Regulatory Changes to the Regulation of Pharmaceutical Establishments: Key Provisions of Supreme Decree No. 008-2025-SA
Prepared by Carolina Núñez – Associate Consultant in Quality Assurance and Regulatory Intelligence
On Friday, June 13, 2025, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) convened stakeholders from the pharmaceutical sector to present the scope of Supreme Decree No. 008-2025-SA, which modifies key articles of the Regulation of Pharmaceutical Establishments (Supreme Decree No. 014-2011-SA). The aim of this update is to modernize administrative procedures, strengthen inspection and oversight mechanisms, and streamline technical certification requirements.
The regulation introduces amendments to Articles 23, 94, 110, 123 to 129, 135(d), and 137. It also includes complementary provisions establishing transitional terms and deadlines for establishments undergoing administrative procedures.
Below is a summary of the main topics addressed by the national regulatory authority:
Temporary and Permanent Closures: Amendments to Article 23
The maximum period for the temporary closure of a pharmaceutical establishment has been extended from 6 to 12 months, counted from the date reported to the Health Authority. If the establishment does not resume operations within this period, automatic permanent closure will apply.
During temporary closure, if the establishment retains product stock, compliance with Good Storage Practices must be ensured by the Technical Director and legal representative. For closures due to safety measures, the same 12-month period applies. If issues are not resolved within this timeframe, permanent closure will be enforced.
Technical Staff Requirements in Sanitary Product and Medical Gas Laboratories (Article 94)
A more flexible technical framework has been established for laboratories producing sanitary products and medicinal gases. In these cases:
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The Technical Director may also serve as head of quality assurance and production.
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The Quality Assurance Head may assume the responsibilities of quality control.
The regulation outlines minimum experience, training, and technical competency requirements for those in supervisory roles, maintaining operational independence under the supervision of the Technical Director.
Certification of Good Practices: Validity, Deadlines, and Simplification (Articles 110, 123 to 129)
The decree introduces substantial changes to the certification procedures for Good Pharmacovigilance Practices and Pharmaceutical Office Good Practices:
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Validity is now indefinite, eliminating the previous three-year renewal requirement.
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Certification decisions must be issued within 45 calendar days.
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Certification requests may be submitted by sworn statement, with no additional prior documentation.
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Establishments with valid certifications may request an updated certificate with indefinite validity from the Health Authority at no extra cost.
It is worth noting that pharmacovigilance certification remains voluntary for establishments that are not holders of marketing authorizations or sanitary registration certificates.
Inspections: Responsibilities and Enforcement (Articles 135 and 137)
New provisions were introduced to address inaccessibility or obstruction during inspections:
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If the establishment is closed at the time of the visit, a record will be left, and a new date scheduled. If still closed on the second attempt, a temporary closure will be imposed as a safety measure.
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If an inspection is interrupted or prevented without justified cause, temporary closure will also apply. Reopening is contingent upon completion of the inspection.
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Justified cases of force majeure or unforeseen circumstances are exempted.
Transitional Provision: Regulatory Adjustment
A transitional clause applies to establishments under temporary closure for over a year at the time of entry into force of the decree. These must submit a request to resolve outstanding issues within 45 calendar days. Failure to do so will result in definitive closure.
Final Considerations
The enactment of Supreme Decree No. 008-2025-SA represents a significant procedural and technical update for pharmaceutical establishments in Peru. The measures adopted directly affect processes related to closures, technical management, inspections, and certifications, aiming to strengthen the national regulatory system while facilitating administrative simplification.
The full text of the changes is available in the official decree and annexes, and through the official channels of the National Authority of Pharmaceutical Products, Medical Devices, and Health Products.