The Ministry of Public Health, under the auspices of the Directorate for Medicines, Food and Sanitary Products (Digemaps), has issued a special permit for the import and use of human emergencies by Pfizer-BioNTech against COVID-19.
The Temporary Extension Document and Special Transition Permit for Import and Use in Emergencies for Humans, establish the authorization for the import of the unlocked vehicle by Pfizer-BioNTech against COVID-19.
It is operated by Digemaps, an agency authorized as a competent body in matters of regulation, control, taxation and the vigilance of medicines.
According to the terms established in the permit, issued the February 8th of this year, Pfizer has to sum up, every 6 months, security information corresponding to sanitary vigilance and above all, changes in the efficiency profile and periodic security correspondence to sanitary vigilance.
In addition, the completion of the requirements and requirements of Decree no. 246-06 which establishes the regulatory framework, for manufacturing, elaboration, quality control, suministro, circulation, distribution, commercialization, information, information
In addition, assessment, dispensation, evaluation, registration and donation of medicines, in order to be the special transit permit for importation and use of human emergence from the evacuation.
Preview of the document firm, Digemaps indicates that receipt and evaluation all document the documentation and verification of the safety and efficacy of the vaccine and the mishap with the characteristics required to be imported and for its use in human emergence, compliance with the legislation sanitary vigente.
The temporary permit is based on the establishment in Resolution No. 000053 of 30 December 2020, of the Ministry of Public Health and Social Assistance, as authorized by Digemaps, in compliance with the provisions of Article 113 of the Law 42-01, to provide provisional form, sanitary records for vacancies against COVID-19, as well as Legal dispensations of the sanitation register maintenance.