MINSA
HEALTH FACILITIES: CULTURAL IDENTIFICATION AND SIGNAGE
Ministerial Resolution Nº 527-2022/MINSA establishes that the identification and signage of health facilities at the first level of care with cultural relevance -which have indigenous, Amazonian, Andean and/or Afro-descendant populations within their scope- must have colors, pictograms and cultural characteristics particular to these populations.
PERU COMPRAS
PHARMACEUTICAL PRODUCTS: TECHNICAL DATA SHEETS
By Head Resolution Nº 000087-2022-PERÚ COMPRAS-JEFATURA, 133 technical data sheets of the item Medicines and pharmaceutical products of the List of Common Goods and Services were modified. The technical data sheets can be found at the following link: www.perucompras.gob.pe/lbsc.
MINSA
HEALTHY FOOD: DRAFT TECHNICAL PARAMETERS
Ministerial Resolution No. 526-2022/MINSA updates the technical parameters for the application of advertising warnings regarding the sugar, sodium and saturated fat content of processed foods. The draft proposes the modification of the Regulation of the Healthy Food Law. The bill mainly points out the following:
Comments shall be received during the 90 calendar day period through the following e-mail: webmaster@minsa.gob.pe.
CONGRESS
BILL: CONSTITUTIONAL REFORM OF THE RIGHT TO HEALTH CARE
Bill Nº 2551-2021-CR proposes that the State invest annually not less than 7% of the GDP in health. Likewise, it is proposed that the State must have the use of all medical-care resources of the public and private sectors in the context of a health emergency.
DIGEMID
INSPECTIONS FOR THE CERTIFICATION OF GOOD MANUFACTURING PRACTICES OF FOREIGN LABORATORIES
SUNAT
REMITTANCE ADVICES AND ELECTRONIC ISSUERS
By Superintendence Resolution Nº 000123-2022/SUNAT, several provisions on remittance advices are modified in order to adopt their electronic issuance as a general rule. The main modifications are the following: they incorporate new requirements to facilitate controls, establish the electronic documents that support the transfer of goods and designate the subjects that acquire the quality of electronic issuers of remittance advices. This regulation may be of interest to drugstores when issuing waybills for the commercialization and storage of pharmaceuticals, medical devices and health products.
DIGEMID/DIGESA
IMPORT AND EXPORT MEASURES AND FACILITIES FOR OAS
Supreme Decree Nº 013-2022-SA establishes import and export measures and facilities for companies certified as Authorized Economic Operators (AEO) for products regulated by DIGEMID and DIGESA.
DIGEMID
ADDITIONAL DEADLINES TO SUPPORT SAFETY AND EFFICACY
By Supreme Decree Nº 012-2022-SA additional deadlines are granted to support the safety and efficacy of pharmaceutical specialties included in Supreme Decree Nº 016-2013-SA. The new deadlines are:
| For cases of | Deadline | |
| 1 | Reformulation | Up to 6 months |
| 2 | Clinical studies | Up to 2 years |
MINSA
MANUAL OF GOOD PHARMACEUTICAL OFFICE PRACTICES
Ministerial Resolution Nº 554-2022/MINSA adopts the Technical Document: Manual of Good Pharmaceutical Office Practices, which establishes technical criteria and health conditions to be met by pharmacies, drugstores and pharmacies of health facilities. Thus, the Manual of Good Storage Practices for Pharmaceutical and Related Products, adopted by Ministerial Resolution Nº 585-99-SA/DM, and the Manual of Good Dispensing Practices, adopted by Ministerial Resolution Nº 013-2009/MINSA, are no longer in effect.
DIGEMID
NEW DIRECTOR GENERAL OF DIGEMID
Ministerial Resolution Nº 504-2022/MINSA appoints pharmaceutical chemist Lida Esther Hildebrandt Pinedo as the new Director General of Digemid.
DIGEMID
REGULATION REGULATING THE PURCHASE OF VACCINES AND MEDICINES AGAINST COVID-19
Supreme Decree Nº 014-2022-SA adopts the Regulation of Law 31225. The Regulation exceptionally authorizes regional governments, local governments or private companies to purchase the doses. Thus, it seeks to ensure the quality, safety and efficacy of vaccines and drugs against Covid-19 that have conditional health registration, imported or acquired by private companies, regional governments or local governments.
DIGESA
HEALTH STANDARD ON THE MANUFACTURE OF HIGH RISK HANDCRAFT PRODUCTS
Ministerial Resolution Nº 523-2022/MINSA publishes the draft Technical Health Standard “Health Standard for the implementation of the Integrated Production System in the elaboration of high risk artisanal dairy products”. Digemid shall receive comments until Wednesday, August 3, 2022 via email: webmaster@minsa.gob.pe.
DIGEMID
DOCUMENTS FOR REGISTRATION OF BIOLOGICAL PRODUCTS
Ministerial Resolution Nº 563-2022/MINSA publishes draft Regulation that regulates the presentation and content of the documents required for the registration and re-registration of biological products: Other biological products. The Regulation establishes the rules that regulate the presentation of such documents and the information that such documents must contain. Comments shall be received during a period of 90 calendar days via e-mail: webmaster@minsa.gob
