AMENDMENT TO THE REGULATIONS FOR PHARMACEUTICAL ESTABLISHMENTS
Supreme Decree 008-2025-SA amended the Regulations for Pharmaceutical Establishments. This amendment affects the following matters related to the regulation of pharmaceutical establishments:
DRAFT AMENDMENT TO THE REGULATIONS FOR PHARMACEUTICAL ESTABLISHMENTS
Ministerial Resolution 399-2025-MINSA published the draft Supreme Decree amending Article 43 and Annex 01 of the Regulations for Pharmaceutical Establishments.
This amendment prohibits pharmacy technical personnel from dispensing prescription pharmaceutical products or offering users alternatives to prescribed medications. It also allows the hiring of technical personnel with a certified pharmacy technician certificate.
MINSA received comments on the draft until June 27, 2025.
PRODUCTS AND SERVICES PROHIBITED FROM MARKETING IN PHARMACIES
Through Ministerial Resolution 419-2025/MINSA, the draft ministerial resolution was published approving the list of products and services prohibited from being marketed and/or provided in pharmacies, drugstores, pharmacies in health facilities, and first-aid kits, within the framework of the provisions of Article 46 of Law 29459, the Law on Pharmaceutical Products, Medical Devices, and Sanitary Products.
This bill would repeal the «List of Complementary Products and Services Not Authorized in Pharmacies, Drugstores, Pharmacies in Health Facilities, and First-Aid Kits,» approved by Directorial Resolution 006-2015-DG-DIGEMID-MINSA.
The Ministry of Health will receive comments and recommendations on the bill until Monday, July 7, 2025, via email at webmaster@minsa.gob.pe.
TARTRAZINE IN FOOD
Communication 6-2025-DIGESA/MINSA indicates that all products containing tartrazine must declare the phrase «CONTAINS TARTRAZINE» and «recommended use of up to 7.5 mg/kg weight/day» at the end of the ingredient list.
DIGESA granted a one-year deadline, which expires on June 21, 2026, to allow for the depletion of stocks of labels (labeling) that do not contain this declaration.
Finally, DIGESA urged companies that manufacture foods containing tartrazine to gradually replace tartrazine with other additives listed in the Codex Alimentarius, especially in foods intended for children.
DRAFT REGULATIONS FOR THE NEW ACCELERATED REGISTRATION PROCEDURE FOR PHARMACEUTICAL PRODUCTS
Through Ministerial Resolution 403-2025-MINSA, the draft Supreme Decree was published regulating the provisions of Law 32319, which establishes measures to facilitate access to medicines and biological products registered in high-level health surveillance countries for the treatment of rare and orphan diseases, cancer, and other diseases.
This draft provides details of the requirements that must be met to carry out the accelerated procedure for granting health registration for medicines and biological products previously authorized in high-level health surveillance countries (HHSCs), in accordance with the provisions of Law 32319. It also establishes the regulatory conditions that would govern this type of authorization.
Finally, this bill seeks to clarify the status of health registrations granted under Article 9 of Law 29698 and the transition of health registrations for medicines and biological products approved under other regulations that could in the future opt for the accelerated authorization offered by Law 32319.
The Ministry of Health (MINSA) will receive comments on the bill until September 12, 2025, via email: webmaster@minsa.gob.pe.
MODIFICATION OF DECISION 833
Decision 943 modified the requirements for issuing the NSO code established in Decision 833, «Harmonization of Legislation on Cosmetic Products.»
The modifications consist of:
DIGEMID GRANTS GMP CERTIFICATE
Ministerial Resolutions 381, 382, 387, 429, and 430-2025/MINSA authorized travel for DIGEMID officials to conduct inspections at laboratories in Argentina, Bangladesh, India, Mexico, and the Dominican Republic for the purpose of granting GMP certification.
COMPLEMENTARY LIST TO PNUME
Ministerial Resolution 393-2025-MINSA approved the Complementary List of Medications for Mental Health Treatment for PNUME.
REGULATIONS OF THE LAW PROMOTING ORGAN DONATION
Supreme Decree 009-2025-SA approved the Regulations of Law No. 31756, the Law promoting the donation of human organs and tissues for transplantation for therapeutic purposes.
This regulation seeks to clarify the definition of presumed donation. It establishes that every person is presumed to be a donor, unless otherwise declared. It details the procedure for declaring the will not to donate organs and its revocation before the RENIEC (National Institute of Registered Nurses), as well as the procedure regarding the declaration of donation made by family members and the donor’s last will and testament.
It also details the procedure that healthcare facilities must follow with the General Directorate of Donations, Transplants, and Blood Bank (DIGDOT) to obtain accreditation as a donor and/or transplant facility.
Finally, the creation of «procurement units» (their functions and operating requirements are detailed) is established in all facilities with UPSS Intensive Care and UPSS Emergency units. These units will be registered in the National Donation and Transplant Information System (SINDOT).
DIGITAL AGENDA FOR THE HEALTH SECTOR TOWARDS 2030
Supreme Decree 005-2025-SA approved the Digital Agenda for the Health Sector toward 2030. This document sets forth the guidelines, strategy, and actions that the Ministry of Health will deploy to guide the digital transformation process of the Peruvian health system. Among the most relevant guidelines and strategies are the following:
1. Strengthening the Secure Digital Health Ecosystem and its Governance
Promoting the creation of a digital governance model that guarantees cybersecurity.
Establishing mechanisms for digital citizen participation, online accountability, and quality and digital security standards.
Coordinating interoperability processes between public entities and private institutions in the health sector.
2. National Deployment of the Electronic Health Record (EHR) and Telehealth
Seeks to consolidate the EHR as the only valid, integrated, and interoperable digital document among all public and private healthcare providers.
Establishes the need for data standardization, electronic prescriptions, and digital connectivity.
Strengthens the provision of remote healthcare services based on principles of equity and a territorial and intercultural approach.
3. Improves the reliability and availability of information for decision-making.
Establishes policies for data quality, anonymization, and the ethical and secure use of sensitive data through the Single Health Information Repository (REUNIS).
Promotes data analytics, Big Data, and data science for decision-making, population monitoring, and public policy.
4. Promoting the Maturity, Development, and Innovation of Health Technology
Incentivizes research, innovation, and deployment of emerging technologies: artificial intelligence, robotics, IoT, and machine learning.
Promotes innovation initiatives in health with the collaboration of academia and the private sector.
SUSPENSION OF DECISION 483
Decision 942 extended the suspension of the application of Decision 483, «Standards for the Registration, Control, Marketing, and Use of Veterinary Products,» until June 24, 2027.
Likewise, it was ordered that the Andean Technical Committee for Agricultural Health (COTASA), through the Group of Specialists in Veterinary Products, prepare the Draft Decision to modify or replace Decision 483 and its Technical Manual. If a project is not prepared by April 30, 2026, no further extensions of the suspension of Decision 483 will be granted, and the Decision will apply from June 24, 2027.
AMENDMENT TO DECISION 839
Decision 943 amended Decision 839 to extend the revaluation period for all Chemical Pesticides for Agricultural Use (PQUA) registered prior to the entry into force of Decision 436 until June 25, 2028.
ONCOLOGICAL FORGETTING LAW
Law 32357, the Oncological Forgetting Law in the Contracting of Health Services and Insurance, was published.
This law establishes that any person who has overcome an oncological condition has the right to contract health services or insurance without considering their history as a cancer patient. Once five years have passed since the end of treatment, all clauses in the contracting of health services and insurance that establish otherwise will be void.
COMPETENCIES OF THE HEALTH EPIDEMIOLOGIST
Ministerial Resolution 380-2025-MINSA approves the Technical Document: Competency Profile of the Health Epidemiologist. This document establishes the competency profile of all epidemiologists, including those at the IPRESS level.
