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Pharmacy and Drugs reiterates the regulatory framework for the authorization of vaccines

Pharmacy and Drugs reiterates the regulatory framework for the authorization of vaccines


In accordance with Executive Decree No. 99 of February 15, 2021, which allows issuing, after evaluation of the file, Emergency Use Authorizations (AUE) for vaccines, the National Directorate of Pharmacy and Drugs has issued four AUE up to the date, which are from the pharmaceutical companies: Pfizer / BioNTech, AstraZeneca, Gamaleya (Sputnik V) and Sinovac (CoronaVac), available at the following link:

http: //www.minsa.gob.pa/informacion-salud/autorizaciones-de-uso-de-emerg ...

The National Director of Pharmacy and Drugs of the MINSA, Elvia Lau, specified that the Minister of Health was very clear in saying that private companies that wish to import vaccines must comply with all the requirements to register them. In this sense, it is necessary to clarify that the available vaccines only have AUE in their countries of origin, which will not allow them to present requirements such as the certificate of free sale, among others.

According to the licensee, Lau, it must be guaranteed that the logistics chain of vaccines complies with good transport, storage and dispensing practices and must be applied by suitable personnel.

The feasibility of accepting the cooperation of the private company is being evaluated, for the application, however, the regulatory framework must be created and we reiterate that, in Panama, currently vaccination against Covid 19 is free.

 The Ministry of Health reiterates to the general population that the vaccine from the pharmaceutical company AstraZeneca, which is currently applied by spontaneous demand, does not fall within the vaccination phases, that is; Any man over 30 and a woman over 50 can access it, which is why he urges them to register at raisa.minsa.gob.pa or call 177 to schedule their appointment.

4/22/2021 9:20:39 PM