LIFE SCIENCES NEWSLETTER
GENERIC MEDICINES
Supreme Decree No. 020-2024-SA amended the regulations on pharmaceutical establishments and health registrations under Law No. 32033.
Some of the main modifications are:
- Drugstores, laboratories, pharmacies and drugstores must report to Digemid, the price of the commercial offer of medical devices.
- Drugstores and pharmacies will offer generic drug alternatives in International Nonproprietary Names with the same active ingredients, concentration and pharmaceutical form, as well as the prices, without inducing to acquire any of such alternatives.
- Drugstores and pharmacies may not offer medical consultations, medical offices, clinical analysis, collection of samples for clinical laboratory, medical campaigns, tastings or locutories and other activities not expressly authorized for such establishments.
- Drugstores and pharmacies must keep available the essential generic drugs in International Nonproprietary Names (INN) in at least 30% of each item of their offer of brand name drugs included in the List of essential generic drugs in INN approved by the Ministry of Health. Micro-companies are excluded.
- Advertising of pharmaceutical products and medical devices without medical prescription must contain the International Nonproprietary Name (INN), the name of the product, the dosage, concentration or pharmaceutical form of the product, as the case may be.
- Advertising in virtual or digital media of pharmaceutical products and medical devices without medical prescription is subject to the provisions established for audiovisual and printed media.
NATIONAL FORMULARY – PNUME
Ministerial Resolution No. 721-2024/MINSA approved the modification of the Single National Essential Drug Formulary (PNUME).
This modification establishes that:
- Digemid will define the levels and categories of health facilities where drugs and biological products on the PNUME list may be used.
- It specifies the requirements to be met by the establishments and the technical criteria necessary to guarantee their rational and safe use, and the appropriate prescription of the drugs.
MEDICAL DEVICES
Ministerial Resolution No. 734-2024/MINSA published the draft Regulation for the registration, control and sanitary surveillance of medical devices.
Comments may be sent through the e-mail address: webmaster@minsa.gob.pe, during a period of ninety (90) calendar days, starting on October 27, 2024.
CANCER REGULATION
Supreme Decree No. 018-2024-SA modified the Regulation of the National Cancer Law (Law No. 31336) approved by Supreme Decree No. 004-2022-SA.
The amendment includes changes in 8 articles and a final complementary provision that refers to the following points:
- Differentiated procurement of pharmaceuticals and devices.
- Biomedical equipment and technological replacement for cancer prevention and control.
- Tumor bank
- High-cost products
- Health promotion and cancer prevention actions
MEDICAL CANNABIS
MINSA made a call for quotation for the “Standardized Cannabis Sativa Extract: CBD 50MG/ML +/- 10% + THC < 1% and > 0.100%”, to supply the Institutional Pharmacy of the Digemid.
The deadline for the submission of quotations and consultations was September 2024.
BEST PRACTICES – BPM
Ministerial Resolutions No. 709, 704, 703, 692, 691, 668, 653, 652, 651, 650 -2024/MINSA authorized Digemid officials to travel to laboratories in Argentina, Brazil, Colombia, India, Mexico, Panama and Uruguay to carry out GMP inspections.
By means of Official Communication No. 1933-2024-DIGEMID-DG-DICER-ELAB/MINSA, the lists of laboratories pending GMP certification by Digemid were published.
