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Posts Tagged ‘UK’

FASFC-Brexitportal

March 13, 2019

Belgium

As from March 30, 2019, the United Kingdom (UK) will no longer be a member of the European Union (EU). Although to date, no agreement between the EU and the UK has been approved, the companies involved in Brexit should anticipate the consequences as much as possible.

As a result of Brexit, new import and export rules will enter into force within a certain period and under conditions that are currently still to be defined. The Belgian Federal Agency for the Safety of the Food Chain (FASFC) will have to carry out import and export controls, mainly focusing on products that pose a risk in the areas of plant health, animal health and food safety. Companies that want to export to the UK or import from the UK must be aware of this and take this into account. If the EU and UK reach an agreement on Brexit, a transition period will apply until the end of 2020 in which all current European rules for the UK remain applicable.

A Belgian portal site on Brexit (www.belgium.be/brexit) has been made available so that companies can easily access all useful information in the context of Brexit. On this National portal, the FASFC also provides a specific FASFC site for companies and a contact centre to support the companies involved as well as possible.

More information can be found here.

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.

What to do: Post-Brexit

June 22, 2017

EU

To prepare the UK’s withdrawal from the EU, EMA and the European Commission published the first in a series of Q&As for pharmaceutical companies on May 31st 2017. This guidance applies to pharmaceutical companies of both human and veterinary medicines and contains information on the location of establishment of a company in the context of centralized procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites.

A series of further guidance documents on the consequences of Brexit will be published here.