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Posts Tagged ‘brexit’

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.

EMA moves to Amsterdam

January 24, 2018

EMA

Finally, it is decided! The European medicines Agency (EMA) will relocate to Amsterdam following UK’s withdrawal from the European Union. The decision followed an assessment of the bids by the European Commission and EMA. By 30 March 2019 at the latest, EMA should be in operation in Amsterdam.

EMA’s relocation will also impact the continuous supply of medicines for human and veterinary use within the European Union. Marketing authorisation holders, applicants and sponsors of centrally authorised medicines should consider which changes have to be addressed before the United Kingdom leaves the European Union. Necessary changes should be made by 30 March 2019 at the latest. To help pharmaceutical companies prepare for Brexit, EMA has published a procedural guidance and a Questions & Answers document.

EMA’s relocation is delayed

September 11, 2017

EU

The relocation of the European Medicines Agency (EMA) due to Brexit will take longer than expected. Nineteen countries offered to host EMA and especially the Netherlands are very interested to become EMA’s new home base. One of the reasons for this is the creation of many jobs resulting in several economic benefits.

The host country has to fulfill 6 criteria to be an appropriate candidate. The most important criterium is the ability for EMA to be functional immediately following Brexit. Also important are accessibility, international schools, jobs and care for partners and children, operational continuity and geographical distribution. By the end of September, EMA will publicly share its evaluation. The voting will take place in November and the final decision will be announced 20 November 2017.

Also Belgium applied, so that the best may win!

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.

Relocation of European Medicines Agency

April 14, 2017

The European Medicines Agency (EMA) is currently located in Canary Warf in London. Following the triggering of Article 50, the process will commence to decide on its relocation. The Agency works with individual regulatory authorities from all 31 European Economic Area member nations. Assuming it moves out of London when Brexit is complete, it would mean shifting 890 jobs currently located in Canary Wharf in East London. The decision on the seat of the agency will not be taken by EMA, but will be decided by common agreement among the representatives of the member states. This might be a hard nut to crack!

Sweden believes it is the “most serious contender” among a half-dozen nations to be the new home of the EMA. But although the Swedes are confident of luring the EMA, they face stiff competition in a bidding war also involving the Irish Republic, Spain, Denmark, Germany and Italy. In our region, both Belgium and the Netherlands have applied as official candidate. And who knows, in case of dispute, Brussels might be the classic EU compromise.