Coronavirus: refinement of the measures taken by the FAMHP to avoid drug shortages

As Belgium acts as a logistics platform for certain medicinal products, the ban on exports outside the EEA (European Economic Area) could result in other countries being needlessly prevented access to medicines. The export ban will be replaced by a notification requirement to the FAMHP. The FAMHP can still ban exports in the interest of Belgian patients.

On 01 April 2020, the FAMHP took a certain number of measures to avoid drug shortages during the coronavirus pandemic (COVID-19). These measures were refined in the consolidated version of the Administrator General of the FAMHP’s decision relating to various urgent measures concerning specific drugs to combat the drug shortage during the SARS-CoV-2 pandemic.

Replacing the ban on exports outside the EEA with a notification requirement with the possibility of opposition

In order to prevent other countries from suffering unnecessary drug shortages, the ban on exports outside the EEA has been replaced by a notification requirement. The FAMHP can still file an opposition, within three working days, if this is in the interest of Belgian patients, in which case the medicinal products cannot be exported.

Instructions regarding the notification requirement:

  • Within the EEA: by email to coronashortages@afmps.be. The subject line of the email should be: EEA export notification - [MA Holder name] - [Medicinal product name]". The target Member State and the quantities to be exported must be specified. Follow the template (NL, FR or EN) and use the following file name: EEA export notification_[MA holder name]_[Medicinal product name]_yyyy/mm/dd.
  • Outside the EEA: by email to coronashortages@afmps.be. The subject line of the email should be: Export notification outside the EEA - [MA Holder name] - [Medicinal product name]. The target country and the quantities to be exported must be specified. Follow the template (NL, FR or EN) and use the following file name: Export notification outside the EEA_[MA Holder name]_[Medicinal product name]_yyyy/mm/dd.

Revision of the list of medicinal products

The list of medicinal products and raw materials concerned has also been revised. For example, for the sake of clarity, IVs (form of medication suitable for intravenous administration and important in the treatment of patients with COVID-19) have been added if necessary. The situation is constantly evolving, and the list has also been adapted accordingly.

More information

Decree of modification

 

Last updated on
23/04/2020