The market for the sale of COVID-19 vaccines in Mexico is very close
The market for the sale of COVID-19 vaccines in Mexico is very close, and it will only be a matter of obtaining the necessary permits.
On Friday, September 22nd, the Federal Commission for the Protection against Sanitary Risks (Cofepris) published the call for pharmaceutical companies to undergo the sanitary registration process that will allow them to commercialize these vaccines in the country.
This registration will enable the sale of COVID-19 vaccines in Mexico through pharmacies nationwide.
In a statement, the federal health authority called on companies that own COVID-19 vaccines to enroll in the process.
This marks the transition from Emergency Use Authorization to the Sanitary Registration of their vaccines, allowing them to start selling them in the domestic market.
“The evaluation process will be an unprecedented regulatory exercise under the principle of ‘glass box,’ setting an example for its proactive transparency and technical efficiency.”
Requirements for pharmaceutical companies to obtain the registration for the sale of COVID-19 vaccines in Mexico:
Cofepris reminded pharmaceutical companies that, before obtaining the sanitary registration (a mandatory requirement for commercializing any vaccine or health product), they “must prove the quality, safety, and efficacy of the products,” which will be assessed by specialized personnel in biological and biotechnological medicines.
Furthermore, it warned that during this process, companies “must refrain from any attempt to interfere, directly or indirectly, in the evaluation of the pharmaceutical product.”
“Any irregular activity will be reported to the Ministry of Public Function (SFP) and the competent authorities in the field.”
¿Who can apply for the sanitary registration sale of COVID-19 vaccines in Mexico ?
According to the call, the companies eligible to apply for the sanitary registration for the sale of COVID-19 vaccines in Mexico are those entities or companies that have received Emergency Use Authorization for the SARS-CoV-2 vaccine.
In this regard, the institution pointed out that authorizations issued by Cofepris that are currently valid “will retain their validity as long as these drugs and supplies are necessary to continue the National Vaccination Policy against the SARS-CoV-2 virus for the Prevention of COVID-19 in Mexico, or for the long-term management plan determined by the Ministry of Health.”
This is in accordance with the Decree declaring the end of the COVID-19 health emergency.
The health authority also urged the public “not to indiscriminately use any COVID-19 vaccine” as the risk-benefit of each application should be considered.
It added that vaccines to prevent the virus, included in the National Vaccination Policy against SARS-CoV-2, are universal and free.
In this regard, it stated that the administration of vaccines outside of this national vaccination policy should be done “under strict medical recommendation.”
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