Life Sciences Newsletter - June 2026
Themes
BUREAUCRATIC BARRIERS
INDECOPI Declares the Two-Year Validity Period of the HACCP Plan Certificate an Illegal Bureaucratic Barrier
Through Resolution No. 0184-2026/SEL-INDECOPI, published on June 10, 2026, the imposition of a fixed two-year validity period for the Official Technical Validation Certificate of the “Hazard Analysis and Critical Control Points Plan” (HACCP Plan) was declared an illegal bureaucratic barrier.
This bureaucratic barrier is established under the following regulations issued by the Ministry of Health:
- Article 58-A of the “Regulations on the Sanitary Surveillance and Control of Food and Beverages”, approved by Supreme Decree No. 007-98-SA; and
- Article 33 of the “Sanitary Standard for the Implementation of the HACCP System in the Manufacture of Food and Beverages”, approved by Ministerial Resolution No. 449-2006-MINSA.
The Resolution states that MINSA violated Article 42 of the Consolidated Text of the General Administrative Procedure Law, which provides that authorizing titles have an indefinite term of validity, unless a specific validity period is established by law or legislative decree.
It should be noted that the Resolution does not declare the illegality of the validity periods established in specific administrative acts issued to date.
INDECOPI Declares the Application of Negative Administrative Silence in the HACCP Plan Certificate Procedure an Illegal Bureaucratic Barrier
Through Resolution No. 209-2026/SEL-INDECOPI, published on June 12, 2026, the classification of Procedure No. 35 of the Ministry of Health (MINSA) Single Text of Administrative Procedures (TUPA) as subject to negative administrative silence was declared an illegal bureaucratic barrier. This procedure relates to the Official Technical Validation Certificate of the “Hazard Analysis and Critical Control Points Plan” (HACCP Plan).
The Resolution states that MINSA failed to provide sufficient justification for applying negative administrative silence when approving such procedure, as required under Article 8(4) of Supreme Decree No. 079-2007-PCM and Law No. 29060.
Furthermore, it establishes that negative administrative silence is an exceptional mechanism that may only apply when the applicant’s request could significantly affect the public interest, which must be duly substantiated by the authority at the time the procedure is approved.
INDECOPI Declares Requirements Applicable to Hyperbaric Chambers Illegal Bureaucratic Barriers
Through Resolution No. 0086-2026-CEB-INDECOPI, published on June 25, 2026, several requirements established under the Regulations of Pharmaceutical Establishments, approved by Supreme Decree No. 014-2011-SA, were declared illegal bureaucratic barriers.
The decision concerns requirements imposed for the manufacture and commercialization of hyperbaric chambers, including the following:
- The obligation to have independent and physically separate manufacturing and storage areas.
- The requirement to have technical personnel responsible as Head of Production, Head of Quality Assurance, and Head of Quality Control.
- The requirement to have a pharmaceutical chemist professional responsible for the quality assurance system and the production and quality control areas.
INDECOPI determined that such requirements constitute illegal bureaucratic barriers, as the Ministry of Health lacks express legal authority to impose them.
DRUG INTERCHANGEABILITY
Draft Amendment to the Regulation
Through Ministerial Resolution No. 548-2026/MINSA, published on June 5, 2026, the publication of the draft Supreme Decree amending the Regulation on Drug Interchangeability, approved by Supreme Decree No. 024-2018-SA, was authorized.
The proposal seeks to update the drug interchangeability framework through the amendment and incorporation of new regulatory provisions.
The main proposed changes include the following:
- The participation of manufacturing laboratories (domestic and foreign) certified by the National Medicines Authority (ANM) in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) is incorporated, as well as that of foreign centers certified or recognized by highly stringent regulatory authorities, expanding both the types of authorized entities and the activities they may perform (including in vitro studies and pharmaceutical comparability assessments).
- The draft regulation allows the use of comparator products sourced from international lists (WHO), highly stringent regulatory authorities, or authorities listed by WHO, even when such products are not marketed in Peru.
- Studies conducted by centers certified or inspected by international authorities are expressly recognized, including authorities listed by WHO as WHO-Listed Authorities (WLA) and authorities from countries with highly stringent health surveillance systems.
- It is established that medicines included in the National Essential Medicines Formulary (PNUME) will not be required to submit therapeutic equivalence studies when the authority has not designated a reference product (RP), provided that no safety or efficacy concerns exist.
The Ministerial Resolution establishes a period of ninety (90) calendar days to submit comments or observations regarding the draft regulation.
GOOD MANUFACTURING PRACTICES (GMP)
Update of the List of Equivalent Documents
Through Directoral Resolution No. 063-2026-DIGEMID-DG-MINSA, published on June 12, 2026, the “List of Documents Considered Equivalent to the Good Manufacturing Practices Certificate” was approved.
The regulation updates the current list and repeals Directoral Resolution No. 059-2022-DIGEMID-DG-MINSA by amending its Annex, which contains the list of documents accepted as equivalent to the GMP certificate. Through this regulation, new documents are recognized as equivalent to the GMP certificate within the framework of marketing authorization and importation of pharmaceutical products.
IMMUNIZATIONS
Technical Health Standard Establishing the National Immunization Schedule
Through Ministerial Resolution No. 561-2026/MINSA, published on June 13, 2026, NTS No. 246-MINSA/DGIESP-2026, “Technical Health Standard Establishing the National Immunization Schedule”, was approved.
The Technical Health Standard establishes the national immunization schedule, as well as the technical criteria for the planning, scheduling, implementation, monitoring, supervision, and evaluation of such interventions. It also provides that the State shall guarantee the supply and distribution of vaccines throughout the national territory.
Compliance with this regulation is mandatory for all public and private healthcare establishments that carry out immunization activities.
DONOR AND TRANSPLANT ESTABLISHMENTS
Amendment to the Technical Health Standard (NTS)
Through Ministerial Resolution No. 539-2026/MINSA, published on June 3, 2026, the amendment to the “Technical Health Standard for the Accreditation of Donor and Transplant Centers” was approved.
The regulation amended the technical and administrative provisions related to the accreditation process of Donor and Transplant Centers, including clarifications regarding requirements, evaluation criteria, infrastructure conditions, and operational capabilities necessary for the provision of these services.