QCOSTARICA – The Ministry of Health has issued requirements for the import and use of vaccines against covid-19 in the private sector, following the interest of private clinics and pharmacies in starting the processes to sell vaccines against covid-19 in Costa Rica.
Through resolution MS-DM-RM-0933-2021, the Ministry of Health intends to “make it totally clear to the business sector” the steps required to obtain authorization for the use and import of the vaccines, once the pharmaceutical companies make them available to the private sector.
Currently, companies like Pfizer, AstraZeneca, Moderna and others have filling contracts with governments around the world.
For that, the National Vaccination Commission sees difficult sale of the vaccine against covid-19 in private clinics and pharmacies in the short term
The document details that “allowing the sale of the vaccine against covid-19 for the private market guarantees access to health to a greater number of people and to achieve herd immunity in a more accelerated way.”
In addition, it emphasizes that the authorization will be in force as long as the state of national emergency is maintained.
Health explained that the procedure would be carried out before the Dirección de Regulación de Productos de Interés Sanitario (Directorate for the Regulation of Products of Health Interest), where the application and other required information are managed, such as certificates of good practices and details of the labeling.
Documentation for the respective verification of the product’s quality, safety and efficacy parameters must also be delivered; have strict regulatory agency approval and/or prequalification from the World Health Organization (WHO) and vaccine efficacy of at least 60%.
Similarly, once the doses are available in the country for sale and/or application, the respective report of the vaccination process and the post-vaccination follow-up of events supposedly attributable to vaccination and immunization must be coordinated.
In addition, licensed sites must ensure that the vaccine is distributed with approved labeling and that proper storage and cold chain is maintained until it is delivered to the vaccination sites.
Health indicated that the legal representative must submit Safety Reports on a monthly basis, within 15 days after the last day of a month, beginning after the first full calendar month after authorization.
It also mandated that licensed entities must maintain records regarding the release of the vaccine for distribution (ie, lot numbers, quantity, date of release).
In addition, the Directorate for the Regulation of Products of Health Interest may request from the legal representative and authorized sites any information it deems pertinent in relation to the authorized vaccine.
These are other requirements that vaccination providers must meet:
- Guarantee that vaccination is carried out in establishments authorized to provide the vaccination service, or that have the temporary vaccination service authorized by the health governing area of the Ministry of Health.
- Ensure compliance in relation to contraindications, precautions and warnings, adverse reactions, interactions, route of administration and authorized dosage for the vaccine
- Provide information to people about the possible adverse effects associated with the vaccine they receive, provide a vaccination card and the information necessary to receive their second dose.
- Guarantee registration on the SINOVAC platform.
Finally, Health indicated that the marketing authorization is a prerequisite for the importation of vaccines, because their import must be managed through the Sistema de Ventanilla Única de Comercio Exterior (Sivuce) de la Promotora del Comercio Exterior de Costa Rica (Procomer).
“Once the full authorization request is submitted, the Administration has a period of 10 days to resolve,” ends the document signed by the Minister of Health, Daniel Salas.