As Belgium is approaching the 7th week of confinement, special measures continue to apply in order to lead the healthcare and life sciences business during these extreme circumstances, within the national actions for prevention and control of the virus spread.
Following the recommendations of the Belgian National Security Council, the Belgian Competent Authority FAMHP [1] is encouraging teleworking in order to respect social distances in working spaces and ensure its employees’ safety. Continuity of service is, of course, guaranteed and respected in such a situation.
As such, the FAMHP is inviting all partners to electronically submit their files and contact them via email (contact section).
Temporary Ban on the sale of Covid-19 rapid self-tests
On 17 March 2020, Belgium has also adopted the Royal Decree concerning the prohibition of supply, putting into service and use of rapid self-tests for the measurement or detection of antibodies of SARS-COV-2 VIRUS.
The purpose of this prohibition, which applies until 17 September 2020, is to avoid consequences coming from possible misinterpretations of the results. In fact, the suitability of this test for the detection of COVID-19 is yet to be demonstrated.
According to the FAMHP, rapid tests based on related antibodies detection may provide misleading outcomes, as they become positive only several days after contamination. Indeed, patients reassured from a false negative may neglect quarantine and public health guidelines, favoring the spread of the infection. Moreover, self-diagnosis represents a potential threat due to the lay users’ lack of scientific knowledge.
28/04/2020
Filippo Chierchini
Regulatory Affairs Department
Obelis can still assist you in quickly submitting all the other IVDs that are critical for addressing the COVID-19 outbreak!
[1]Federal Agency for Medicines and Health Products