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COMMUNICATIONS FORMAT IN THE SANITARY REGISTRY OF PHARMACEUTICAL PRODUCTS – Version 02

La Dirección de Inspección y Certificación de la DIGEMID a través del comunicado publicado el 16 de noviembre en su Portal Institucional, hace de conocimiento que ha publicado una nueva versión del “FORMATO DE COMUNICACIONES EN EL REGISTRO SANITARIO DE PRODUCTOS FARMACÉUTICOS-Versión 02”, este nuevo documento contempla nuevos procedimientos que no requieren pronunciamiento de la DIGEMID. Por lo tanto, la DIGEMID solo tomará conocimiento de lo comunicado por cada empresa a través de este formato.
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La nueva versión del “FORMATO DE COMUNICACIONES EN EL REGISTRO SANITARIO DE PRODUCTOS FARMACÉUTICOS-Versión 02” entrará en vigencia el 19 de noviembre del 2018.
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Source: DIGEMID

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DIGEMID updates the list of products that to date are not subject to the granting of sanitary registration

Draft technical document published: manual of good pharmacovigilance practices

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

DIGEMID statement on nonylphenol and ethoxylated nonylphenol components

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"

They provide for the publication of the draft supreme decree that modifies article 94 of the regulation of pharmaceutical establishments

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

They provide for the public opinion the draft regulation that regulates the major changes 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)"

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF THE PHARMACEUTICAL SPECIALTIES THAT CONTAIN "TRAMADOL"

DIGEMID ORDERED SECURITY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET AND MEDIATE AND IMMEDIATE LABELING OF PHARMACEUTICAL SPECIALTIES CONTAINING "HYDROXYETHYL STARCH"

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

TECHNICAL DOCUMENT "NATIONAL LIST OF VITAL PHARMACEUTICAL PRODUCTS" APPROVED

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF GADOLINIUM-BASED CONTRAST MEDIA

COMMUNICATIONS FORMAT IN THE SANITARY REGISTRY OF PHARMACEUTICAL PRODUCTS – Version 02

APPROVED LIST OF PHARMACEUTICAL PRODUCTS FOR SECTOR CORPORATE PURCHASE OF PHARMACEUTICAL PRODUCTS, SUPPLY 2019 - 2020 AND THE LIST OF PARTICIPATING ENTITIES

LIST OF FOREIGN MANUFACTURING LABORATORIES OF PHARMACEUTICAL PRODUCTS THAT ARE PENDING CERTIFICATION IN BPM BY THE ANM Period: 2010 to October 15, 2018

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "ULIPRISTAL ACETATE 5mg"

THE SUPREME DECREE IS PUBLISHED THAT "APPROVES THE REGULATION THAT REGULATES THE INTERCHANGEABILITY OF MEDICINES"

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

ALERT REGARDING DRUGS CONTAINING LEVOTHYROXINE, LIOTHYRONINE OR THE ASSOCIATION OF BOTH

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

THE SUPREME DECREE IS PUBLISHED THAT "AMENDS THE REGULATION FOR THE REGISTRATION, CONTROL AND SANITARY SURVEILLANCE OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND SANITARY PRODUCTS" AND "APPROVES THE MANUAL OF GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS"

LIST OF FOREIGN MANUFACTURING LABORATORIES OF PHARMACEUTICAL PRODUCTS THAT ARE PENDING BPM CERTIFICATION BY THE ANM (AUGUST -2018)

INCONSISTENT LEVELS OF THE ACTIVE SUBSTANCES LEVOTHYROXINE AND LIOTHYRONINE OR ASSOCIATION OF THEM

VARIOUS PHARMACEUTICAL PRODUCTS EXCLUDE FROM THE LISTS APPROVED THROUGH RM Nº 528-2016/MINSA

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT, TECHNICAL DATA SHEET AND/OR MEDIATE LABELING OF MEDICINES CONTAINING "VALPROATE"

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

THEY APPROVE THE MANUAL OF GOOD LABORATORY PRACTICES FOR THE QUALITY CONTROL OF PHARMACEUTICAL PRODUCTS

APPROVE REGULATION GOVERNING THE ISSUANCE OF THE LOT RELEASE CERTIFICATE OF BIOLOGICAL PRODUCTS: VACCINES OR HUMAN PLASMA DERIVATIVES

THE PROJECT OF "TECHNICAL HEALTH STANDARD THAT REGULATES THE PREPARATION OF THE RISK MANAGEMENT PLAN OF PHARMACEUTICAL PRODUCTS" IS AVAILABLE TO THE PUBLIC OPINION

PERUVIAN TECHNICAL STANDARDS VERSION 2018 APPROVED ON CONCRETE, CONCRETE, AGGREGATES AND CEMENTS

WITHDRAWAL FROM THE MARKET OF SOME BATCHES OF MEDICINES CONTAINING VALSARTAN

ACTIVE PRINCIPLE VALSARTAN OBSERVED BY THE EUROPEAN MEDICINES AGENCY AND THE SPANISH AGENCY OF MEDICINES AND HEALTH PRODUCTS

APPROVE PERUVIAN TECHNICAL STANDARDS RELATING TO MEAT AND MEAT PRODUCTS, ALCOHOLIC BEVERAGES, AUTOMOTIVES, STARCHES, BIOTECHNOLOGY AND OTHERS

N-NITROSODIMETHYLAMINE (NDMA) CONTAMINATION OF VALSARTAN, CLASSIFIED AS A PROBABLE HUMAN CARCINOGENN-NITROSODIMETHYLAMINE (NDMA) CONTAMINATION OF VALSARTAN, CLASSIFIED AS A PROBABLE HUMAN CARCINOGEN

SISMED VACCINE CODES THAT WILL BE DEACTIVATED FROM THE DRUG CATALOG

MODIFY THE SUPPLY PERIOD FOR MEDICAL DEVICES AND OTHER PRODUCTS INDICATED IN RM Nº 069-2017/MINSA, FOR THE PERIOD OF EIGHTEEN (18) MONTHS MODIFY THE SUPPLY PERIOD FOR MEDICAL DEVICES AND OTHER PRODUCTS INDICATED IN RM Nº 069-2017/ MINSA, FOR A PERIOD OF EIGHTEEN (18) MONTHS

PERUVIAN TECHNICAL STANDARDS, PERUVIAN TECHNICAL SPECIFICATION AND PERUVIAN TECHNICAL REPORT ON CEREALS AND HORSES, RISK MANAGEMENT AND OTHERS APPROVED

PROVISION OF THE PROJECT REGULATION THAT REGULATES THE PRESENTATION AND CONTENT OF THE DOCUMENTS REQUIRED IN THE REGISTRATION AND RE-REGISTRATION OF BIOLOGICAL PRODUCTS: VACCINES TO THE PUBLIC OPINION

LIST OF MEDICINES AND SUPPLIES FOR THE TREATMENT OF DIABETES

ADVERTISING WARNINGS MANUAL APPROVED WITHIN THE FRAMEWORK OF THE PROVISIONS OF THE LAW FOR THE PROMOTION OF HEALTHY FOOD FOR CHILDREN AND ADOLESCENTS, AND ITS REGULATIONS

APPROVED NEW SANITARY REQUIREMENTS OF MANDATORY COMPLIANCE FOR THE IMPORTATION OF FROZEN BOVINE SEMEN FROM AUSTRALIA

DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF MEDICINES CONTAINING "LINAGLIPTIN AND SITAGLIPTIN"

THEY ESTABLISH PHYTOSANITARY REQUIREMENTS OF NECESSARY COMPLIANCE IN THE IMPORT OF IN VITRO ORCHID PLANTS OF DIFFERENT GENRES, OF TAIWAN ORIGIN AND ORIGIN

THEY ESTABLISH PHYTOSANITARY REQUIREMENTS OF NECESSARY COMPLIANCE IN THE IMPORT OF IN VITRO PLANTS OF STEVIA OF ORIGIN AND ORIGIN OF JAPAN

THE REFERENCE LIST OF BIOMEDICAL EQUIPMENT IN THE HEALTH SECTOR IS APPROVED

ARRANGE FOR THE PUBLICATION OF PROJECT LAW Nº 30681, LAW THAT REGULATES THE MEDICINAL AND THERAPEUTIC USE OF CANNABIS AND ITS DERIVATIVES, ON THE INSTITUTIONAL PORTAL

VARIOUS PERUVIAN TECHNICAL STANDARDS APPROVED IN ITS 2018 VERSION REFERRING TO WOODEN FLOORS, FURNITURE AND FERTILIZERS

RELEASE VARIOUS PERUVIAN TECHNICAL STANDARDS WITHOUT EFFECT

APPROVE AND RELEASE SEVERAL PERUVIAN STANDARDS AND TECHNICAL SPECIFICATIONS

APPROVED ANNUAL PLAN FOR MONITORING CHEMICAL RESIDUES AND OTHER CONTAMINANTS IN PRIMARY AGRICULTURAL FOOD AND FEED FOR THE PERIOD MARCH TO DECEMBER 2018

APPROVED ZOOSANITARY REQUIREMENTS OF NECESSARY COMPLIANCE IN THE IMPORTATION OF MILK AND DAIRY PRODUCTS INTENDED FOR HUMAN CONSUMPTION FROM SWITZERLAND