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Posts Tagged ‘Belgium’

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.

Countdown to the launch of the new EudraVigilance system on 22 November 2017: Impact for Belgium and the Netherlands

November 8, 2017

The new EudraVigilance system will become operational on 22 November 2017. In order to implement this new system, the current EudraVigilance system is unavailable as of today (8 November 2017), 1.00 a.m. (Brussels time) until 22 November 2017, 10.00 a.m. (Brussels time), when the new system goes alive. So, we just entered the downtime period. During this downtime period, alternative measures apply for reporting adverse drug reactions (ADRs).

Impact for Belgium and the Netherlands

  • During the downtime period, it is not possible for marketing authorisation holders and sponsors to submit ICSR’s to EudraVigilance.
  • The Belgian agency (FAMHP) will stop sending (serious) ICSRs to the marketing authorisation holders as of 8 November 2017.
  • ICSRs that require submission during the downtime period (these are ICSRs of which the term of 15 days after receipt expires within the downtime period) should be submitted to the new EudraVigilance system within 2 working days from the moment the EudraVigilance system is again operational.
  • Concerning ICSR reporting, there will be no change in languages: Dutch, French and English are acceptable to report ICSRs.
  • Articles from Literature do not need to be resent locally.
  • During the downtime period in Belgium, Emerging Safety issues should be sent to adr@fagg.be. These are reports that may affect the product’s benefit-risk balance. In the Netherlands, there reports have to be sent to the Medicines Evaluation Board (MEB).

More information can be found on the following links: