News

Procedures Enabled in VUCE

La DIGEMID, a través del comunicado publicado el 16 de setiembre de 2019 en su portal institucional, informa que, de acuerdo a lo dispuesto en el artículo 8° de la Resolución Ministerial N°668-2019-MINSA, a partir del 17 de setiembre del presente año se encuentran habilitados para su tramitación a través de plataforma virtual VUCE los procedimientos administrativos del 198 al 257, referidos a la Inscripción y Reinscripción en el Registro Sanitario de Productos Farmacéuticos y Dispositivos Médicos, y Certificados Oficiales de Importación y Exportación de Estupefacientes, Psicotrópicos y Precursores.​

Fuente: DIGEMID

Recent posts

Extension of the declaration of Sanitary Emergency

The MINSA included in the PNUME for the Health Sector, the product Medicinal Oxygen 93% gas for inhalation

MINSA ordered the publication of the Regulation Project that establishes specific provisions for conducting Clinical Trials with Medical Devices

The MINSA approved the Sanitary Directive for the use of Oxygen in Institutions Providers of Health Services and home use

MINSA approved the Technical Document: National Vaccination Plan against COVID-19

The MINSA orders the publication of the Technical Document project: Manual of Citizen Participation in the elaboration of the PNUME

MINSA approved the Technical Document: Management of people affected by COVID-19 in hospitalization services

MINSA approved the technical document: Guidelines for the exceptional health authorization of medical devices in the research stage

Urgent decree that dictates extraordinary measures to facilitate and guarantee the acquisition, conservation and distribution of vaccines against COVID-19

The MINSA plans to publish a draft ministerial resolution that resolves to include in the PNUME for the health sector, the medicinal oxygen product 93% gas

DIGEMID safety modifications: For pharmaceutical specialties containing "MELOXICAM"

The MINSA approves the update of the scale for infractions and sanctions to pharmaceutical and non-pharmaceutical establishments of the regulation of pharmaceutical establishments

DIGEMID safety modifications: For pharmaceutical products containing "Bacillus Clausii"

DIGEMID safety modifications: For pharmaceutical specialties containing "MONTELUKAST"

DIGEMID safety modifications: For pharmaceutical specialties containing "LORCASERIN"

DIGEMID safety modifications: For pharmaceutical specialties that contain "FENOTEROL"

The MINSA modified the Regulation of Narcotic Drugs, Psychotropic Drugs and Other Substances subject to Sanitary Inspection

The MINSA approved the "Technical Health Standard that establishes the ethical criteria for the promotion and advertising of pharmaceutical products, medical devices and health products"

Health Directive for the Control and Surveillance of in vitro Diagnostic Devices is approved: Rapid and Molecular Tests for COVID-19

The MINSA incorporated the file called: IVERMECTINA Oral Solution 6 mg/ml in the Technical Health Standard for the Manufacture of Pharmaceutical Preparations

MINSA incorporated Pharmaceutical Products to the List of Essential Goods for the management and treatment of COVID-19

MINSA published a Draft Regulation that Regulates Changes in the Sanitary Registry of Medical Devices

Administrative Directive that establishes the procedure for the provision of data to the Peruvian Observatory of Pharmaceutical Products of Essential Goods for the management of COVID-19

DIGEMID statement regarding the Virtual Attention of Communications of the information of Drugstores, Laboratories and Specialized Warehouses

DIGEMID statement regarding the exceptional authorization

They approve the "List of Galenic Products"

Provisions for the registration, re-registration and changes in the sanitary registry and the importation of pharmaceutical products and medical devices; and for the operation of pharmaceutical establishments

Extension of the suspension of the computation of processing periods of Administrative Procedures

The Health Directive for the control and surveillance of in vitro diagnostic devices is modified: Rapid and molecular tests for COVID-19

Modify the Technical Health Standard for the Preparation of Pharmaceutical Preparations

Approve the Technical Document: "Ethical Considerations for Health Research with Human Beings"

They approve the "List of Documents Considered Equivalent to the Certificate of Good Manufacturing Practices"

Extension of the suspension of the computation of processing periods of Administrative Procedures

The Ministry of Health of Peru approved the Sanitary Directive for the Control and Surveillance of In Vitro Diagnostic Devices: Rapid and Molecular Tests for COVID-19

The Transitory National Research Ethics Committee is formed for the evaluation and ethical supervision of Clinical Trials of the COVID-19 disease

They form the National Network for Health Technology Assessment (RENETSA) and approve other provisions

Temporary measures are issued to ensure the supply of products necessary for health during the Health Emergency declared as a consequence of COVID-19

They approve a document called: Technical Specification for the manufacture of textile face masks for community use

Law is published that regulates the use of modeling substances in body treatments for aesthetic purposes and defines said procedure as a medical act

Publican Ley que modifica el artículo 34° de la “Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios”

Exceptional authorization for the import and use of medicines, medical devices or health products with a medical prescription

DIGEMID ordered safety modifications in the pharmaceutical specialties that contain "QUINOLONES and FLUOROQUINOLONES"

They approve the regulation that establishes the classification rules and the essential principles of safety and performance of medical devices

Web application to report the discontinuation of the manufacture or import of medicines or biological products, and their reactivation

DIGEMID updates "List of products that to date are not subject to the granting of Sanitary Registration"

Publication of the Draft Technical Document: Manual of Good Pharmacovigilance Practices

DIGEMID statement on the mercury component in medical devices and cosmetic products

DIGEMID statement on the components Nonylphenol and Nonylphenol Ethoxylate

DIGEMID ordered safety modifications in the technical data sheet and/or in the insert of the medicines that contain "Ondansetron"

CAN approves resolution 2108: "Regulation of decision 833: Harmonization of legislation on cosmetic products"

Disponen la publicación del Proyecto de Decreto Supremo que modifica el Artículo 94 del Reglamento de Establecimientos Farmacéuticos

DIGEMID statement regarding the batch release of biological products: Vaccines or derivatives of human plasma

They provide for public opinion the Draft Regulations Regulating Changes of Major Importance of Pharmaceutical Products with Sanitary Registration

Control and surveillance actions in relation to the product Losartan

DIGEMID ordered security modifications in the technical data sheet and/or insert of the pharmaceutical specialties that contain "Diethylstilbestrol"

Control and surveillance actions in relation to the Ranitidine product

DIGEMID ordered safety modifications in the data sheet and/or insert of biological products containing "Ustekinumab"

List of foreign manufacturing laboratories of pharmaceutical products that are pending GMP certification by DIGEMID (period: 2010 to August 31, 2019)

Procedures Enabled in VUCE

They publish an annex to Ministerial Resolution No. 796-2019/MINSA "Technical Health Standard that regulates the preparation of the Risk Management Plan for Pharmaceutical Products"

Approve technical health standard that regulates the preparation of the risk management plan for pharmaceutical products

Approve the technical guide: inspection guide for good manufacturing practices for pharmaceutical products

IMPORT OF THE PRODUCT UNDER RESEARCH AND COMPLEMENTARY PRODUCTS

PROVISION OF THE REGULATION FOR THE SANITARY REGISTRATION OF SANITARY PRODUCTS: ARTICLES FOR BABIES AND ITS SUPREME DECREE APPROVING, TO THE PUBLIC OPINION

NEW TUPA FORMATS TO PROCESS IN PHYSICAL FORM AND PRESENTATION ON CD

STATEMENT ABOUT THE SANITARY REGISTRATION FOR SANITARY PRODUCTS: ITEMS FOR BABIES

STATEMENT ABOUT THE SIMPLIFICATION OF ADMINISTRATIVE PROCEDURES

THEY PROVIDE THE SIMPLIFICATION OF THE REQUIREMENTS OF TWENTY-SEVEN ADMINISTRATIVE PROCEDURES IN CHARGE OF THE DIGEMID

TECHNICAL DOCUMENT APPROVED: SINGLE NATIONAL REQUEST FOR ESSENTIAL MEDICAL DEVICES FOR THE HEALTH SECTOR

THE INCLUSION OF AUSTRIA AS A COUNTRY WITH HIGH SANITARY SURVEILLANCE IS APPROVED

LIST OF FOREIGN MANUFACTURING LABORATORIES OF PHARMACEUTICAL PRODUCTS THAT ARE PENDING BPM CERTIFICATION BY DIGEMID – Period: 2010 to June 30, 2019

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE TECHNICAL DATA SHEET AND/OR INSERT OF PHARMACEUTICAL SPECIALTIES CONTAINING "HORMONAL CONTRACEPTIVES"

INFORMATION ON REQUESTS FOR COMMUNICATIONS

MODIFY REGULATION OF PHARMACEUTICAL ESTABLISHMENTS

MODIFICATION OF THE CONCENTRATION AND PRESENTATION OF THE INJECTABLE TRASTUZUMAB 440 MG PRODUCT CONTEMPLATED IN THE SINGLE NATIONAL REQUEST FOR ESSENTIAL MEDICINES FOR THE HEALTH SECTOR

APPROVE NOTIFICATION FORMATS OF SUSPECTED ADVERSE INCIDENTS TO MEDICAL DEVICES BY THE HOLDERS OF SANITARY REGISTRY AND SANITARY REGISTRY CERTIFICATE, AND BY HEALTH PROFESSIONALS

THEY EXCLUDE VARIOUS PHARMACEUTICAL PRODUCTS FROM THE "LIST OF PHARMACEUTICAL PRODUCTS FOR CORPORATE PURCHASE FOR SUPPLY 2018-2019"

PUBLICATION OF THE LIST OF DIRECTORAL RESOLUTIONS ON THE IMPOSITION OF FINE ON THE WEB PAGE OF THE GENERAL DIRECTORATE OF MEDICINES, SUPPLIES AND DRUGS

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE TECHNICAL DATA SHEET AND IN THE INSERT OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "ATOMOXETINE"

LIST OF FOREIGN MANUFACTURING LABORATORIES OF PHARMACEUTICAL PRODUCTS THAT ARE PENDING BPM CERTIFICATION BY THE ANM

DIGEMID INFORMS THAT THE DATA OF THE RESPONSIBLE FOR PHARMACOVIGILANCE AND TECHNOVIGILANCE IN THE COUNTRY SHOULD BE COMMUNICATED

THEY APPROVE THE LIST OF REFERENCE PRODUCTS THAT WILL BE USED AS COMPARISONS IN THE CONDUCT OF THE THERAPEUTIC EQUIVALENCE STUDIES

PUBLISHED SCHEDULE-2019 FOR LABORATORIES AND DRUG STORES IN RELATION TO NARCOTIC DRUGS, PSYCHOTROPICS AND PRECURSORS PROCEDURES

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE TECHNICAL DATA SHEET AND IN THE INSERT OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "METAMIZOL"

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE TECHNICAL DATA SHEET AND IN THE INSERT OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "NOREPINEPHRINE"

LIST OF PRODUCTS THAT TO DATE ARE NOT SUBJECT TO GRANTING OF SANITARY REGISTRATION

MODIFY THE SINGLE TEXT OF ADMINISTRATIVE PROCEDURES OF THE MINISTRY OF HEALTH

LIST OF FOREIGN MANUFACTURING LABORATORIES OF PHARMACEUTICAL PRODUCTS THAT ARE PENDING BPM CERTIFICATION BY THE ANM PERIOD: 2010 to February 28, 2019

Dictate provisions referring to the requirement of the Certificate of Good Manufacturing Practices for the registration and re-registration in the Sanitary Registry and in the importation of pharmaceutical products

APPROVE "TECHNICAL HEALTH STANDARD THAT REGULATES THE MINIMUM INFORMATION THAT MUST BE CONTAINED IN THE VALIDATION DOCUMENT OF OWN ANALYTICAL TECHNIQUES"

FORM FOR THE EXCEPTIONAL AUTHORIZATION OF IMPORTS OF PHARMACEUTICAL PRODUCTS FOR INDIVIDUAL PREVENTION AND TREATMENT (ANNEX 1 AND ANNEX 2) – Version 2 –

APPROVE SUPREME DECREE Nº 005-2019-SA "REGULATION OF THE LAW THAT REGULATES THE MEDICINAL AND THERAPEUTIC USE OF CANNABIS AND ITS DERIVATIVES"

MODIFY ANNEXES OF VARIOUS RR.MM. REGARDING DIGEMID ADMINISTRATIVE PROCEDURES PROCESSED BY THE VUCE, IN ORDER TO UPDATE THE LIST OF SUCH PROCEDURES

APPROVED SINGLE ORDERED TEXT OF LAW Nº 27444 “GENERAL ADMINISTRATIVE PROCEDURE LAW”

ALERT FOR ANGIOTENSIN II RECEPTOR ANTAGONISTS (ARA II)

THEY APPROVE THE “BIOLOGICAL PRODUCT LOT RELEASE CERTIFICATE” FORMAT

DIGEMID ORDERED SECURITY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "NINTEDANIB"

THE TECHNICAL DOCUMENT IS APPROVED: UNIQUE NATIONAL REQUEST FOR ESSENTIAL MEDICINES FOR THE HEALTH SECTOR

FREE SALE CERTIFICATE (CLV) – COSMETIC PRODUCTS

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "CANAGLIFLOZIN, DAPAGLIFLOZIN AND EMPAGLIFLOZIN (SGLT-2 INHIBITORS)"