HEALTH DIRECTIVE FOR VACCINATION AGAINST COVID-19 IS MODIFIED
Ministerial Resolution Nº 1072-2022/MINSA amends Health Directive Nº 137-MINSA/DGIESP-2021, the Health Directive for vaccination against COVID-19, adopted by Ministerial Resolution Nº 1169-2021/MINSA.
The referred Sanitary Directive incorporates Annex Nº 1-F entitled Characteristics of the RNA Messenger RNA vaccine (Comirnaty) Original/Omicron BA.4-5 Injectable Dispersion.
https://www.gob.pe/institucion/minsa/normas-legales/3782483-1072-2022-minsa
PROTOCOL FOR THE APPLICATION OF THE BIVALENT BOOSTER DOSE OF THE COVID-19 VACCINE
On December 29, 2022, the protocol for the application of the bivalent booster dose for the year 2023 against COVID-19 was published on the official website of the Ministry of Health. It is established that the application shall be carried out in the IPRESS of the Minsa, the Armed Forces, the National Police and private entities of the health sector.
The application of the bivalent booster dose, as part of the vaccination scheme, shall be carried out according to the availability of the vaccine and the schedule established by the ministry.
https://cdn.www.gob.pe/uploads/document/file/4008352/Protocolo%20para%20la%20aplicaci%C3%B3n%20de%20la%20dosis%20de%20refuerzo%20bivalente%20para%20el%20a%C3%B1o%202023%20en%20la%20vacunaci%C3%B3n%20contra%20la%20COVID-19.pdf?v=1672371208
ANDEAN TECHNICAL REGULATION FOR THE LABELING OF COSMETIC PRODUCTS
Resolution Nº 2310 adopted the Andean Technical Regulations for the Labeling of Cosmetic Products applicable in CAN Member Countries. The main provisions are detailed below:
The use of supplementary labeling is allowed to present or clarify labeling information, except for including the lot number.
Changes in the label that do not imply modification in the information of the notified labeling (colors, drawings or others) shall not require to be informed to Digemid.
Digemid shall allow the marketing of cosmetics whose labels contain additional information to that required by the regulation, provided they do not contravene it.
Digemid may waive the requirement of printing the NSO code and trademark on the label.
Cosmetic products must have stability studies, which must be available to the authority for control and surveillance purposes.
It is mandatory to declare the expiration date on the label when the shelf life is less than or equal to 2 years.
The aforementioned regulation shall enter into force on December 16, 2024.
https://www.comunidadandina.org/DocOficialesFiles/Gacetas/GACETA%205095.pdf
MODIFICATION OF DECISION 706 ON DOMESTIC HYGIENE PRODUCTS AND ABSORBENT PERSONAL HYGIENE PRODUCTS
On December 29, 2022, Decision 908 was published, which modified Articles 7 and 11 of Decision 706 “Harmonization of legislation on domestic hygiene products and absorbent personal hygiene products”. The changes are detailed below:
The requirement to present the Certificate of Free Sale or similar authorization is eliminated, as well as consularized declaration of the responsible person in the country of origin, for products manufactured outside the Andean sub-region.(Article 7).
In the NSO recognition procedure (homologation) the certified copy or electronic document of the NSO may be submitted (Article 11).
https://www.comunidadandina.org/DocOficialesFiles/Gacetas/GACETA%205097.pdf
LIST OF PROHIBITED AND RESTRICTED SUBSTANCES FOR BABY ARTICLES
The regulation adopted by Supreme Decree Nº 010-2022-SA establishes that baby items (bottles, pacifiers, teethers, among others) must be safe and not contain prohibited or restricted substances that represent a risk or danger to the baby’s health. Along these lines, through Directorial Resolution Nº 159-2022-DIGEMID-DG-MINSA, on December 29, 2022, the list of prohibited or restricted substances for the aforementioned articles was published. The list contains the following: a) N-nitrosamines and N-nitrosatables; b) Chemical elements (antimony, arsenic, barium, cadmium, lead, chromium, mercury and selenium); c) PVC-derived phthalates.
DIGESA
MARKETING OF TOYS CONTAINING BIS(2-ETHYLHEXYL) PHTHALATE (DEPH) AT LEVELS EXCEEDING THE PERMITTED LIMITS
Through Communiqué N° 26-2022-DIGESA/MINSA, it was informed that in view of the consumer alert on the commercialization of toys called Cry Babys, which contain bis (2-ethylhexyl) phthalate (DEPH), at levels exceeding the permitted limits, Digesa has been carrying out the following actions:
