As in our previous article, on 1 September 2020, the Medicines and Healthcare products Regulatory Agency released a tranche of new Brexit guidance, which covers a broad range of matters. We are still digesting the guidance.
Notably absent, however, is any guidance on the application of the Falsified Medicines Directive (FMD) in Northern Ireland. A number of issues with regards to the FMD in Northern Ireland have been identified, and we were hoping to receive more guidance on this topic by the end of August. This has not eventuated.
We will send a more detailed note out next week about the current state of play with FMD in Northern Ireland.