Life Sciences Newsletter – July 2021

IMPORTANT NEWS

CANNABIS

Artisanal production with associative cultivation of Medicinal Cannabis was authorized

By Law Nº 31312 published on July 25, 2021 in the Official Gazette El Peruano, the artisanal production with associative cultivation of medicinal cannabis was authorized.

The amendment includes the license of artisanal production with associative cultivation under the following premises:

• It consists of the production carried out by associations formed only by patients registered in the registry of users of cannabis and its derivatives for medicinal use.
• Associations may be made up of two or more patients registered in the aforementioned registry.
• The Ministry of the Interior must adopt the safety protocol to be applied in the artisanal production with associative cultivation to guarantee the physical intangibility of cannabis, as well as the finished product.
• The license shall be issued by the General Directorate of Medicines, Supplies and Drugs (Digemid).

Within a period of 60 calendar days that would expire on September 25, 2021, the draft regulations of this Law must be published.

Click aquí  to access Law Nº 31312.

TELEMEDICINE

SECURITY MECHANISMS FOR ELECTRONIC PRESCRIPTIONS WERE ESTABLISHED

Ministerial Resolution Nº 968-2021-MINSA established the security mechanisms for electronic prescription information in telemedicine services related to prescription and dispensing.

Click aquí to access the Administrative Directive adopted by RM Nº 968-2021-MINSA.

COSMETICS

The GMP regulation was adopted

Resolution Nº 2206 published on June 17, 2021 in the Official Gazette of the Cartagena Agreement, the Andean Technical Regulation of Good Manufacturing Practices in cosmetic products was adopted with the purpose of establishing the requirements of good manufacturing practices to be met by companies or establishments that manufacture, pack, condition or manufacture cosmetic products, which are marketed in the territories of the Member Countries of the Andean Community.

It shall enter into force thirty (30) months after the date of its publication in the Official Gazette of the Cartagena Agreement.

Click aquí  to access Resolution Nº 2206.

COVID

The Health Directive for the Epidemiological Surveillance of Covid-19 was updated

Ministerial Resolution Nº 881-2021/MINSA updated the Health Directive for the Epidemiological Surveillance of Covid-19 due to the change in the dynamics, virulence and epidemiological profile of new variants of the SARS-CoV-2 virus.

The main amendments are:

• The ratio of people with a higher risk of becoming seriously ill from COVID-19 was modified. Among them: Obesity of BMI 30 or more, down syndrome, pregnancy, HIV infection.
• The definition of post-vaccination infection, reinfection and genomic sequencing was included.
• The classification of reinfection by Covid-19 was included: suspected case, probable case and confirmed case of reinfection by Covid-19; as well as the notification and epidemiological surveillance of reinfections.
• The integration of genomic sequencing in Covid-19 surveillance was included to determine the incidence of variants of public health interest.
• Deadlines are set for the mandatory registration of molecular and antigenic test results.

Click aquí to access the Health Directive Nº 135-MINSA/CDC-2021 adopted by RM Nº 881-2021/MINSA.

The TECHNICAL DOCUMENT: ambulatory management of covid-19 was modified

Ministerial Resolution Nº 938-2021/MINSA modified the Technical Document: Outpatient management of people affected by Covid-19.

The main amendments are:

• It was determined that the risk factors identified are for becoming seriously ill from Covid-19.
• For suspected cases with illness time greater than seven days, a molecular test may be performed considering that its sensitivity decreases after day 10.

Click aquí to access the modifications of the Technical Document adopted d by RM Nº 938-2021/MINSA.

Medicinal Oxygen: Procedure for the National Registry of Producers and Traders

By Ministerial Resolution Nº 936-2021-SA the procedure for the National Registry of Producers and Traders.

It is mandatory for:

• Pharmaceutical establishments holding and not holding a health registration, health registration certificate or exceptional authorization that import, manufacture, package, fractionate, condition, recondition, store, distribute and commercialize medical oxygen.
• Non-pharmaceutical establishments (institutions or entities) that have exceptional authorization for the manufacture and use or import and use of medical oxygen.

Click aquí to access the Administrative Directive adopted by RM Nº 936-2021-SA.

FOOD

The Food and Nutritional Security Law was adopted

Law Nº 31315 published on July 26, 2021 in the Official Gazette El Peruano, the legal framework for the development of public policies on food and nutritional security was established, taking into consideration that the right to food is a fundamental right of people, recognized by the international agreements that Peru has signed.

Within 45 calendar days, this Law shall be regulated.

Click aquí to access Law Nº 31315.

Provisions for the elaboration of wines and wine by-products were established

Ministerial Resolution Nº 937-2021-MINSA established provisions related to the hygiene and safety conditions to be observed in the production of wines and their by-products.

Micro and small enterprises (MSEs) that produce alcoholic wine drinks and their derivatives must have the certification of General Principles of Hygiene of the Codex Alimentarius (PGH) issued by Digesa.

Click aquí to access to the Health Technical Standard adopted by RM Nº 937-2021-MINSA.

DIGESA: Communication on trans fats removal

Digesa reported that as of July 23, it is not allowed to manufacture, import and commercialize partially hydrogenated oils and fats, nor their use as an ingredient in the manufacture of industrialized food and beverages. In this sense, holders of health registrations must declare or modify the information already submitted, through TUPA 30 or 31 respectively, regarding the technological process used and that it is different from the partial hydrogenation that generates trans fats in the final product.

Click aquí to see Communiqué N°20-2021-DIGESA/MINSA.

HEALTH AUTHORIZATIONS

Vaccines: Provisions for registration and re-registration established

By Supreme Decree Nº 020-2021-SA published on July 25, 2021 in the Official Gazette El Peruano, the regulations that regulate the submission and content of the documents required for the registration and re-registration of biological products were adopted: vaccines.

It shall enter into force six months after the day following its publication.

Click aquí to access Supreme Decree Nº 020-2021-SA.

Conditional health registration: granted by manufacturers and countries

By Supreme Decree Nº 019-2021-SA, the Regulation for the Conditional Health Registration of Medicines and Biological Products adopted by Supreme Decree Nº 002-2021-SA was amended.

It was specified that the conditional health registration shall be granted by name, pharmaceutical form, amount of Active Pharmaceutical Ingredient – IFA, manufacturer(s) and country (countries).

Click aquí to access Supreme Decree Nº 019-2021-SA

Pesticides: Import procedure adopted for own consumption

Board Resolution Nº 0042-2021-MIDAGRI-SENASA-DIAIA adopted the procedure for Import, Surveillance and Control of Pesticides for Agricultural Use for Own Consumption (PRO-SIA-03) to carry out the surveillance and control of pesticides for agricultural use from their importation to their use in the field.

Click aquí to access Procedure PRO-SIA-03.

DIGEMID

Extension of qualifying certificates 

DIGEMID informed that the validity of the qualifying certificates that expire during August 2021 shall be extended for a period of one (01) year. It does not apply to those qualifying certificates that were already extended for a period of one (01) year under the First Transitory Complementary Provision of Legislative Decree Nº 1497, so their holders must timely request the renewal and/or re-registration of the same according to current regulations.

Click aquí to see Communiqué N°14-2021-DIGEMID.

OTHER REGULATIONS

Laboratories: New provisions on headquarters were established 

By Supreme Decree Nº 021-2021-SA, Article 94 of the Regulation of Pharmaceutical Establishments adopted by Supreme Decree Nº 014-2011-SA was amended.

This amendment was made to include the participation of professionals with knowledge, experience and training that accredit technical competence to assume the leadership of production, quality control and quality assurance in the laboratories of health products (cosmetics and personal and household hygiene products).

Click aquí to access Supreme Decree Nº 021-2021-SA.

PNUME: Citizen Participation

Ministerial Resolution Nº 925-2021-SA established provisions that allow the effective participation of citizens and institutions in general in the preparation of the Single National Petition for Essential Medicines (PNUME).

Click aquí to access the Technical Document adopted by RM Nº 925-2021-SA.

Health services: the national implementation plan for the RIS was adopted

Ministerial Resolution Nº 969-2021-SA adopted the National Plan for the Implementation of Integrated Health Networks (RIS) to contribute to improve the population’s access to health services through the progressive, planned, systematic and sustainable implementation of RIS at the national level.

Click aquí to access Ministerial Resolution Nº 969-2021-SA.