In accordance with Article 114 of Directive 2001/83/EC, Member States have the right to require the marketing authorisation holder (MAH) of a human immunological medicinal product or a medicinal product derived from human blood or plasma to submit samples from each batch for examination by an Official Medicines Control Laboratory (OMCL) or a laboratory that a Member State has designated for that purpose before the market release.

Such right exists unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications.

In the UK, independent certification under article 114 is carried out by the National Institute for Biological Standards and Control (NIBSC).

On February 19, 2019, the NIBSC issued guidance for manufacturers to clarify what happens in case of a no deal Brexit.

On its website it reads:

“In the event of a no deal scenario, the UK will no longer be subject to EU Directive 2001/83/EC (Article 114(1)). In this outcome, as outlined in section 1.16 in the further guidance published on 4 January 2019, NIBSC will be a stand-alone National Control Laboratory and the UK will require national certification by NIBSC before batches of biological medicines can be placed onto the UK market, unless the batch has an EU Official Control Authority Batch Release (OCABR) certificate issued on or before 29 March 2019, or was manufactured in and certified by a country with whom the UK has a mutual recognition agreement (MRA) in place (initially expected to cover batches manufactured and released in Switzerland or Israel).”

In other words, in the event of a no deal Brexit, the regime for UK certification would be subject to the following changes:

  • After March 29, 2019 (currently, the withdrawal date), the UK will carry out its own batch release of biological medicines at NIBSC taking a risk-based approach to laboratory testing.
  • NIBSC will decide whether to rely on a paper assessment to issue the UK certificate or to carry out laboratory testing of the batch. NIBSC will review all data, including any release certificate issued by a laboratory in an approved list, where available, as well as potential risks to public health.
  • If no such certificate is available, NIBSC will carry out a full laboratory assessment, except where NIBSC indicates differently.
  • The expectation is that NIBSC will independently test and certify batches that are to be marketed exclusively in the UK.
  • There will be new statutory fees to enable NIBSC as the UK National Control Laboratory to charge for certification and testing in the UK, broadly the same as the current fees charged by NIBSC in its role as an OCABR laboratory.

Such guidance follows earlier guidance issued by the European Medicines Agency on the same topic as part of its Brexit Q&A. The guidance documents follow the same line of thinking but differ on one point:

Whilst the UK after a no deal Brexit will still accept certificates from EU control labs issued before the Brexit date, the EU in its guidance states that import of products after Brexit based on an UK certificates issued before Brexit will not be possible as the mutual recognition of Official Control Authority Batch Release will cease.

DG SANTE confirmed in a letter dated February 21, 2019, that although batch release sites must be within the EU-27, some quality-control testing of medicines bound for the EU can continue to occur in the U.K. beyond the withdrawal date. This exemption could apply in cases where there are objective reasons beyond the control of the MAH that may prevent it from making a timely transfer of such testing activities to the EU by the withdrawal date.

The letter lays out conditions for an “exemption” to allow testing in the UK. In order to make use of this exemption, affected MAHs must immediately notify the relevant national competent authority that granted the MA (or EMA in the case of centrally authorised products). The notification must be submitted without undue delay but in no case later than the withdrawal date. In the notification the MAH must:

  • specify the batch release site in the EU27;
  • confirm that the qualified person established in the EU27 is responsible for the quality
    control testing site in the UK;
  • confirm and set out their precise timetable for transfer of the quality control testing
    site (which should allow the process to be completed quickly and in principle by the
    end of 2019 at the latest);
  • specify the period of time and batches (packs and quantities) that are requested to be
    exempted. This should be strictly restricted to what is necessary;
  • commit to providing batch testing results for those batches from the existing facilities
    within the UK; and
  • transfer samples of those tested batches together with the testing results to the batch
    release site in the EU27 in due time to make them available for inspection.
Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

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