SINGLE NATIONAL FORMULARY OF ESSENTIAL MEDICINES
Ministerial Resolution Nº 633-2023/MINSA approved the new Single National List of Essential Medicines (PNUME) for the Health Sector and repealed the previous one, approved by Ministerial Resolution Nº. 1361-2018/MINSA.
The lists complementary to the PNUME of medicines for the treatment of the following diseases are maintained:
ARTIFICIAL INTELLIGENCE IN FAVOUR OF THE ECONOMIC AND SOCIAL DEVELOPMENT OF THE COUNTRY
Law Nº 31814 establishes the principles for the development and use of artificial intelligence, declares the national interest of emerging technologies and artificial intelligence to improve public services, education and health, among others.
It also provides that the Secretariat of Government and Digital Transformation is responsible for directing, evaluating and supervising the use and promotion of the development of artificial intelligence and emerging technologies.
Thus, the Secretariat for Government and Digital Transformation has the duty to carry out the following actions:
CONDITIONAL HEALTH REGISTRATION: NEW REGULATION FOR MEDICINES AND BIOLOGICAL PRODUCTS
Supreme Decree Nº 020-2023-SA approved the Regulation for the Conditional Health Registration of Medicines and Biological Products.
The purpose of this new regulation is to establish the provisions to regulate the conditional health registration of medicines and biological products with clinical studies in phase III, according to Article 8 of Law Nº 29459, Law of Pharmaceutical Products, Medical Devices and Health Products, modified by Law Nº 31091, and Article 19 of Decision 827 of the Andean Community.
The new regulation shall enter into force six (6) months after the day following its publication in the Official Gazette El Peruano. Its entry into force will repeal the previous Regulation on the same subject, approved by Supreme Decree Nº 019-2021-SA.
DIGEMID – DIGITAL COURT REGISTRY OFFICE WILL BE OPEN 24 HOURS A DAY
By means of a communiqué published on DIGEMID VIRTUAL, DIGEMID established that the opening hours of the Digital File Desk will be 24 hours a day, seven days a week, by virtue of Law Nº 31565, “Law that modifies Law Nº 27444, Law of General Administrative Procedure, in order to facilitate the reception of digital documents”.
It also set the working hours for the reception of documents by the virtual desk of parties, according to which the date of reception will be governed:
SANCTIONS FOR INFRACTIONS OF THE CLINICAL TRIALS REGULATION
Supreme Decree Nº 018-2023-SA approved the Regulation for the application of sanctions related to infractions of the Clinical Trials Regulation. Thus, the scale of sanctions to be imposed as a result of the commission of infractions due to non-compliance with the provisions established in the aforementioned Regulation is established.
ILLEGAL BUREAUCRATIC BARRIER: HEALTH RULES FOR RESTAURANTS AND RELATED SERVICES
By means of the publication in the Peruvian Official Gazette of Resolution Nº 0555-2022/CEB-INDECOPI, two rules contained in Article 6.3.1 of NTS Nº 142-MINSA/2018/DIGESA, Health Rules for Restaurants and Related Services, approved by Ministerial Resolution Nº 822-2018-MINSA, were constituted as illegal bureaucratic barriers:
Thus, both rules will be inapplicable with general effects, in favor of all economic agents and/or citizens affected by the imposition of the bureaucratic barriers declared illegal.
FOOD SAFETY – MODIFICATION OF LEGISLATIVE DECREE 1290
Law No. 31842 amended the second final complementary provision of Legislative Decree 1290, Legislative Decree that strengthens the safety of industrialized food and fishery and aquaculture products.
As a result of this modification, in the framework of the health authorization for micro and small enterprises granted by DIGESA, which is based on the Good Manufacturing Practices Programme, it states that “the technical standards and administrative procedures approved by the Health Authority contain regulations that will consider the special conditions of micro and small enterprises, such as the number of establishments, number of workers, amounts and volumes of sales and quantity of products per category, among others, as long as the health of people is not put at risk and the safety of the products is guaranteed”.
PROHIBITION OF THE ACTIVE INGREDIENT CHLORPYRIFOS
By means of the Directorial Resolution Nº 0032-2023-MIDAGRI-SENASA-DIAIA, it is prohibited, from 12 July 2023:
In addition, it prohibits, from 1 August 2024:
Finally, within ninety (90) working days after 1 August 2024, the holders of registrations of chemical pesticides for agricultural use containing the active ingredient Chlorpyrifos must proceed with the withdrawal from the market, final disposal and inform users about the measures taken with respect to these pesticides and products containing the active ingredient Chlorpyrifos.
REGULATION OF THE LAW ON PROTECTION OF PEOPLE FROM LEAD CONTENT IN PAINTS AND OTHER COATING MATERIALS
Ministerial Resolution Nº 710-2023/MINSA published the Draft Regulation of Law Nº 31182, Law that protects the health and physical integrity of people from lead content in paints and other coating materials. The purpose of this regulation is to regulate and control the concentration of lead in paints and other coating materials.
This regulation conditions the manufacture, import, distribution and commercialization of paints and other coating materials:
