News about GMP/cGMP


Brexit and EU: Exemption for Batch Testing

With not even one month left until Brexit, the European Commission has sent a letter to the Director of the EMA (European Medicines Agency) and the EU27 Heads of Medicines Agencies to inform about an exemption to certain batch testing requirements for pharmaceutical manufacturers that perform their batch testing in the UK.

In  particular,  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. Therefore, the process of batch testing has to be moved to the EU in order to import products and cannot be conducted in the UK any more. Subject to the condition that the UK leaves the EU on March 29, 2019, MAHs need to comply with this requirement to that date.

According to the EC, it is acknowledged that some companies may not be able to set up those processes in the EU by then. It is said that

“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.”

It is further clarified that due to this, competent  authorities  in the EU may  allow  marketing  authorisation holders,  for  a  limited  period  of  time,  as  a  justified  case,  to  rely  on  quality  control  testing performed  in  the  United  Kingdom  (“the   exemption”),  under  the  following conditions:

  1. A batch release site in the EU27 is identified by the marketing authorisation holder by the withdrawal date.
  2. The batch release site is supervised by a qualified person established in the EU27 by the withdrawal date.
  3. The establishment designated by the third party conducting the quality control testing may be verified by a competent authority of the EU27, including on the spot checks.
  4. All  necessary  steps  have  been  taken  to  prepare  the  transfer  of  the  quality  control testing site from the United Kingdom to the EU27

To make use of this exemption, affected MAHs have to notify the authority that granted the marketing authorisation or the EMA no later than on 29 March 2019. In  the  absence  of  such  an  exemption,  if  the  testing  of  the  batch  does  not  take  place  in  the EU27, as of the withdrawal date, the marketing authorisation will become non-compliant.