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Life Sciences Newsletter – June 2021

IMPORTANT NEWS

COVID

Rapid tests for COVID-19 antigen detection

The Ministry of Health (Minsa) adopted Health Directive Nº 134-MINSA/2021-INS (Ministerial Resolution Nº 804-2021-MINSA) that establishes specific provisions for the use and application of rapid tests for the detection of SARS-CoV-2 virus antigens.

The directive sets out the technical conditions to be met by health personnel, test storage conditions, procedures for sample collection, processing and interpretation of results, required areas, among other provisions to be met by the places where such tests are performed.

Click aquí  to access the resolution.

Guidelines for the entry and exit of travelers to Peru

New provisions for entry and exit by air, river and land transportation to and from Peru were adopted by Ministerial Resolution Nº 780-2021-MINSA.

Regarding air transportation, travelers entering the country must fill out an affidavit online at https://e-notificacion.migraciones.gob.pe/dj-salud/, have a negative RT-PCR molecular test and wear a double mask.

At the time of landing at the Peruvian airport, travelers may be subject to random sampling.

To leave Peru, they must only wear a double mask and not have symptoms compatible with COVID-19.

Click aquí to access the resolution.

HEALTHY AND EATING

Use of stickers on octagons

Supreme Decree Nº 018-2021-SA adopted the extension of the deadline for the use of stickers until March 31, 2022. This extension shall allow products to use stickers on the labeling to place the advertising warnings HIGH IN SODIUM, HIGH IN SATURATED FATS, HIGH IN SUGAR.

Click aquí to access the supreme decree.

DIGESA

Draft amendments to food registration regulations

Supreme Decree Nº 784-2021-SA adopted the publication of the draft amendment to the regulation on surveillance and health control of food and beverages (D.S. 007-98-SA).

The draft amendment includes changes in the certification of the Official Technical Validation of the HACCP Plan and of the General Principles of Hygiene of the Codex Alimentarius (PGH); it also specifies requirements for registration and re-registration in the health registry of food and beverages and details the types of changes and modifications subject to registration before Digesa. Additionally, it incorporates changes in the import health registration certificate procedure, health registration of fractioned food, authorization of additives, among others.

Suggestions, comments or recommendations may be sent until September 25, 2021, by e-mail to webmaster@minsa.gob.pe.

 Click aquí to access the resolution.

COSMETICS

On June 17, 21021 the Andean Technical Regulation on Good Manufacturing Practices (GMP) for cosmetic products was published by Resolution Nº 2206 of the General Secretariat of the Andean Community.

The Regulation shall enter into force on December 17, 2023 (30 months after the date of its publication), as established in the only final provision of the resolution.

A harmonized GMP checklist and evaluation criteria shall be adopted within 6 months of its publication, with the favorable opinion of governmental experts.