As an extra option for users in Belgium, the Belgian Federal Agency of Medicines and Health Products (AFMPS) has decided to allow antigens self-tests to be sold out of pharmacies. Through the amending decree of June 24, 2021, COVID-19 antigen self-tests can be sold freely as of the July 1, 2021.
Moreover, as of the aforementioned date the exception on which professional-use antigens tests could be sold in pharmacies to non-professionals comes to an end, a measure established due to the lack of such tests availability in the past. Nevertheless, please note that tests marketed before July 1, 2021, under this exception can still be sold.
It is also important to note that the amending decree recalls that certain conditions should be met for these self-tests to be sold; as a matter of fact, they must follow the applicable IVD Directive, e.g. to be CE marked, notified to the AFMPS, the distributor must be registered to the AFMPS and the device’s IFUs and labels must be provided in the three official Belgian languages (French, Dutch and German). Thus, in order to gain a more extensive view of the requirements for self-tests in Belgium, please kindly consult our article on the conditions and approval process for COVID self-tests (Mihelcic, 2021).
Pablo De Mingo
Regulatory Affairs Department
Contact Obelis to receive excellent assistance on this and many other matters on your products’ route towards EU compliance!
AFMPS (2021). Coronavirus : les autotests antigéniques peuvent désormais aussi être vendus ailleurs qu’en pharmacie. Retrieved on 16/07/2021 from https://www.afmps.be/fr/news/coronavirus_les_autotests_antigeniques_peuvent_desormais_aussi_etre_vendus_ailleurs_quen
Mihelcic, A. (19 April 2021). COVID self-tests in Belgium: Conditions and approval process. Retrieved on 16/07/2021 from https://www.obelis.net/news/covid-self-tests-in-belgium-conditions-and-approval-process/