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Legislación Española |
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Normativa Europea |
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Rules Governing Medicinal Products in the European Union, published by the European Commission, Directorate Enterprise, Regulatory Framework and Market Authorisations (Version December 2001) |
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of the European Parliament and of the Council of 6 November 2002 on the Community Code relating to medicinal products for human use |
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, of 10 March 1995, laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93. |
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, of 22 July 1993 , laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Amended by Commission Regulation (EC) No 649/98 of 23 March 1998 amending the Annex to Council Regulation (EEC) No 2309/93 |
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Guías Europeas |
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Final Note for Guidance on Regulatory Electronic Transmission of Individual Case Safety Reports (ICSRs) in Pharmacovigilance (EudraVigilance TIG adopted March 2002) |
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Position Paper on Compliance with Pharmacovigilance Regulatory Obligations (Adopted November 2001) |
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Revision 1 (EV-TIG) - Joint Pharmacovigilance Plan for the Implementation of the ICH E2B, M1 and M2 Requirements related to the Electronic Transmission of Individual Case Safety Reports in the Community (Submitted for Approval by CPMP, April 2001) |
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Note for Guidance on Electronic Exchange of Pharmacovigilance Information for Human and Veterinary Medicinal Products in the European Union |
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Revision 1 - Note for Guidance on the Rapid Alert System (RAS) and Non-Urgent Information System (NUIS) in Human Pharmacovigilance |
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Revision1 - Note for Guidance on Procedure for Competent Authorities on the Undertaking of Pharmacovigilance Activities (Revision adopted by CPMP Feb. 99) |
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Principles of providing the World Health Organisation with Pharmacovigilance Information |
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Conduct of Pharmacovigilance for Centrally Authorised Products |
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Communication addressed to all MAH in the EEA - Implementation of the Electronic Transmission of Individual Case Safety Report in the EEA |
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Policy paper on the implementation of the Electronic Transmission of Individual Case Safety Reports for Medicinal Products for Human Use Authorised in the European Union. |
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Concept Paper on Conduct of Pharmacovigilance for Medicines used by Children |
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Guías de la Conferencia Internacional de Armonización (ICH) |
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Step 5 Note for Guidance on Population Exposure: The extent of Population Exposure to assess Clinical Safety (CPMP/ICH/375/95 adopted November 94) |
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Step 5 Note for Guidance on Good Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95 - adopted November 94) |
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Step 5 Modification Note for Guidance on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICH ICSR DTD Version 2.3)(CPMP/ICH/287/95 - Mod. released for information November 2000) |
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Step 5 Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports- Questions and Answers. Release for information November 2003 |
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Step 4 Note for Guidance on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (CPMP/ICH/288/95 - adopted December 96) |
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Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs (CPMP/ICH/4679/02 - final approval of addendum by CPMP February 2003) (Addendum to ) |
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Post approval safety data management. Note for Guidance on Definition and Standards for Expedited Reporting (CPMP/ICH/3945/03 -Final approval by CPMP November 2003) |
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Pharmacovigilance Planning (PVP). Note for Guidance on Planning Pharmacovigilance Activities (CPMP/ICH/5716/03 - released for consultation November 03) |
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, Step 5 Modification Note for Guidance on Recommendations on Electronic Transmission of Individual Case Safety Reports Message Specification. (CPMP/ICH/285/95 - Mod. released November 2000) (Large file: 335KB) |
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OTROS DOCUMENTOS |
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OTROS ENLACES DE INTERÉS |
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REVISTAS DE FARMACOVIGILANCIA |
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OTRAS PÁGINAS DE FARMACOVIGILANCIA |
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