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PUBLICAN CRONOGRAMA DE LABORATORIOS Y DROGUERÍAS PARA TRÁMITES EN RELACIÓN A LOS ESTUPEFACIENTES, PSICOTRÓPICOS Y PRECURSORES
Mediante comunicado publicado el 06 de Abril de 2018 en el Portal Institucional de la DIGEMID, la citada institución difundió el Cronograma – 2018 para trámites de los productos farmacéuticos que contengan estupefacientes, psicotrópicos y precursores y que deben realizar los establecimientos farmacéuticos: laboratorios y droguerías.
Entre los trámites mencionados se encuentran:
Balances trimestrales de estupefacientes, psicotrópicos y precursores.
Información de consumo y saldo de estupefaciente, psicotrópico, precursor para droguerías y laboratorios que importan (Año 2018).
Solicitud de provisiones de importación y exportación para el año 2018.
Solicitud de designación de supervisor para verificación de pesaje e incorporación de sustancias comprendidas en el D. S. Nº 023-2001-SA Art. 18º – (Formato D6) para el año 2018.
Solicitud para calificación de saldos descartables y designación de supervisor como veedor de procedimientos de destrucción de sustancias y/o medicamentos que las contienen comprendidos en el D. S. Nº 023-2001-SA.
Source: DIGEMID
Recent posts
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
