EXTENSION OF SHELF LIFE OF COVID-19 VACCINES
By means of Communiqués N°001-2024 and N°003-2024, Digemid informed that the lots available at national level of the following vaccines have the respective authorizations for shelf life extensions:
NEW DIRECTIVE ON COVID-19 AT WORK
Ministerial Resolution No. 022-2024/MINSA approved Administrative Directive No. 349-MINSA/DGIESP-2024, “Administrative Directive that establishes the provisions for the surveillance, prevention and control of the health of workers at risk of exposure to SARS-CoV-2”.
The new Directive establishes rules and recommendations for dealing with surveillance, prevention and control of Covid-19 in the workplace. It regulates matters such as ventilation in the establishment, reinstatement of workers, protocol for suspected cases, hand washing or disinfection points, sensitization for the prevention of contagion, and other preventive measures.
Likewise, through Press Release No. 002-2024, Minsa assured that this Directive does not eliminate the medical rest for Covid-19, but that it will be up to the treating physician to determine the need and duration of the rest.
MODIFICATION OF THE TECHNICAL STANDARD ON COVID-19 VACCINATION
By Ministerial Resolution No. 033-2024-MINSA, the “Technical Health Standard establishing vaccination against COVID-19”, approved by Resolution No. 863-2023/MINSA, was modified.
The most relevant modifications:
LAW – HEALTH CARE-ASSOCIATED INFECTIONS (IAAS)
Law No. 31972 was published, which provides for the strengthening of the prevention and control of health care associated infections (HAI).
The provisions contained in the law are mandatorily applied in all health care provider institutions (IPRESS) of the Ministry of Health, regional governments, local governments, the Social Health Insurance (ESSALUD), the Armed Forces, the Peruvian National Police, the private sector and other health care providers throughout the country.
All IPRESS will have to implement measures that will be developed in a Regulation.
For its part, Minsa will annually supervise the epidemiological surveillance of HCAIs in IPRESS -whether public, private or mixed-. Likewise, an accreditation process in HCAI prevention and control will be implemented within one year, which will be mandatory for all IPRESS.
BREAST CANCER
By means of Supreme Decree No. 001-2024-SA, the Regulation of Law No. 31561, “Law for the Prevention of Cancer in Women and the Strengthening of Specialized Oncological Care” was published. The Regulation contains the following provisions:DIABETES MELLITUS TYPE 1: NATIONAL PETITORY (PNUME)By Ministerial Resolution No. 049-2024/MINSA, two drugs for the treatment of Diabetes Mellitus Type 1 were added to the Health Sector’s Single National Formulary of Essential Medicines (PNUME):
MODIFICATION TO THE CHILEAN COSMETICS REGULATION
Chile notified the Committee on Technical Barriers to Trade of the World Trade Organization of its Draft Amendment to the Regulations of the National Cosmetics Control System. The deadline for interested parties to submit comments on this Draft Amendment is February 18, 2024.
From a general review, the most relevant modifications can be noted:
1. Opening to e-labelling: Incorporation of requirements through electronic labeling or e-labelling.
2. Labeling of small packages: incorporation of a section for labeling small package products.
3. Bulk: incorporates the possibility of using the “fractionation” modality for cosmetic products.
4. Traces and prohibited substances: clarifies the acceptance of prohibited substances when they are technically unavoidable, adopting the provisions of European Regulation 1223.
5. Some requirements (of an environmental nature) are established with respect to the packaging of products under the fractionation scheme.
6. A chapter on Cosmetovigilance is incorporated, establishing obligations for companies on issues such as notification of adverse effects, among others.
7. New Labeling and Good Manufacturing Practices requirements.
