GENERIC DRUGS
Law No. 32033, which guarantees and promotes access to and use of generic medicines in the International Nonproprietary Name (DCI), was published in the Official Gazette El Peruano and strengthens the regulation of pharmaceuticals and medical devices for the benefit of patients and users.
The most relevant provisions are:
The Ministry of Health (MINSA) will annually approve a list of generic essential drugs in ICD to be offered by pharmacies and private pharmacies. Until a new listing is approved, the one approved by the Ministerial Resolution Ministerial Resolution No. 220-2024-MINSA will remain in force.
Private pharmacies must inform the consumer if the products they offer are manufactured or distributed by a company linked to the establishment at the time of sale.
Article 33 of Law No. 26842, General Health Law, is amended to provide that the supply of medicines in private health services must offer all alternatives: generic drugs in ICD, brand-name generic drugs and, where these options do not exist, innovative drugs. This applies to all sales channels, including virtual or digital.
Articles 27, 28, 30, 32, 39 and 46 of Law No. 29459 Law on Pharmaceutical Products, Medical Devices and Medical Devices are amended:
Private pharmacies and drugstores are required to keep available at least 30% of their supply of branded medicines in the alternative of generic essential drugs from the list of essential generic medicines approved by the Ministry of Health. This obligation is limited to those products that are part of its own brand name product offer, by item and not by number of units in stock. This obligation does not apply to natural or legal persons qualified as micro-enterprises.
Priority is given to the sale of generic medicines at the dispensary in pharmacies and private pharmacies.
The labelling of products must indicate whether they are manufactured by a laboratory linked to the establishment, an obligation that will come into force in 180 days.
Advertising for products sold without a medical prescription may be carried out if the purpose is to inform the consumer of the selling price. The advertising may include comparative information in terms of quality, price and relevant technical information.
It is forbidden to provide any kind of incentive for the pharmacist or any worker in pharmacies and pharmacies to induce the consumer to purchase certain brands The Commission has already taken a number of initiatives to improve the quality of medicines.
AGREEMENT ON TECHNICAL COOPERATION BETWEEN MINSA AND PAHO
The validity of Convention No. 2-2012/MINSA was extended to include «Technical Cooperation Agreement between the Pan American Health Organization (PAHO) and MINSA for the purchase of vaccines, syringes and other related inputs», until 31 December 2024.
Accordingly, MINSA will continue to purchase vaccines, syringes and other related supplies through the PAHO Revolving Fund.
TYPE 1 DIABETES
Ministerial Resolution No. 356-2024/MINSA adopted the «Technical Guide: Clinical Practice Guide for the Diagnosis and Treatment of Type 1 Diabetes Mellitus in Children, Adolescents and Adults».
This guide sets out technical standards for standardizing the criteria for the prevention, diagnosis, treatment and monitoring of DM-C1 in Peru, both in the health facilities of MINSA and the regional governments.
DANGEROUS SUBSTANCES REGULATION COMES INTO FORCE
The Digesa through the Communiqués No. 12-2024-DIGESA/MINSA and 13-2024-DIGESA/MINSA, has specified that the Supreme Decree No. 31-2023-SA Regulation and Control of Dangerous Substances for Domestic, Industrial and/or Public Health» will come into force on 1 June 2024.
It has also been clarified that procedures initiated before the entry into force of this Supreme Decree will be governed by the previous rules and not by the new regulations.
For more information about the content of the new regulation: Regulation and control of dangerous substances for domestic, industrial and/ or public health
ENRICHMENT OF RICE
By Supreme Decree No. 008-2024-SA, the Regulation of Law No. 31348 was adopted, Law proposing the enrichment of rice in Peru, which establishes measures to ensure the quality of fortified rice produced by companies in the sector.
In order to ensure that the fortified rice line meets minimum quality standards, a certificate issued by laboratories accredited by INACAL, IACC or ILAC is required. This certificate is required to apply for the health registration of the food. Similarly, imported fortified rice must meet these quality requirements.
As for labelling, it is required that it be clearly indicated that the rice is fortified and that the content of micronutrients according to established standards be detailed.
DIGESA is the entity responsible for auditing and sanctioning compliance with minimum quality requirements. Holders or applicants for authorisations relating to fortified rice have one year to adapt to the provisions of this regulation.
DIGEMID
DATA SHEET ON GEL REPELLENT
By Ministerial Resolution No. 302-2024/MINSA was incorporated into the «Technical Health Standard for the Manufacture of Pharmaceutical Preparations» (NTS No. 122-MINSA/DIGEMID-V.01) the Technical Data Sheet for the preparation of a standardised pharmaceutical preparation called «gel repellent».
BPM CERTIFICATION – FOREIGN LABORATORIES
By Ministerial Resolutions Nos. 304, 315, 316, 318, 340 and 341-2024/MINSA, the travel of Digemid officials was authorized to carry out inspections of laboratories in Argentina, Brazil, China, Colombia, and India. The purpose of these inspections is to award BPM certification.
ORGANIC PRODUCTION
By means of the Executive Resolution No. D000024-2024-MIDAGRI-SENASA-DIAIA, the deadline for certification bodies of organic production with current authorisation to comply with the requirements set out in the Regulation was extended until 8 February 2025 Certification and Control of Organic Production.
RARE OR ORPHAN DISEASES AND ONCOLOGY
By Ministerial Resolution No. 373-2024/MINSA, the draft of the Supreme Decree regulating the health registration of pharmaceutical products for the treatment of rare or orphan diseases and oncology was published, Article 9 of Law No. 29698, which declares the treatment of persons suffering from rare or orphan diseases to be of national interest and priority attention.
The draft regulation seeks to develop the provisions of article 9 of Law No. 29698, which provides for the health registration of pharmaceutical products, including biological products, indicated for the treatment of rare or orphan diseases and oncology, provided that they are registered in any high surveillance health country, without requiring any technical or medical requirements other than the accreditation of such prior registration.
Article 9 also provides that:
– The safety and efficacy information submitted by the holders of the pharmaceutical products shall be the same as that which supported the corresponding registration in the country of high surveillance.
– The Digemid shall decide on the application for registration or re-registration in the health registry, within a period not exceeding 45 calendar days, subject to positive administrative silence, under the responsibility and sanction of the official concerned.
During the next three months (until 30 August 2024), public or private entities, as well as citizens in general, The European Commission has published a report on the webmaster@minsa.gob.pe.
GLUTEN-FREE FOODS
Ministerial Resolution No. 314-2024/MINSA published the draft Regulation of Law No. 31881, which promotes information on gluten-free foods.
This draft regulation regulates the use of «legends» such as «gluten-free» and «symbols» such as a barred spike on labels and advertising for industrialized foods, ensuring that they are visible and do not interfere with mandatory information.
Digesa is the authority responsible for authorising the use of these symbols, both for domestic and imported products, and it is required to meet two key requirements to obtain this approval: that the food comes from establishments certified with Good Manufacturing Practices (GMP) and laboratory tests show less than 20 mg/kg of gluten. The authorization is indeterminate, subject to control by Digesa.
The regulation also states that manufacturers and importers are responsible for complying with these standards and can be sanctioned by the Digesa or the Indecopi for non-compliance. MINSA will receive comments on the project until August 8, 2024, through webmaster@minsa.gob.pe.
