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List of Foreign Manufacturing Laboratories of Pharmaceutical Products that are pending GMP Certification by DIGEMID (Period: 2010 to August 31, 2019)

La Dirección de Inspección y Certificación de la DIGEMID a través del comunicado publicado el 17 de setiembre de 2019 en su portal institucional, hace de conocimiento, a través del Oficio N° 1937-2019-DIGEMID-DG-DICER-UFLAB/MINSA de fecha 09 de setiembre de 2019 remitido a la SUNAT – ADUANAS, el “Listado de los Laboratorios Fabricantes Extranjeros de Productos Farmacéuticos que se encuentran pendientes de Certificación en Buenas Prácticas de Manufactura por parte de la ANM”.

Source: DIGEMID

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DIGEMID safety modifications: For pharmaceutical specialties containing "MELOXICAM"

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

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

DIGEMID statement regarding the exceptional authorization

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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

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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

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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"

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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"

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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"

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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

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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

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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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INFORMATION ON REQUESTS FOR COMMUNICATIONS

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

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FREE SALE CERTIFICATE (CLV) – COSMETIC PRODUCTS

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