MINSA
RARE AND ORPHAN DISEASES
By a Communiqué of June 20, 2024, the Office of the Ombudsman reported that the President of the Republic was asked to observe the autograph of the «Law establishing measures to facilitate access to medicines, biological products and medical devices registered in countries of high health surveillance, for the treatment of rare or orphan diseases and low- and high-cost cancers».
The ombudsman considers that the automatic approval of the health record with the presentation of the certificate attesting to the health record in a Country of High Surveillance (PAVS) and the Free Marketing Certificate (CLV), would limit the functions of technical evaluation of the safety, efficacy and quality of medicines that has the Digemid, and would expose patients in treatment for rare and orphan diseases, and cancers to potential public health risks.
NEW CODES FOR DIAGNOSTICS
By Ministerial Resolution No. 447-2024/MINSA extended the use of codes and descriptions of the International Statistical Classification of Diseases and Health-related Problems – ICD 10 previously established by Ministerial Resolution No. 553-22002-SA-DM. These codes are used for recording the diagnosis in medical records.
The expansion is due to advances in medical knowledge and the implementation of new and diverse public health interventions at national level, The Community Health Service has been a key factor in the development of this new approach.
These include new diagnoses such as fentanyl consumption disorder, coronavirus disease (COVID-19), certain types of cancer and mental illness, as well as codes for mild/non-serious adverse reaction (Code Y4091), moderate/serious adverse reaction (Code Y4092) and severe adverse reaction (Code Y4093), among others.
DIGESA
DETAILS OF NEW DANGEROUS SUBSTANCES REGULATION
In June, the Regulation and Control of Dangerous Substances for Domestic, Industrial and/or Public Health Use (Supreme Decree No. 031-2023-SA) came into force.
By the Ministerial Resolution No. 177-2024-MINCETUR, the procedure of «Sanitary Authorization for industrial chemicals» was incorporated into the VUCE, as set out in Chapter III of Title II of the said Regulation.
Likewise, by means of Communiqué No. 14-2024-DIGESA/MINSA and Communiqué No. 15-2024-DIGESA/MINSA, Digesa made several clarifications regarding the application of the regulation.
FOOD – SAFETY CERTIFIERS
The NTP-ISO 22003-1:2024 and NTP-ISO 22003-2:2024 were approved by the Directorial Resolution No. 10-2024-INACAL/DN.
These technical standards specify quality requirements for bodies that audit and certify food safety management systems or perform The Commission’s proposal for a Council Directive on the certification of foodstuffs.
DIGEMID
BPM CERTIFICATION – FOREIGN LABORATORIES
Ministerial Resolutions Nos. 402, 420, 421, 422, 423, 435 and 436-2024/MINSA authorized the travel of Digemid officials to carry out inspections of laboratories in Greece, Mexico, Colombia, Brazil, India and China for the purpose of granting BPM certification.
