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THEY APPROVE THE “BIOLOGICAL PRODUCT LOT RELEASE CERTIFICATE” FORMAT

La Dirección General de la DIGEMID a través de la Resolución Directoral Nº 005-2019-DIGEMID-DG-MINSA publicada el 16 de enero de 2019 en el Diario Oficial”El Peruano”, aprobó el formato “Certificado de Liberación de Lote de Producto Biológico”
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Fuente: Diario Oficial «El Peruano»

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

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

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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

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THEY APPROVE THE “BIOLOGICAL PRODUCT LOT RELEASE CERTIFICATE” FORMAT

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FREE SALE CERTIFICATE (CLV) – COSMETIC PRODUCTS

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TECHNICAL DOCUMENT "NATIONAL LIST OF VITAL PHARMACEUTICAL PRODUCTS" APPROVED

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

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

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

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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