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ANMAT: the Argentinean Health Authority Regulatory Affairs in …

WEBThe ANMAT, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Food and Medical Technology) is the descentralized …

Actived: 5 days ago

URL: https://latampharmara.com/argentina/anmat-the-argentinean-health-authority/

Drug Registration in Mexico Regulatory Affairs in Latin America

WEBThe CPP is a document that certifies that a pharmaceutical product is registered and/or commercialized in a country. Representation letter, assigning the legal representative of …

Category:  Health Go Health

COFEPRIS: the Mexican health authority Regulatory Affairs in …

WEBCOFEPRIS stands for Comisión Federal para la Protección contra Riesgos Sanitarios: Federal Commission for Protection against Sanitary Risks and is the authority with …

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The Submission Dossier Regulatory Affairs in Latin America

WEBThe Submission Dossier. The submission dossier is the packet of documents that are to be submitted to a health authority for registration of a product, or for other life-cycle …

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Argentina Regulatory Affairs in Latin America

WEBThe HealthCare system in Argentina Argentina's health care system is composed of three sectors: the public sector, financed through taxes; the private sector, financed through …

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Drug registration in Argentina

WEBDrug registration in Argentina is regulated by Decree 150/1992 and posterior modifications. (link to Decree - Spanish) For information on registration of biological drug products, …

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Health Authorities of International Reference Regulatory Affairs in

WEBSome national health authorities and other international entities are considered relevant for the pharmaceutical industry around the whole world. For example, the American Food …

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EMA Regulatory Affairs in Latin America

WEBEMA, the European Medicines Agency, (previously called EMEA) is a European Union agency for the regulation and control of medicinal products. It was established in 1995 …

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GMP inspections by COFEPRIS

WEBGMP verification is required by COFEPRIS in the following cases: • For new registration and manufacturing changes of biologic, biotech and hemoderivate products. • For new …

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FDA Regulatory Affairs in Latin America

WEBThe FDA, or Food and Drug Administration, is the agency of the United States of America responsible for regulation and supervision of food safety, tobacco products, dietary …

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GMP inspections: regulatory aspects

WEBAgreement among MERCOSUR countries: when a drug product is manufactured in a country member of the MERCOSUR, other MERCOSUR countries may publish and …

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Mexico Regulatory Affairs in Latin America

WEBThe Mexican pharmaceutical market is worth approximately 13 billion dollars (estimate 2012) what makes it one of the top 20 biggest pharma markets in the world, and the 2nd …

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Brazil: Overview of API registration

WEBPosted on October 28, 2013 by Maria I. Guaia. In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, …

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Stability Studies Regulatory Affairs in Latin America

WEBStability Studies. The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of …

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Variations Regulatory Affairs in Latin America

WEBHere there is a list of the administrative and CMC variations that require notification and approval from the Argentinean health authority, and the list of documents to submit. …

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MERCOSUR Regulatory Affairs in Latin America

WEBMERCOSUR stands for Mercado Común del Sur, or Southern Common Market, and is an economic and political agreement among Argentina, Brazil, Paraguay, (currently …

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Drug registration in Colombia

WEBThe procedure, timelines and documents required for registration of drug products in Colombia depend on the type and origin of the drug product. The regulations distinguish …

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Pharmacovigilance Regulatory Affairs in Latin America

WEBIn Argentina, the National System of Pharmacovigilance was created in 1993 by the Ministry of Health and Social Action, through the Resolution 706/1993. Its functions are …

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Pharmacovigilance Regulatory Affairs in Latin America

WEBIn Mexico, Marketing Authorization Holders have the following responsibilities related to pharmacovigilance: - Inform the competent authorities the identities of the people …

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