EFPIA, Medicines for Europe and AESGP call for a Mutual Recognition Agreement on Good Manufacturing Practice in the context of EU-UK Future Relationship

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EFPIA, Medicines for Europe and AESGP call for a Mutual Recognition Agreement on Good Manufacturing Practice in the context of EU-UK Future Relationship

10.02.20

The pharmaceutical industry in Europe has worked to support the EU27 and UK to reach an agreement that will allow patients to receive medicines and medical technologies without disruption and provide long term co-operation between the EU and the UK in areas such as research, clinical trials, pharmacovigilance and access to talent. Our industry’s stance remains that the EU and UK should have the closest possible relationship for pharmaceuticals, prioritising the health of citizens and the uninterrupted supply of medicines.

In the coming months, the EU and UK should conclude an agreement that secures the greatest regulatory alignment and cooperation on human medicinal products. Reflecting precedents from previous agreements, an FTA should also include ambitious provisions on sharing of data, the protection of intellectual property (IP), customs facilitation, as well as rules of origin (RoO). We also believe the EU and UK should establish a working group on pharmaceuticals and medical devices as per the EU-South Korea Free Trade Agreement.

Given the current complete alignment of regulatory standards, the EU-UK negotiations represent a unique opportunity to continue this high level of compatibility and to secure streamlined processes and procedures between the EU and the UK in the interest of patients.

Read here the full call for a EU-UK Mutual Recognition Agreement on Good Manufacturing Practice.