INDUSTRIAL USE OF HEMP
Law 32195, “Law for the Agricultural Development of Hemp for Agricultural and Industrial Use” was published, corrected by an errata.
This law marks an important milestone in the commercialization of food for human and animal use, as well as cannabis-based cosmetics. It not only provides a legal framework for the production and commercialization of industrial and agricultural hemp but will promote its use as a key resource for innovative sectors.
Some highlights of the law:
This law provides a legal framework for the production and commercialization of industrial hemp and its products.
For further information: https://www.estudiorodrigo.com/life-sciences-producto-legal-ley-del-canamo/
Resolution 1977 of the National Animal Health and Quality Service (SENACSA) of Paraguay authorized the registration, processing, import, export and distribution of animal feed containing hemp (THC concentration less than 0.05%).
The following activities were regulated:
LABELING REGULATIONS
By means of Resolution 2458, the General Secretariat of the Andean Community extended the entry into force of the “Andean Technical Regulation for the Labeling of Cosmetic Products” until December 17, 2025.
Consequently, the labeling of cosmetic products must continue to comply with the provisions established in Decision 516.
RESEARCH PRODUCT DISPENSATION UNIT
Ministerial Resolution 883-2024/MINSA approved the “Technical Health Standard that regulates the Dispensing Unit for Clinical Trials” (NTS 219-MINSA/DIGEMID-2024).
The NTS regulates the activities of reception, conservation and/or storage, repackaging and/or preparation, return, control and inventory and archiving of records related to the product under investigation. It will come into force on August 20, 2025.
For further information: https://www.estudiorodrigo.com/alerta-life-sciences-diciembre-2024-2/
MEDICAL RECORDS
The draft amendment to the Regulation of Law 30024, Law that creates the National Registry of Electronic Medical Records (Supreme Decree 009-2017-SA) was published.
These amendments seek to promote scientific research in health through access to clinical data, obtained from electronic medical records, duly dissociated and respecting the fundamental rights of patients, especially the protection of their personal data.
It also establishes procedures so that academic institutions can access this information safely and exclusively for research purposes, promoting innovation and technological development in the health sector.
The deadline for submitting comments on the draft amendment is January 7, 2025. Comments should be sent to the email cpublicaRENHICE@minsa.gob.pe.
ONCOLOGY COVERAGE
Ministerial Resolution 876-2024/MINSA approved the “Technical Health Standard on access to oncology coverage” (NTS 218-MINSA/DGIESP-2024) which regulates promotion, prevention and recovery of oncology coverage:
GUIDELINES FOR THE DECLARATION OF A STATE OF EMERGENCY
Ministerial Resolution 845-2024-MINSA approved the “Technical Document: Guidelines for the formulation and evaluation of the declaration of a health emergency and its corresponding action plan”.
These guidelines establish mandatory rules for entities to formulate a request for the declaration of a health emergency. Also, mandatory rules are established for the Technical Commission on Health Emergencies of MINSA to evaluate the request for the declaration of a health emergency and issue an opinion.
FARMAMINSA
Law 32176, “Law for the strengthening and implementation of FARMAMINSA public pharmacies at the national level” was published.
This law recognizes the “FARMAMINSA” public pharmacies, which were created by Ministerial Resolution No. 100-2024/MINSA.
The Minsa is given budgetary powers to finance the “FARMAMINSA” public pharmacies.
COMPLEMENTARY LIST
Ministerial Resolution 837-2024/MINSA approved the complementary list of biological products used as antivenins for the treatment of accidents caused by poisonous animals.
GRANTING OF GMP CERTIFICATE
Ministerial Resolutions No. 853, 852, 851, 848, 844, 835-2024/MINSA authorized Digemid officials to travel to laboratories in Argentina, China, Poland and Vietnam to carry out inspections in order to grant GMP certification.
MINSA BUDGET FOR INVESTMENT PROJECTS
Law 32185 approved the “Annual Expenditure Budget for Fiscal Year 2025” for the amount of more than S/250 billion. The Ministry of Health was allocated more than S/1500 million to carry out investment projects, an amount higher than 2024, which was S/1314 million.
