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Posts Tagged ‘europe’

EU-US Mutual Recognition Agreement for inspections

May 8, 2019

EU

With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA’s approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That makes 24 approved EU states so far. There are 4 countries left: Germany, the Netherlands, Luxembourg and Slovakia. By 15 July, 2019 though, all authorities and countries are supposed to have been reviewed and approved. Regular updates may be found in a question and answer document on the EMA’s website.

EU rules for batch testing of medicinal products after BREXIT

February 28, 2019

European Union

In light of the withdrawal of the United Kingdom from the European Union, the European Commission has published a letter on the rules for batch testing of medicinal products after the Brexit.

The competent authorities may allow marketing authorisation holders (MAHs), for a limited period of time and only in justified cases, to rely on quality control testing performed in the United Kingdom, under the following conditions:

  1. By the withdrawal date, a batch release site in the EU27 must be identified by the marketing authorisation holder.
  2. By the withdrawal date, the batch release site must be supervised by a qualified person established in the EU27.
  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 must be 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 must immediately notify the relevant national competent authority that granted the marketing authorisation (or EMA in case of centrally authorised products). This notification must detail the period of time and batches to be exempted and provide several commitments. It must be submitted without delay and in no case later than the 29th of March 2019.

After assessing whether a request is justified, the national competent authority or EMA can only grant the “exemption” for the time period strictly necessary and for the specific batches identified.  As MAHs are obliged to notify any issue that may cause disruption of supply to the competent authorities two months in advance, this means that if companies expect to encounter problems as of the withdrawal date, this notification needs to be done now.

Of note, in case the Withdrawal Agreement, which provides for a transition period, is ratified by EU Institutions and the UK, the MAHs will be able to continue to rely on quality control testing conducted in the UK until the end of the transition period. In that case, there will be no need for an exemption.

More information can be found here.