By Supreme Decree No. 014-2022-SA, the regulatory provisions for the importation or procurement of vaccines and medicines ("Product") against the SARS-CoV-2 coronavirus ("Covid") ("Regulation") have been approved.

The most relevant aspects of the Regulation are the following:

  • The importation or procurement authorization is granted by DIGEMID and it empowers its holder to import or acquire the Products. The commercialization of these Products is not allowed under any modality. Likewise, the authorization is non-transferable.
  • Private companies, regional governments or local governments may be holders of the authorization.
  • The authorizations differ depending on the type of activity and the holder.
 Private companiesRegional and local governments
Import authorization

Allows the importation of Covid vaccines.

Vaccines must have a conditional health registration in Peru.

Allows the importation of vaccines and medicines against Covid.

Vaccines and medicines must have a conditional health registration in Peru.

Procurement authorizationAllows the procurement of Covid vaccines purchased directly from the holder of the conditional health registry in Peru.Allows the procurement of vaccines and medicines against Covid purchased directly from the holder of the conditional health registry in Peru.

 

  • The Products included in the Regulation are those that have a conditional health registration.
  • The holder of the authorization guarantees both the vaccine and the immunization for their staff at no cost.
  • It establishes what the supply chain of the Products will be.
  • The holder of the conditional health registration must authorize the importation or procurement of the Products.
  • Authorizations must be granted within seven calendar days.
  • Unused vaccines and medicines will be donated to the Ministry of Health.
  • Private companies will be responsible for compensation to vaccinated people, in case of adverse effects attributed to vaccination or immunization.

The provisions can be reviewed in detail here.

We trust that this information will be useful to you and your company. If you require legal advice on this issue, do not hesitate to contact us.