement
In July 2018, the Government launched a public consultation on the steps proposed to make sure the UK meets its obligations to transpose the provisions of the Falsified Medicines Directive (FMD) requiring ‘safety features’ to appear on the packaging of certain medicinal products.
The consultation closed in September, and the MHRA has published the following document which provides their official response to the more than 50 replies received from a wide range of stakeholders.
Final consultation response: FMD features
As with all EU regulations, the Delegated Regulation on ‘safety features’ will apply automatically in all EU Member States and therefore, as of 9 February 2019, these new requirements will be directly applicable as part of UK law.
The consultation focused on the national flexibilities in the Delegated Regulation, and the level of sanctions applied to a breach of each new requirement, for which the Government is obliged to take additional legal steps, culminating in the laying of a Statutory Instrument in Parliament.
Overall, the responses broadly supported the Government’s proposed positions regarding the level of sanctions imposed and on each national flexibility, where the UK has legal scope to make changes. Therefore, the Government intends to implement as per the positions proposed in their consultation, with the exception of Article 26(3), which exempts those within a healthcare institution from decommissioning under certain conditions. The Government did not originally see any benefit of applying this flexibility, but now understands it could be beneficial for certain healthcare institutions, in line with the criteria fixed in the Delegated Regulation.
Their additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption is available here:
Additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption