The Ministry of Public Health, through the Directorate for Medicines, Food and Health Products (Digemaps), has issued a special permit for the import and emergency use of Pfizer-BioNTech against COVID-19.
The temporary exemption document and the special transitional permit for import and emergency use in humans, establish the import authorization for the vaccine developed by Pfizer-BioNTech against COVID-19.
And it was granted by Digemaps, a body authorized as a body responsible for the regulation, control, surveillance and surveillance of medicines.
In accordance with the terms set out in the authorization, Issued on 8 February this year, Pfizer must provide health surveillance reports every 6 months and, above all, changes in the efficacy profile and periodic health surveillance reports.
In addition, he is temporarily exempted from complying with certain requirements and requirements of Decree no. 246-06 which establishes the regulations for manufacturing, preparation, quality control, supply, circulation, distribution, marketing, information, advertising, import.
In addition, the storage, distribution, evaluation, registration and donation of medicinal products so as to grant special temporary permission for the import and emergency human use of the aforementioned vaccine.
Prior to signing the document, Digemaps indicates that it has received and evaluated all documentation and verified the safety and efficacy of the vaccine and that it complies with the characteristics necessary for its importation and emergency human use, in accordance with current legislation. health.
The temporary permit is based on the provisions of Resolution no. 000053 of 30 December 2020, of the Ministry of Public Health and Social Welfare, authorizing Digemaps, in accordance with the provisions of Article 113 of Law 42-01, to provisionally grant health records for vaccines against COVID-19, as well as legal exemptions from obtaining health registration.