Brexit and EU rules for batch testing of medicinal products
- 27 February 2019
- batch release, batch testing, Brexit, CMDh, CMDv, CP, DCP, EC, EMA, exemption, finished product, import, MA, MAH, marketing authorisation, marketing authorisation holder, medicinal products, MRP, notice, template for request, transfer, UK's withdrawal,
According to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality control testing (‘batch testing’) in the EU/EEA. In these cases, Article 20(b) of Directive 2001/83/EC and 24(b) of Directive 2001/82/EC provide that competent authorities may allow importers of medicinal products coming from