Life Sciences Newsletter – November 2024

LIFE SCIENCES NEWSLETTER

PHARMACEUTICAL ESTABLISHMENTS

DRAFT AMENDMENT TO THE REGULATION OF PHARMACEUTICAL ESTABLISHMENTS

Ministerial Resolution 797-2024/MINSA published the draft amendment to the regulation of pharmaceutical establishments approved by D.S. 014-2011-SA.

Some of the proposed changes are:

• Conditioning and reconditioning laboratories.

The requirement of having a quality control manager for this type of laboratories is eliminated.

• Certification of Good Practices (BP):

The BP certification is voluntary for pharmaceutical establishments that are not holders of a health registration or certificate of registration.

Good Pharmacovigilance and Pharmaceutical Office Practices certification is valid for an indefinite period of time.

• Closure due to security measures:

In case of temporary closure due to a security measure, whose holder does not request the lifting of the measure within the term the authority will arrange the definitive closure of the establishment.

The Ministry of Health will receive comments on the draft until Thursday, December 5, 2024.

GOOD PRACTICES

MANUAL OF GOOD PHARMACEUTICAL OFFICE PRACTICES

 Ministerial Resolution 810-2024/MINSA modified the Manual of Good Pharmacy Office Practices.

The most relevant changes to the Good Practices:

• Auxiliary areas and hygienic services may be shared, intended for changing uniforms and custody of personal items.
• Equipment used to maintain and measure the environmental conditions of products subject to cold chain can be qualified by the technical director of the pharmaceutical establishment or by third party service, taking into consideration at least the following points: installation, operation and performance qualification.
• Suspected serious adverse reactions must be reported in the official formats or eReporting or others (when applicable), within seven (07) calendar days of knowing the case, using the available means of communication.

GRANTING OF BPM CERTIFICATE

Ministerial Resolutions No. 762, 770, 781, 782, 783, 793, 805, 806, 808, 818 -2024/MINSA authorized Digemid officials to travel to laboratories in Argentina, Canada, China, Colombia, India and Mexico in order to obtain GMP certification.

COSMETICS

BILL ON ANIMAL TESTING

Bill 07688/2023-CR proposes to amend the “Animal Protection and Welfare Law, for the prohibition of animal testing for cosmetic purposes” – Law 30407.

This Bill establishes:

• The prohibition of testing or experimental use of any animal species in the cosmetic production process.
• The prohibition of the commercialization, distribution and importation of products that have used animals in any stage of testing or development.

The bill is pending to be submitted for debate and vote by the Plenary of the Congress of the Republic.

NATIONAL PETITION (PNUME)

COMPLEMENTARY LIST

Ministerial Resolution 792-2024/MINSA approved the complementary list to the PNUME for the treatment of tuberculosis.

DIGESA

ADMINISTRATIVE REORGANIZATION OF DIGESA

By Ministerial Resolution No. 809-2024/MINSA, the General Directorate of Environmental Health and Food Safety – DIGESA was declared under administrative reorganization in order to carry out a comprehensive evaluation of its processes and resources to ensure an effective and efficient operation and improve the quality of services.

Likewise, a Working Group has been created, whose functions will be the following:

1. To carry out a comprehensive evaluation of DIGESA’s processes and resources, focusing mainly on food safety issues related to food and beverages intended for human consumption.

2. To formulate recommendations on actions and measures for administrative and management reform for the reorganization of DIGESA, mainly in the area of food safety for food and beverages intended for human consumption.

3. To prepare and submit the final report to the head of the Ministry of Health detailing the results of the comprehensive evaluation and the proposed recommendations.

4. Others that may be necessary for the fulfillment of its purpose.

Within 90 calendar days, the Working Group shall submit the final report to the head of the Ministry of Health with the actions developed.

FOOD

ADHESIVE OCTAGONS

Peruvian Technical Standard 202.900:2024 was approved by Directorial Resolution N° 023-2024-INACAL/DN, which establishes the technical requirements for “difficult to remove adhesives” used to place “warning octagons” on food and beverage packages and containers.

This standard applies to products imported or manufactured by MYPES, in compliance with the Law for the Promotion of Healthy Eating for Children and Adolescents (Law No. 30021, amended by Law No. 31919).

For further information: Blog REM | Life Sciences Legal Product – November | Rodrigo Elias & Medrano.

DRAFT LAW ON FOOD LABELING AND ADVERTISING

Bill 08455/2023-CR proposes the modification of the Law for the Promotion of Healthy Eating for Children and Adolescents (Law 30021) and the Code of Consumer Protection and Defense (Law 29571).

This bill proposes to specify the general rules for food labeling and the rules for the advertising of juices, juices or nectars aimed at children under 16 years of age.

The proposals of the bill are:

• Juices or nectars aimed at children under 16 that do not meet Codex Alimentarius standards may not use images of fruit in their advertising.
• General and nutritional labeling of foods is mandatory. Nutritional claims must be substantiated in accordance with the relevant legislation or Codex Alimentarius.

NICOTINE

NEW REGULATION OF ELECTRONIC CIGARETTES AND TOBACCO

Law 32159, Law on the Control of Consumption of Tobacco Products, Nicotine or Substitutes of Both for the Protection of Life and Health (“the Law”), was published, which establishes new provisions for the commercialization, advertising, packaging and labeling of tobacco products, nicotine and other substitutes.

In general, rules for activities related to tobacco products are modified, and rules are established for the first time for activities with nicotine products (electronic cigarettes or vapes, and substances with nicotine).

For further information on the new law: Blog REM | Life Sciences Legal Product – November | Rodrigo Elias & Medrano.

HEALTH TECHNOLOGY ASSESSMENT

COST-EFFECTIVENESS ASSESSMENT OF HEALTH TECHNOLOGIES

Ministerial Resolution 820-2024-MINSA approved the Technical Document that establishes the standard methodology for the cost-effectiveness evaluation of health technologies.

This document is mandatory for the National Network for Health Technology Assessment (RENETSA) and is presented as a reference guide for other public and private institutions in the health sector that perform economic evaluations in this area.

VACCINATION

EXCEPTIONAL SANITARY AUTHORIZATION FOR TAKEDA VACCINE

The vaccine against dengue manufactured by the German laboratory Takeda GmbH obtained the exceptional authorization to be imported into Peru through the National Center for Strategic Health Resources Supply – CENARES.

The exceptional authorization was issued under Article 20 of Supreme Decree N° 016-2011-SA as amended, under the assumption of a public health situation that demonstrates the need and unavailability of the product in the country.

Directorial Resolution

DENGUE VACCINATION PILOT PLAN

Ministerial Resolution 807-2024/MINSA approved the Technical Document: Guidelines for vaccination against dengue during the implementation of the Pilot Plan 2024-2025. Likewise, the implementation of the Pilot Plan was authorized by Ministerial Resolution 764-2024/MINSA, designating the regions of Loreto, Piura, Tumbes and Ucayali as execution areas.

The established guidelines detail the organization, strategies and registration of dengue vaccination, targeting children and adolescents aged 10 to 16 years during the development of the pilot plan.