Ministerial Resolution 797-2024/MINSA published the draft amendment to the regulation of pharmaceutical establishments approved by D.S. 014-2011-SA.
Ministerial Resolution 797-2024/MINSA published the draft amendment to the regulation of pharmaceutical establishments approved by D.S. 014-2011-SA.
Ministerial Resolution 797-2024/MINSA published the draft amendment to the regulation of pharmaceutical establishments approved by D.S. 014-2011-SA.
Ministerial Resolution 797-2024/MINSA published the draft amendment to the regulation of pharmaceutical establishments approved by D.S. 014-2011-SA.
Modification to the regulation of the Cancer Law includes changes in 8 articles and includes a final complementary provision.
Modification to the regulation of the Cancer Law includes changes in 8 articles and includes a final complementary provision.
Ministerial Resolution 797-2024/MINSA published the draft amendment to the regulation of pharmaceutical establishments approved by D.S. 014-2011-SA.
Modification to the regulation of the Cancer Law includes changes in 8 articles and includes a final complementary provision.
Modification to the regulation of the Cancer Law includes changes in 8 articles and includes a final complementary provision.
Ministerial Resolution 797-2024/MINSA published the draft amendment to the regulation of pharmaceutical establishments approved by D.S. 014-2011-SA.
Modification to the regulation of the Cancer Law includes changes in 8 articles and includes a final complementary provision.
Regulations on pharmaceutical establishments and health registrations under Law No. 32033.
The Digemid informed that, through the virtual desk, applications for registration or re-registration of health registrations for the treatment of rare or orphan diseases that have been registered in any of the countries with high health surveillance.
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”.
Regulatory developments related to the regulation of veterinary products and animal feed.
Law on Pharmaceutical Products and Medical Devices that guarantees and promotes access and use of generic drugs in International Nonproprietary Names (INN) and strengthens the regulation of pharmaceutical products and medical devices for the benefit of patients and users.
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".
Law No. 32033, which guarantees and promotes access to and use of generic medicines in the International Nonproprietary Name (DCI), was published in the Diario Oficial El Peruano and strengthens the regulation of pharmaceuticals and medical devices for the benefit of patients and users.
By Ministerial Resolution No. 314-2024/MINSA, the draft Regulation of Law No. 31881 was published, "Law that promotes providing information on foods that do not contain gluten" (hereinafter referred to as the Draft Regulation).
Ministerial Resolution No. 220-2024/MINSA published the list of generic essential medicines in International Nonproprietary Name to be offered by private pharmacies and drugstores, under the provisions of Emergency Decree No. 005-2024.
Emergency Decree No. 005-2024 was published, which dictates extraordinary measures to guarantee access to generic medicines to the population.
By means of Ministerial Resolution No. 098-2024/MINSA, the deadline established in paragraph b) of Article 1 of Ministerial Resolution No. 195-2022/MINSA, referring to the submission of the bioequivalence study report for drugs that require bioequivalence studies (in vivo), was extended for twenty-four (24) months, counted as of its expiration.
On November 8, 2023, Law N° 31919 was published, which modified Article 10 of the Law for the Promotion of Healthy Eating for Children and Adolescents (Law N° 30021).
By means of Communiqués N°001-2024 and N°003-2024, Digemid informed that the lots available at national level of the following vaccines have some authorizations for shelf life extensions.
On December 2, 2023, Supreme Decree No. 031-2023-SA was published in the Official Gazette El Peruano approving the "Regulation and Control of Hazardous Substances for Domestic, Industrial and/or Public Health Use" (hereinafter "the Regulation").
Through Supreme Decree No. 031-2023-SA, the new "Regulation and Control Regulation of Hazardous Substances for Domestic, Industrial and/or Public Health Use" was published.
Supreme Decree No. 33-2023-SA extends the deadlines to obtain categorization or recategorization, as well as the approval of the Activity Plan of the IPRESS before the Health Directorates.
Modification of the Law for the Promotion of Healthy Eating for Children and Adolescents (Law N° 30021)
Several articles were modified and incorporated into the Regulation of Clinical Trials, approved by Supreme Decree No. 021-2017-SA.
On September 27, 2023, Law N° 31881 (hereinafter, the Law) was published, which aims to provide information on foods that do not contain gluten on product labels so that consumers, mainly people suffering from celiac disease, intolerance or joy to gluten, can make informed consumption decisions.
Ministerial Resolution Nº 633-2023/MINSA approved the new Single National List of Essential Medicines (PNUME) for the Health Sector and repealed the previous one, approved by Ministerial Resolution Nº. 1361-2018/MINSA.
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.
Food and Beverages of foreign origin and imported into the country shall not include the Advertising Warnings (Octagons) indelibly on the labels: The use of stickers is authorized indefinitely.
COVID-19 is no longer considered an international health emergency, according to the announcement of the World Health Organization (WHO).
COVID-19 is no longer considered an international health emergency, according to the announcement of the World Health Organization (WHO).
DIGESA communicated through its website details on the application for health registration of foodstuffs.
Supreme Decree No. 003-2023-SA extended the national health emergency due to the existence of COVID-19 for a period of ninety (90) calendar days as of February 25, 2023.
Processed foods and non-alcoholic beverages that exceed the technical parameters established in the Regulation, specified through the Advertising Warnings Manual, must include Advertising Warnings (Octagons) on the front side of the label of the products.
Ministerial Resolution Nº 1072-2022/MINSA amends Health Directive Nº 137-MINSA/DGIESP-2021, the Health Directive for vaccination against COVID-19
Ministerial Resolution Nº 945-2022/MINSA adopted the Complementary List of Medicines for the Treatment of Neoplastic Diseases to the Single National List of Essential Medicines for the Health Sector.
Ministerial Resolution Nº 863-2022/MINSA publishes the draft Technical Document: Single National Request for Essential Medicines for the Health Sector on the website https://participacionciudadanapnume.minsa.gob.pe for a period of 60 calendar days in order to receive the opinions of citizens and institutions.
Ministerial Resolution Nº 735-2022/MINSA publishes the draft "List of Abbreviated Designations of Pharmaceutical Products and their classification for Standard Health Data Identification Nº 002".
Supreme Decree Nº 108-2022-PCM extended the State of National Emergency until September 30, 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.
It is provided that the Electronic Health Record Information Systems whose ownership is exercised by the MINSA shall be called Electronic Health Record Information Systems - SIHCE of the MINSA.
Through Supreme Decree Nº 156-2021-PCM the government clarified that passengers entering Peru must have a molecular test with a result date no more than 72 hours before boarding from their point of origin. It is not mandatory to present a vaccination card or certificate.
The Ministry of Health officially launched the National Registry of Medicinal Oxygen - Renoxi Peru, which allows to know the stock and consumption of medicinal oxygen reported by public, private or mixed Health Service Provider Institutions (IPRESS) throughout the country. Renoxi Peru was created in compliance with Law Nº 31113 that regulates, authorizes, ensures and guarantees the use of medicinal oxygen in health facilities.
The Ministry of Health (Minsa) adopted Health Directive Nº 134-MINSA/2021-INS (Ministerial Resolution Nº 804-2021-MINSA) that establishes specific provisions for the use and application of rapid tests for the detection of SARS-CoV-2 virus antigens.
The Ministry of Health (Minsa) adopted Health Directive Nº 134-MINSA/2021-INS (Ministerial Resolution Nº 804-2021-MINSA) that establishes specific provisions for the use and application of rapid tests for the detection of SARS-CoV-2 virus antigens.
Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry.
Health Emergency: By Supreme Decree No. 009-2021-SA the State of Health Emergency was extended until September 2, 2021.
Personal data processing related to health - National Registry of Vaccination against COVID-19.
Supreme Decree No. 002-2021-SA adopted the regulation for granting conditional health record of the COVID-19 vaccine with phase III clinical trials with preliminary results. The General Directorate of Medicines, Supplies and Drugs (Digemid) has a maximum period of 3 months to grant the aforementioned record. The conditional health record is valid for one year and may be renewed 4 times.
Telehealth and Personal Data in Peru.
Seroprevalence: The National Center of Epidemiology, Prevention and Disease Control published on its website the progress of the seroprevalence study for COVID-19 in Peru.
The Directive establishing the processing of personal data related to health or personal data in health is adopted.
Through Supreme Decree No. 027-2020, the State of Health Emergency was extended until December 7.
Criteria are established for the promotion and advertising of pharmaceutical products, medical devices and sanitary products.
The entity has issued various communiqués to users during the last week regarding the following...
Legislative Decree 1490: provisions to strengthen telehealth services are established
The Andean Community published the Draft Andean Technical Regulation on the Labelling of Cosmetic Products which provides that any member country of the CAN may dispense with the requirement of NSO printing on the label in compliance with commitments assumed in trade agreements between countries.
DIGEMID: List of generic drugs that must be kept available in pharmacies and drugstores
GENERAL MEDICINE, INPUT AND DRUG ADMINISTRATION (DIGEMID)
Implementation Plan Of The National Registry Of Electronic Medical Records (Renhice)
Executive Branch sent the bill “Act declaring drugs, biological products and medical devices as essential part of right to health and provides measures to guarantee their availability” to the Congress for review
By virtue of Supreme Executive Order No. 016-2019-SA dated June 29, the Ministry of Health and the Ministry of Economy and Finance caused to amend the ...
Amendments to octagonal-shaped warning labels pursuant to healthy food act: exceptions and adhesive using term...
Peru does not have a specific regulation for e-cigarettes. In addition, provisions regulating the use of tobacco (Act No. 28705 “General Act for the Prevention and Control of Tobacco Consumption Risks” and its Regulations approved by Supreme Executive Order No. 015-2008-SA) are not applicable for this type of product. Therefore, they do not satisfy the definition of “Tobacco Products” set forth in the Regulations.
By virtue of Director’s Resolution No. 366-2019/MINSA published in the Peruvian Gazette “El Peruano”, the reference product list that will be used as a comparator in therapeutic equivalence study was approved.
Our attorneys, María Del Carmen Alvarado and Ricardo De Vettor, have contributed with the preparation of the chapter referred to the current Life Science legislation in Peru, in the seventh edition of The Life Sciences Law Review.
Filing label in the food sanitary registry in the General Environmental Health Agency (DIGESA) is eliminated.
Technical standard for health regulating minimum data for in-house analytical techniques validation. The Ministerial Order No. 234-2019/MINSA was published in the Official Gazette “El Peruano”. This Ministerial Order approved the Technical Regulation for Health (NTS) No. 147-MINSA/2019/DIGEMID that regulates minimum data to be included in the document for in-house analytical techniques validation.
«Rodrigo, Elías & Medrano Abogados is a good strategic partner that finds solutions to regulatory issues in a timely and creative manner.» – Chambers & Partners Latin America, 2025: Life Sciences Our Life Sciences & Healthcare group is comprised by lawyers and pharmacists. The team regularly advises pharmaceuticals (pharmaceutical products, cosmetics and healthcare products), […]
Legality of medical cannabis in Peru arose in October 2017 pursuant to Act No. 30681, regulating medical and therapeutic cannabis and byproducts. Pursuant this Law, a regulated research, import, trade and production system for cannabis and byproducts for medical and therapeutic purpose only was established.
PRACTICES Life Sciences Paul Miyashiro is a pharmaceutical chemist. He specializes in health regulation and practices this discipline without providing legal advice. He advises on health regulation of pharmaceuticals, medical devices and health products (cosmetics, personal and household hygiene products), pesticides for domestic use and public health. Paul also participates in the implementation and quality […]
PRACTICES Life Sciences Intellectual Property Solange Noriega Zumaeta specializes in pharmaceutical law and health regulation, as well as industrial property matters. She is experienced in issues related to health regulations of pharmaceutical products, health products (cosmetics, personal and household hygiene products), pesticides for domestic use and public health, medical devices, natural products, cannabis, food and […]
PRACTICES Life Sciences & Healthcare Cecilia Alarcón is a pharmaceutical chemist. She specializes in health regulation and practices this discipline without providing legal advice. With more than 10 years of experience, she advises on health regulation of pharmaceuticals, medical devices and medical products (cosmetics, personal and household hygiene products, disinfectants), pesticides for domestic use and public […]
PRACTICES Life Sciences Intellectual Property Maritza Reátegui heads our Life Sciences practice area. She advises companies in the pharmaceutical and biotechnology industries, health products (cosmetics, personal and household hygiene products), pesticides for domestic and public health use, medical devices, natural products, cannabis, food and beverages. Maritza is director of the master’s degree in Intellectual Property […]
PRACTICES Intellectual Property Unfair Competition Consumer Protection Life Sciences María del Carmen Alvarado leads our Intellectual Property and Consumer Protection area. She specializes in intellectual property with emphasis on trademarks, patents, copyright, and domain names, as well as on life sciences & healthcare, unfair competition and consumer protection. She has been head of the Office of […]
PRACTICES Intellectual Property Life Sciences & Healthcare Ricardo De Vettor specializes in trademarks, copyright, consumer protection, unfair competition, violation processes and life sciences & healthcare. He counsels on issues of industrial property, copyright, unfair competition, consumer protection, pharmaceutical products and clinical trials. Ricardo counsels on designing litigation strategies, and represents clients in all kinds of […]
PRACTICES Life Sciences Intellectual Property Daniela Supo specializes in trademarks, copyrights, patents, unfair competition, consumer protection and life sciences. She comprehensively advises domestic and foreign companies on industrial property, copyright, unfair competition, consumer protection, pharmaceutical products and clinical trials matters. Daniela also counsels on the design of litigation strategies and sponsors clients in all types […]
