The draft Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use will replace Ministerial Decision No. 00385-2019 issuing the Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological medicines for human use and consumption, which was published in the Special Edition of Official Journal No. 1011 of 12 July 2019, and the amendment thereto under Ministerial Decision No. 00226-2023, which was published in Official Journal No. 451 of 5 December 2023. The purpose is to establish the legal and technical requirements that will ensure quality, safety and efficacy and under which sanitary certificates will be issued for biological products for human use, as well as the criteria for the control and surveillance of such products.

Proyecto "Normativa Técnica Sanitaria Sustitutiva para la obtención del registro sanitario, control y vigilancia de productos biológicos de uso humano" (Draft Substitute Sanitary Technical Regulation for the issuance of sanitary certificates for, and the control and surveillance of, biological products for human use) (100 pages, in Spanish)

The purpose of the notified draft Substitute Sanitary Technical Regulation is to establish the legal and technical requirements that will ensure quality, safety and efficacy and under which sanitary certificates will be issued for biological products for human use, as well as the criteria for the control and surveillance of such products. The following products are not covered by the notified draft Regulation:

a. Allergen products prepared on the basis of an individual prescription by a qualified and authorized medical professional;

b. Advanced therapy products not industrially manufactured, prepared on occasion by a hospital facility under the exclusive professional responsibility of a trained physician to fulfil an optional individual prescription for a made-to-measure product for a single patient; and

c. Research products, which are governed by Ministerial Decision No. 0075-2017 issuing the Regulation for the approval, development, surveillance and control of clinical trials, or any document that might replace it.

The draft Substitute Sanitary Technical Regulation is binding on all natural or legal persons, whether domestic or foreign, governed by public or private law, that request sanitary certification, re-certification or an amendment thereto for biological products for human use in the country.