On November 8, 2023, Law N° 31919 was published, which modified Article 10 of the Law for the Promotion of Healthy Eating for Children and Adolescents (Law N° 30021).
The amendment established the possibility of including the octagons on stickers on the labels of imported products, as well as on products manufactured by micro and small enterprises (MYPE). In fact, this had already been contemplated in the Advertising Warnings Manual, through an exception to the Law that temporarily allowed the use of stickers on those products, and, very recently, through Supreme Decree N° 017-2023-SA.
The novelty of Law N° 31919 is given by the fact that it establishes that the adhesives used to place the Advertising Warnings must comply with the quality standards established by the National Institute of Quality (Inacal). For this purpose, the Law has granted a term of 240 working days for Inacal to approve a Peruvian Technical Standard for adhesives for the food industry that guarantees their difficult removal.
Finally, it is established that suppliers will have a term of 180 calendar days, counted from the entry into force of the Technical Standard for adhesives, to comply with Law N° 31919.
By means of Supreme Decree N° 030-2023-SA, the 5-year term, provided for in the fourth Final Complementary Provision of the Regulation that regulates the interchangeability of medicines (Supreme Decree N° 024-2018-SA), which expired on September 15, 2023, was extended to three more years for the holders of the registration of multi-source medicines that do not require in vivo and in vitro studies to demonstrate that they are interchangeable, to support before the Authority that they are interchangeable, by equivalence in the pharmaceutical form or in their formulation, with the reference products.
Through Ministerial Resolutions N° 1084-2023/MINSA, No. 1085-2023/MINSA and N°1086-2023/MINSA, Digemid officials were ordered to travel to Brazil, Colombia and Uruguay to conduct audits to verify compliance with GMP.
By means of Ministerial Resolution N° 1101-2023/MINSA, the entry into force of the “Technical Document: Manual of Good Pharmacy Office Practices” (Ministerial Resolution N° 554-2022/MINSA) was extended for six (6) additional months. 554-2022/MINSA), which establishes the technical criteria and the minimum and mandatory healthy conditions to be met by pharmacies, apothecaries and pharmacies of public and private health establishments related to storage, dispensing, pharmacovigilance and, if applicable, pharmacotherapeutic follow-up, distribution and transportation of pharmaceutical products, medical devices and health products, in order to obtain the corresponding certification.
Likewise, the period for the orientation audits to report on the correct compliance with the “Technical Document: Manual of Good Pharmaceutical Office Practices” was extended until November 29, 2024. After this date, audits will be carried out to verify compliance.
The Specialized Chamber on Elimination of Bureaucratic Barriers of the INDECOPI Court established that the 6-month and 3-year terms of validity of the Certification of Good Pharmaceutical Office Practices, contained in article 127 of the Regulation of Pharmaceutical Establishments (Supreme Decree 014-2011-SA), are illegal bureaucratic barriers, since they contravene article 42 of the Sole Ordered Text of Law 27444, Law of General Administrative Procedure.
Thus, these deadlines are no longer applicable, which means that the Certification of Good Pharmaceutical Office Practices has an undetermined term.
It is important to note that the fact that the term of the Certification is indefinite does not mean that it is not mandatory to have the corresponding Certification in order to operate as a pharmaceutical establishment, nor that the standards of Good Pharmacy Office Practices must not be complied with.
Communiqué No. 052-2023.
Ministerial Resolution N° 1104-2023/MINSA published the draft Administrative Directive that regulates the procedure for the destruction of pharmaceutical products.
The destruction procedure is mandatory for:
Pharmaceutical establishments that have in stock pharmaceutical products that are expired, deteriorated, contaminated or altered in appearance, adulterated or others with similar observations.
Digemid, Diris and Diresas in relation to products seized or confiscated within the control and healthy surveillance actions.
Sponsors or contract research organizations that perform or are linked to clinical trials on human beings in the national territory.
DRAFT: REGULATION OF THE ELECTRONIC TRANSACTION MODEL OF STANDARDIZED INVOICING DATA
By means of Superintendence Resolution N° 083-2023-SUSALUD/S, the Draft of a new “Regulation of the Electronic Transaction Model of Standardized Billing Data – Model TEDEF-IPRESS-IAFAS and TEDEF-SUSALUD” was published.
The proposed regulations establish within their scope of application the IAFAS and private IPRESS registered in SUSALUD that in the year prior to the submission of the information have carried out transactions that reach an average monthly billing, greater than or equal to twenty (20) UIT.
Ministerial Resolution N° 1035-2023/MINSA repealed the Updated National Vaccination Plan against COVID-19 (Ministerial Resolution N° 488-2021/MINSA) and its amendments (Ministerial Resolutions N° 809-2021/MINSA, N° 1352-2021/MINSA and N° 704-2022/MINSA). This repeal was carried out to systematize the current legislation concerning vaccination against COVID-19, since the only current technical standard on vaccination is Technical Health Standard No. 208-MINSA/DGIESP-2023 (Ministerial Resolution N° 863-2023/MINSA).
Among the topics covered by the new Technical Health Standard N° 208-MINSA/DGIESP-2023 are: vaccination points, distribution of vaccines, authorized vaccines, competent personnel to administer them, registration of the vaccinated, patient care, vaccine administration process, doses and vaccination periods by age or medical characteristics, cold chain, risk management in case of vaccine loss or unwanted symptoms, among others.
REPEALED: OBLIGATION TO REPORT TO SUSALUD ON PRICES
By means of Superintendence Resolution N° 077-2023-SUSALUD/S, Superintendence Resolutions No. 043-2020-SUSALUD/S and N° 057-2020-SUSALUD/S were repealed, which provide for the obligation of private IPRESS to submit information to SUSALUD on the sale prices of products, services and medical devices for prevention, promotion, diagnosis, treatment, rehabilitation, complementary or auxiliary services, within the framework of preventive and control actions against the risk of spreading COVID-19. This derogation is due to the culmination of the healthy emergency due to COVID-19.
