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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  a través del comunicado publicado el 27 de mayo de 2019 en su Portal Institucional; hace de conocimiento, en cumplimiento con lo dispuesto en el artículo 20° de la Ley N° 27444 “Ley del Procedimiento Administrativo”, la publicación del Listado de Resoluciones Directorales de imposición de multa habiendo agotado las indagaciones de los domicilios de los administrados.

Source: DIGEMID

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

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

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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

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

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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

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

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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

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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)"

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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

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

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

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

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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

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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

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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

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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