The Belgian federal agency for medicines and health products (AFMPS or FAGG) provides that Belgium acts as a logistical platform for certain medicinal products. The ban on export of medicinal products outside the European Economic Area (EEA) could result in other countries not having access to medicinal products unnecessarily. The AFMPS has decided to replace the ban on exports outside the EEA by an obligation to notify exports to the AFMPS. The AFMPS can prohibit these exports if it is the interest of Belgian patients.
On 1 April 2020, the AFMPS took a number of measures to avoid a shortage of medicinal products in the context of the coronavirus pandemic (COVID-19). These measures included a ban on export of certain medicinal products outside the EEA and an obligation to notify the AFMPS of exports within the EEA. On 8 April 2020, these measures were reviewed in the consolidated version of the Decision of the AFMPS's General Administrator on various urgent measures concerning specific medicines to combat the shortage of medicines in the context of the SARS-CoV-2 pandemic.
The AFMPS replaced the ban on export of medicinal products outside the EEA with a notification obligation.
In order to prevent other countries from suffering unnecessarily from a shortage of medicinal products, the ban on export of medicinal products outside the EEA has been replaced by a notification obligation. The AFMPS can still oppose export within three working days of receipt of a notification if this is in the interest of Belgian patients. In this case the medicinal products cannot be exported.
The AFMPS's new measures reflect the European Commission's Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak also published on 8 April 2020. The European Commission Guidelines provide that a total ban on export of medicinal products is not in line with the Treaty of the Functioning of the European Union and impede the functioning of the single market. In the Guidelines, the European Commission calls on all EU Member States to lift unjustified export bans for medicinal products within the internal market.
Procedures concerning notification to the AFMPS of exports:
- Exports within the EEA: by e-mail to coronashortages@afmps.be. The title of the e-mail is: Notification d'exportation dans l'EEE - [MA holder] - [Medicinal product name]. The Member State of destination and the quantities to be exported must be indicated. The following template should be used (also available in FR or NL) and the template should have the following file name: Notification Export dans EEE_[MA holder]_[Medicinal product name]_aaa/mm/jj.
- Exports outside the EEA: by e-mail to coronashortages@afmps.be. The title of the e-mail is Notification Export hors de l’EEE - [MA Holder name] - [Medicinal product name]. The country of destination and the quantities to be exported must be indicated. The following template should be used (also available in FR and NL) and the template should have the following file name: Notification Export hors EEE__[Name of the MA holder]_[Name of the medicinal product]_yyyy/mm/dd.
The list of medical products and raw materials have been revised
The AFMPS has revised the list of medicinal products and raw materials that are considered essential and critical. The AFMPS states that the situation is constantly evolving and the list will be adapted accordingly.
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