Regulation that regulates the presentation and content of the documents required in the Registration and Re-registration of Biological Products: Vaccines

The Ministry of Health through the Annex to Supreme Decree No. 020-2021-SA, published on July 31, 2021 in the Official Gazette "El Peruano", published the “Regulation that regulates the presentation and content of the documents required in the registration and re-registration of biological products: vaccines”. This document consists of two (2) titles, eight (8) articles, three (3) temporary supplementary provisions and three (3) annexes, and becomes effective after six (6) months, counted from the day after its publication.

Being that the purpose of this document is to establish the rules that regulate the presentation of the documents required in the registration and re-registration of biological products: vaccines; as well as to establish the information that must be contained in the documents required for registration and re-registration.

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