EIPG notes risk of shortages of medicines in Europe arising from the Falsified Medicines Directive and Brexit

During the EIPG General Assembly held in Casablanca on 5 and 6th May, two Working Groups reviewed the implications for Qualified Persons of the Falsified Medicines Directive and the impact of Brexit on European industrial pharmacists in their roles to ensure availability and accessibility of quality, safe and efficacious medicinal products for patients.

The first Group considered the responsibilities of Qualified Persons involved in serialisation. The structure of a guidance document was discussed and it was recommended to issue the publication as soon as possible after this General Assembly, due to the impending deadlines and increased serialisation activities.

The second Group recommended that clarity is required for the Qualified Persons of pharmaceutical importers in terms of their roles and responsibilities in view of the technological challenges arising from serialisation which they will have to face. The Group noted that all actors in the pharmaceutical supply chain must adapt their quality systems in considerably short time frames and this relies heavily on key individuals, in particular Qualified Persons and Responsible Persons.

Commenting on the outcomes of the Working Groups, EIPG President Claude Farrugia noted that since the Falsified Medicines Directive deadline coincides with Brexit, this exacerbates the potential risk to the availability of medicines.