RARE AND ORPHAN DISEASES
Through a Communiqué dated June 20, 2024, the Ombudsman’s Office informed that the President of the Republic was requested to observe the autograph of the “Law that establishes measures to facilitate the access to medicines, biological products and medical devices registered in countries with high sanitary surveillance, destined to the treatment of rare or orphan diseases and low and high cost cancers”.
The ombudsman considers that the automatic approval of the sanitary registration with the sole presentation of the certificate accrediting the sanitary registration in a High Health Surveillance Country (PAVS) and the Certificate of Free Commercialization (CLV), would limit the functions of technical evaluation of the safety, efficacy and quality of the drugs that Digemid has, and would expose patients with treatment for rare and orphan diseases and cancers to potential risks to public health.
MEDICAL RECORDS – NEW CODES FOR DIAGNOSES
Ministerial Resolution No. 447-2024/MINSA expanded the use of the codes and descriptions of the International Statistical Classification of Diseases and Related Health Problems – ICD 10, previously established by Ministerial Resolution No. 553-2002-SA-DM. These codes are used for the recording of diagnosis in medical records.
The expansion is due to advances in medical knowledge and the implementation of new and diverse public health interventions at the national level, which has generated new needs in the field of community health.
These include new diagnoses such as fentanyl use 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 serious adverse reaction (Code Y4093), among others.
REGULATION OF HAZARDOUS SUBSTANCES
Last June, the Regulation and Control of Hazardous Substances for Domestic, Industrial and/or Public Health Use (Supreme Decree No. 031-2023-SA) entered into force.
By means of Ministerial Resolution No. 177-2024-MINCETUR, the procedure of “Sanitary Authorization for Chemical Products for Industrial Use”, established in Chapter III of Title II of the above mentioned regulation, was incorporated in the SWDS.
Likewise, through 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
Directorial Resolution No. 10-2024-INACAL/DN approved NTP-ISO 22003-1:2024 and NTP-ISO 22003-2:2024.
These technical standards specify the quality requirements for bodies that audit and certify food safety management systems or certify food products.
BPM CERTIFICATION – FOREIGN LABORATORIES
Ministerial Resolutions No. 402, 420, 421, 422, 423, 435 and 436-2024/MINSA authorized the travel of Digemid officials to carry out inspections to laboratories in Greece, Mexico, Colombia, Brazil, India and China in order to grant GMP certification.
