Life Sciences Newsletter - August 2026

PROCEDURES BEFORE DIGESA AND FEE REFUNDS

Through Notice No. 05-2026-DIGESA/MINSA, published on August 3, 2026, DIGESA reported that the new Single Text of Administrative Procedures (TUPA) of the Ministry of Health, approved by Supreme Decree No. 011-2026-SA, includes only two administrative procedures under its authority: (i) sanitary authorization for wastewater treatment and final disposal systems; and (ii) sanitary authorization for the operation of cemeteries and/or crematoria.

DIGESA also reported that the other procedures administered by DIGESA continue to be processed normally under the right of administrative petition and at no cost to the applicant. It further clarified that, where the Foreign Trade Single Window (VUCE) generates charges for procedures that should be free of charge, DIGESA will ensure the refund of the amounts paid.

Along the same lines, through Notice No. 06-2026-DIGESA/MINSA, published on August 12, 2026, DIGESA established the procedure and requirements for requesting refunds of payments made improperly, by mistake, or in excess, specifying the applicable conditions and the form that applicants must submit. Refund requests may be filed in respect of payments made from July 22, 2026.

DOCUMENTS DEEMED EQUIVALENT TO THE GMP CERTIFICATE

Through Directoral Resolution No. 121-2026-DIGEMID-DG-MINSA, published on August 5, 2026, the “List of Documents Deemed Equivalent to the Good Manufacturing Practices (GMP) Certificate,” approved by Directoral Resolution No. 063-2026-DIGEMID-DG-MINSA, was amended.

The amendment is intended to reinstate the Pharmaceutical Product Certificate (CPP) issued by the European Medicines Agency (EMA) for products originating from European Union countries as a document deemed equivalent to the GMP Certificate.

AUTORIDADES REGIONALES DE SALUD

Through Ministerial Resolution No. 730-2026/MINSA, published on August 25, 2026, Health Directive No. 169-MINSA/DIGESA-2026 was approved, establishing provisions regarding the technical suitability of Regional Health Authorities for the implementation and verification of the certification of the General Principles of Hygiene (GHP) of the Codex Alimentarius.

The Directive establishes the conditions that Regional Health Directorates (DIRESA), Regional Health Management Offices (GERESA), or equivalent entities must meet to obtain and maintain the technical suitability required to grant GHP certification to establishments engaged in the manufacture, storage, and processing of processed foods, as well as collective food service establishments. DIGESA, through the Directorate of Certifications and Authorizations (DCEA), assesses the technical suitability of regional authorities and issues the corresponding favorable opinion, which is valid for two (2) years and may be renewed.

The Directive is mandatory for DIRESA, GERESA, or equivalent regional entities that perform GHP certification functions.

ELECTRONIC NOTIFICATIONS

Through Superintendence Resolution No. 000147-2026-SUSALUD/SUP, published on August 29, 2026, the “Directive Establishing the Guidelines, Schedule, Technical and Administrative Criteria for the Mandatory Notification Procedure through Electronic Mailboxes and the Assignment of Electronic Mailboxes at the National Superintendence of Health (SUSALUD)” was approved.

The Directive implements the provisions of the Regulations on Mandatory Notification through Electronic Mailboxes of SUSALUD, approved by Supreme Decree No. 009-2026-SA, and aims to establish the guidelines applicable to the implementation of electronic notifications through electronic mailboxes in the administrative proceedings and actions carried out by such entity.

FOOD SAFETY OF INDUSTRIALLY PROCESSED FOODS

Draft Bill No. 12262/2025-CR, which proposed amendments to Articles 88, 90, 91, 92, 93, and 95 of the General Health Law regarding food safety controls for industrially processed foods, was not approved, and the current regulatory framework remains unchanged.

The proposal had received a favorable opinion from the Health and Population Commission since May 2026 and sought to replace the “sanitary certification” and “sanitary import authorization” regimes introduced by Legislative Decree No. 1290 with prior assessment procedures subject to negative administrative silence and a predetermined four-year validity period. However, Congress concluded the 2021–2026 parliamentary term without debating the bill in plenary session.