Pharmaceutical industry Brexit preparedness and its legal consequences for MAH
- 13 November 2017
- API, batch release, Brexit, CMDh, CMDv, CP, DCP, EC, EMA, finished product, GMP, impact, import, legal consequences, MA, MAH, manufacture, marketing authorisation, marketing authorisation holder, medicinal products, MRP, notice, QPPV, RMS, site, transfer, UK's withdrawal, variation,
On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, stating: “The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.