USE OF STICKERS FOR OCTAGONS
By means of Supreme Decree Nº 017-2023-SA, Articles 8.3 and 8.5 of the Manual of Advertising Warnings were modified within the framework of the provisions of Law Nº 30021, Law for the Promotion of Healthy Eating for Children and Adolescents.
This modification implies the use of stickers with the corresponding warnings, only for imported products, and micro and small companies, without prejudice to the possibility of printing them on the label in an indelible manner.
Adhesives must be of a permanent nature, difficult to remove, indelible, resistant to low or high temperatures depending on their use and of good adhesion for the type of surface used, and must not cover information.
ABSORBENT AND HOUSEHOLD HYGIENE PRODUCTS
By means of Resolution Nº 2335, the General Secretariat of the Andean Community modified Resolution Nº 1370 on Mandatory Health Notification (NSO) of household hygiene products and personal hygiene absorbent products.
The modification consisted of:
The Certificate of Free Sale is not required for obtaining and renewing the NSO, and its modifications.
The electronic NSO document can be submitted for recognition by member countries.
In products manufactured by subcontracting or maquila, the presentation of additional documents is allowed.
FOOD ADDITIVES – LIST
Through Communiqué Nº 01-2023-CODEX/PERU, DIGESA invited the public to make proposals to change or add information to the list of food additives of the International Codex Alimentarius (section 3 of Codex Standard CXG 36-1989).
Proposals can be submitted until August 15, 2023.
BIOLOGICAL PRODUCTS – FORMATS
Communiqué Nº 032-2023-DIGEMID informed about the modification of the formats of the communications of changes:
CERTIFICATION ON GOOD MANUFACTURING PRACTICES – FOREIGN MANUFACTURERS
On June 13, 2023 DIGEMID published the update of the Single List of manufacturing laboratories located abroad of pharmaceutical products pending Good Manufacturing Practices Certification.
Two issues are mentioned in this update:
Laboratories may submit to Customs, for the importation of products, the Certificate of Good Manufacturing Practices from the Competent Authority.
The list of laboratories that have not been certified in Good Manufacturing Practices is published.
HEALTH REGISTRATION – NOT REQUIRED
Digemid published on its website the list of products that are not subject to sanitary registration, updated as of April 21, 2023.
HOMOLOGATION OF “THREE FOLD DISPOSABLE SURGICAL MASK”
Ministerial Resolution Nº 520-2023-MINSA approved the Approval Form for “Disposable three-fold surgical mask”.
DISTRIBUTION AND TRANSPORT OF STRATEGIC HEALTH RESOURCES TO PUBLIC HEALTH SECTOR INSTITUTIONS
Ministerial Resolution Nº 534-2023-MINSA approved the Administrative Directive for the Process of Distribution and Transport of Strategic Health Resources to Public Institutions of the Health Sector.
The purpose of this Directive is to regulate the process of transporting Strategic Health Resources from the pharmaceutical warehouses to the public IPRESS, in order to maintain their correct state of conservation, their correct identification, and to comply with supply needs, determining the responsibilities involved.
The Directive regulates the details of the distribution modalities: from CENARES warehouses, through suppliers, with CENARES transport from UGIPRESS warehouses to IPRESS.
DRAFT REGULATION – CLINICAL TRIALS
By means of Ministerial Resolution Nº 559-2023-MINSA, the draft supreme decree that modifies and incorporates various articles in the Clinical Trials Regulation, approved by Supreme Decree Nº 021-2017-SA, was published.
The most important modifications and incorporations proposed through the draft are as follows:
Include new responsibilities of the sponsor: ensure that a CIEI, registered and accredited by the INS, approves all documents related to the clinical trial and authorizes its execution by the research institution; and ensure that minor changes in the protocol or consent format are in compliance with the regulations.
Differentiate between minor change from substantial change to the protocol and/or consent form. The first type of change requires authorization from an IRB/IEC. The second type of change, referred to as an amendment, requires authorization from the INS OGITT.
DRAFT REGULATION – LAW FOR THE PREVENTION OF CANCER IN WOMEN AND FOR THE STRENGTHENING OF SPECIALIZED ONCOLOGIC CARE
Ministerial Resolution Nº 538-2023-MINSA published the draft Regulations of Law Nº 31561, Law for the Prevention of Cancer in Women and the Strengthening of Specialized Oncology Care.
In general terms, the bill proposes:
The right to paid leave for workers who perform an early detection of breast and cervical cancer.
The duty of the public or private IPRESS to: make a referral of suspected cancer through the National Oncology Network; inform the patient of the results by e-mail, and if she authorizes it to her work center to facilitate continuity of care.
The duty of public or private IAFAS to include reconstructive surgical care for breast cancer patients in their plans.
