LIFE SCIENCES NEWSLETTER
PHARMACEUTICALS
DRAFT – GENERIC DRUGS
Ministerial Resolution No. 470-2024/MINSA published the draft Supreme Decree that adapts and updates the Regulations of Law No. 29459, Law on Pharmaceutical Products and Medical Devices, within the framework of Law No. 32033, Law that guarantees and promotes access and use of generic drugs in International Nonproprietary Names (INN) and strengthens the regulation of pharmaceutical products and medical devices for the benefit of patients and users.
This draft proposes to modify the regulations on Pharmaceutical Establishments and Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Medical Devices.
For further information on the modifications established by Law No. 32033: Life Sciences Bulletin – May 2024.
BIOLOGICAL PRODUCTS – GUIDE
Through Communiqué No. 016-2024, DIGEMID informed that the “Guide that establishes considerations and criteria to be met in the procedures for registration and re-registration in the sanitary registry of biological products (GUI.DPF.PM2.03)” was approved, which clarifies the requirements to be met in the procedures for registration and re-registration in the sanitary registry of biological products.
CHEMICAL SUBSTANCES
DRAFT REGULATIONS TO LEGISLATIVE DECREE No. 1570
Ministerial Resolution No. 214-2024-MINAM published the Draft Regulations of Legislative Decree No. 1570, Legislative Decree that approves the Law of Integral Management of Chemical Substances.
The purpose of the Regulations is to develop and clarify the measures, requirements and procedures contained in Legislative Decree No. 1570.
The most relevant points of the Draft Regulation:
- Establishes new definitions, additional to those provided by Legislative Decree No. 1570.
- Clarifies the chemical substances that are excluded from the scope of application of Legislative Decree No. 1570.
- Defines the List of anticipated classification of hazards of chemical substances (in Annex 1 of the Draft Regulation).
- Develops the criteria, requirements and procedure for hazard classification, labeling and safety data sheet (SDS).
- Establishes the procedure for registration in the National Register of Chemical Substances (RENSAQ).
- Specifies the application of “specific measures for the reduction and management of risk to health and/or the environment”, to be carried out by drafts under the National Environmental Impact Assessment System (SEIA).
- It develops the framework for the elaboration and submission of “risk assessments of chemical substances for health and the environment”. Manufacturers and/or importers of “chemical substances of national interest” must prepare these assessments.
- Provides rules for the disposal or discard of chemical substances.
- Develops the framework for the collection, use and treatment of data or information related to chemical substances.
- Establishes the obligations of the actors involved in the management of chemical substances: users, manufacturers, importers, exclusive representatives abroad, distributors, traders, transporters and employers.
MEDICAL CANNABIS
INDUSTRIAL USES OF HEMP
The Congress of the Republic approved the Law for the agricultural development of hemp for industrial use. The law was sent to the President of the Republic, and its most relevant points are the following:
- It contemplates the industrial use of hemp in the manufacture of food products for human or animal consumption.
- It also applies to cosmetic products.
- It will be applied in construction and building materials, in the textile industry and in any other form of transformation and industrialization, manufacture or production complying with the norms established by the competent authority according to the level of industrialization of each sector.
- Everything related to hemp production and commercialization authorizations will be developed and clarified in the regulation of the law.
- The proposed law contemplates that the industrial use of hemp will require an authorization to manufacture and/or commercialize hemp-based products. Hemp production includes the following activities: production and commercialization of seeds and seedlings, sowing, harvesting, gathering, storage, transportation, distribution, import and export of hemp. This authorization will not be required for the elaboration and/or commercialization of derived or final products based on hemp.
- According to the law, hemp includes flowering or fruiting tops comprising seeds, cuttings, plants and their parts (stems, leaves, flowering tops or roots), either in biomass or in cultivation of the plant of the cannabis genus whose THC content, including isomers, salts and acid forms, is less than 1% in dry weight.
- Articles 296-A and 299 of the Penal Code, DL 635 are modified: i) Those who have authorization for the production of hemp for industrial use are excluded from the penalties for cultivation of cannabis sativa; ii) Possession of hemp for industrial use is excluded from penalties, provided that the natural or legal person has the authorization issued by the competent authority.
BEST PRACTICES
BPM CERTIFICATION – INDIA
By means of Ministerial Resolutions No. 449, 465-2024/MINSA, Digemid officials were authorized to travel to India to carry out inspections to laboratories in India in order to grant the GMP certification.
