Nova Legislação sobre Farmacovigilância

12 Abr Nova Legislação sobre Farmacovigilância

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Nova Legislação sobre Farmacovigilância (Regulamento (UE) 1235/2010 e Directiva 2010/84/EU)

Em 5 de Março de 2012, a Agência Europeia do Medicamento publicou um conjunto de requisitos relacionados com a submissão obrigatória de informações sobre medicamentos para uso humano. A legislação que enquadra estes novos requisitos constitui a maior mudança na regulação dos medicamentos de uso humano na União Europeia (UE) desde 1995. Esta legislação tem implicações significativas para os titulares de autorizações de introdução no mercado de medicamentos na UE. A Agência Europeia de Medicamentos é a principal responsável pela implementação desta nova legislação que será aplicável a partir de Julho de 2012. O artigo 57 (2) do Regulamento (CE) 1235/2010 requer:

• A publicação pela Agência de um formato para apresentação electrónica das informações sobre medicamentos para uso humano até 2 de Julho de 2011;
• O envio pelos titulares de autorizações de introdução no mercado à Agência (por via electrónica) de informações sobre todos os medicamentos para uso humano autorizados na União Europeia até 2 de Julho de 2012, usando este formato;

Consulte os documentos no website da EMA (abaixo)

Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004

Extended EudraVigilance medicinal product report message (XEVPRM): Frequently asked questions and answers (FAQs)

Article 57(2) requirements: information to marketing authorisation holders on the updated format for electronic submission of information on medicines

New pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament and European Council in December 2010.

On 5 March 2012, the Agency published an updated set of mandatory Article 57(2) requirements for the electronic submission of information on medicinal products for human use. The legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of EU marketing authorisations. The European Medicines Agency is responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation applies from July 2012. One of the key deliverables of the new legislation relates to the submission by marketing authorisation holders of information about medicines to the Agency. The requirement is described in Article 57(2) of Regulation (EC) No 1235/2010. It requires:

·         the Agency to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011;

·         marketing authorisation holders to submit information to the Agency electronically on all medicinal products for human use authorised in the European Union by 2 July 2012, using this format;

·         marketing authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format.

You can find the detailed documents on EMA´s web site, linked below.

LEGAL NOTICE:

Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004

FAQ:

Extended EudraVigilance medicinal product report message (XEVPRM): Frequently asked questions and answers (FAQs)

Article 57(2) requirements: information to marketing authorisation holders on the updated format for electronic submission of information on medicines

Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004:

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