Brexit: RPs for Import from the EU

Recommendation

11/12 October 2022

The GDP Compliance Manager - Live Online Training

The scenario of a so called "Hard Brexit" (the United Kingdom - UK - to leave the EU with no deal) is still a possibility. All parties involved started plans for such eventuality, including governments and authorities.

The UK Government has been preparing legislation to allow the continued sale of and access to medicines manufactured in the remaining EU. An updated guidance document further clarifies the possibility to distribute products certified by a EU Qualified Person (QP): "If there is a no-deal Brexit, a wholesale dealer may import EU-QP certified medicines form the European Economic Area (EEA*) if certain checks are made by the 'Responsible Person (import) (RPi)'."

This RP is required to implement a system for confirming EU QP certification has taken place when importing products into the UK from EEA.
MHRA points out that an RPi plays "an important role in ensuring the safe control of medicines" and lays down in detail how to become an RPi and how to apply.

* The EEA compromises the remaining EU Member States and three European Free Trade Association (EFTA) states Iceland, Liechtenstein, and Norway into one internal market area governed by the same basic rules.