Koteze, Sokola 1 st., 83-200 Starogard Gdanski, Poland
Phone/Fax: (+48) 58 531 02 59
Phone: (+48) 606 93 82 51

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,

ASE Pharma Solutions

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.

Brexit capsule

The requirement of a batch release site established in the Union is a fundamental pillar of the Union system of ensuring quality of medicinal products being placed on the Union market. With regard to the batch release sites currently located in the United Kingdom marketing authorisation holders therefore need to comply with this requirement at the latest by the withdrawal date.

However, with regard to the quality control testing there may be objective reasons beyond control of the marketing authorisation holders that may prevent timely transfer of such testing activities to the Union by the withdrawal date.

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 third countries to have in justifiable cases certain of the controls carried out by third parties.

Chemical lab

In applying these provisions, competent authorities may allow marketing authorisation holders, for a limited period of time, for the specific batches, and under some conditions, as a justified case, to rely on quality control testing performed in the United Kingdom – “the exemption”.

In order to make use of this “exemption”, affected marketing authorisation holders must immediately notify the relevant national competent authority that granted the marketing authorisation (or EMA in case of centrally authorised products). The notification must be submitted without undue delay but in no case later than on 29 March 2019.

All details you will find here.


Sources: EC, EMA, CMDh, CMDv

Related entries:

Pharmaceutical industry Brexit preparedness and its legal consequences for MAH

Updated: 2019-03-06