Vaccination by private entities Resolution 507 of 2021
Resolution 507 of 2021 issued by the Ministry of Health established the requirements and conditions to import, acquire, and administer vaccines against Covid-19 by private entities.
The Resolution provides that only the legal entities authorized as importers within the Emergency Use Health authorization (ASUE for its initials in Spanish) can import into Colombia the vaccines against Covid-19. In this sense, there are two ways to acquire vaccines: i) direct importation or ii) negotiation with authorized importers. To be an importer, authorization from the owner of the ASUE will be required and thus be included in said authorization.
Any potential new importer shall comply with the conditions that gave rise to the authorization of the ASUE, including but not limited to the storage conditions of the vaccine, traceability and pharmacovigilance obligations, labeling, among others.
The special liability regime established in Article 5 of law 2064 of 2020, will not be applicable for vaccines supplied by private individuals, therefore the general rules of tort liability will apply.
On the other hand, concerning the administration of vaccines, these must be administered in establishments authorized to provide vaccination services by the local or regional competent entities. Private entities can use the health network already established by the National Vaccination Plan Against Covid-19. However, they must not use the same vaccination sites or equipment used by the national government for the general population.
Private entities may administer vaccines to its employees. It is possible to establish a prioritization agenda to administer the vaccines between employees, but the companies cannot exclude any employee. We were informed that Government will clarify the Resolution stating that once all the employees are vaccinated, they can also vaccinate the families of the employees.
The immunization process shall be carried out free of charge.
The companies may carry out the negotiation and importation of Covid-19 vaccines as of April 21, 2021, but its administration will only be allowed once the National Vaccination Plan starts stage 3. In other words, after the individuals of 60 years or more and health workers are vaccinated. The exact date will be published by the Ministry of Health.
Author: Daniel Cardona I [email protected] I Life Sciences
Author: Juan Carlos Orjuela I [email protected] I Life Sciences
