Argentina - Drug Information Association

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In agreement with the EMA and the AFSSAPS, Roche wishes to inform healthcare professionals of an important update regarding the safety of AVASTIN (bevacizumab). Cases of osteonecrosis of the jaw have been reported in patients who use or have used a treatment by bisphosphonates by intravenous use. The summary of product characteristics of AVASTIN is being updated to include new tolerance information about osteonecrosis of the bone. Document date: 30-Dec-2010 Type of text: Dear Doctor Letter Regulatory version: None Language: French France - Decision of 20-Jan-2011: Removing a Tarif Forfaitaire de Responsabilité for Generic's Groups The amount of the "tarif forfaitaire de responsabilité" og the generic's group "CROMOGLICATE DE SODIUM 100 mg/5 ml" is removed as from 01-Apr-2011. Document date: 20-Jan-2011 Type of text: Decision Regulatory version: None Language: French France - AFSSAPS: Explanatory Note Regarding Pilot Phase on the Reporting of Serious Adverse Events Occurred in Biomedical Research Involving a Medical Device, Jan-2011 (French and English Versions) Pending the transposition into French legislation of Directive 2007/47/EC, the AFSSAPS carries out a pilot phase to enable the implementation of European measures and provides a table in English (strictly identical in all European countries). A French version is also available for tests taking place only in France. The sponsor may choose to report to the AFSSAPS and CPP (Committee for the Protection of Persons) serious adverse events/reactions by using the table available in the AFSSAPS website. Document date: Jan-2011 Type of text: Explanatory Note Regulatory version: None Language: Multilingual France - AFSSAPS Form: Free Sale Certificate for Exportation in the non-EC Member States - In Vitro Diagnostic Medical Devices Covered by Directive 98/79/EC, Update Jan-2011 (French and English Versions) This form is available in a ready-to-use format. At the request of manufacturers, the Afssaps provides free sale certificates intended to facilitate the exportation procedures of in vitro diagnostic medical devices in the non-EC Member States. These certificates are delivered on the basis of the elements provided by the manufacturer (declaration of CE conformity and CE mark certificate delivered by a notified body, if applicable). An explanatory note, only available in French, on how to obtain a free sale certificate for exportation of in vitro diagnostic medical devices in the non-EC Member States is annexed to this form. Document date: Jan-2011 Type of text: Form Regulatory version: None Language: Multilingual France - AFSSAPS Form: Free Sale Certificate for Exportation in the non-EC Member States - Medical Devices Covered by Directive 93/42/EEC, Update Jan- 2011 (French and English Versions) This form is available in a ready-to-use format. At the request of manufacturers, the Afssaps provides free sale certificates intended to facilitate the exportation procedures of medical devices in the non-EC Member States. These certificates are delivered on the basis of the elements provided by the manufacturer (declaration of CE conformity and CE mark certificate). An explanatory note, only available in French, on how to obtain a free sale certificate for exportation of medical devices in the non-EC Member States is annexed to this form. Document date: Jan-2011 Type of text: Form Regulatory version: None Language: Multilingual France - AFSSAPS: Guide for Custom-Made Devices (Dispositifs Médicaux sur Mesure) Marketing, Version of 18-Jan-2011
This document has been drawn up to constitute a guide intended to the manufacturers of custom-made devices (dispositifs médicaux sur mesure). Moreover, a recodification was carried out in the Public Health Code. The provisions applicable to medical devices can now be found in the fifth part of this Code (26088 and 45695). Document date: 18-Jan-2011 Type of text: Guideline Regulatory version: Revision Language: French France - HAS Transparency Commission: Minutes of the Meeting of 19-May-2010 This document provides the minutes of the Transparency Commission meeting of May 19, 2010. Agenda: 1. List of attendees 2. Regulation and ethics 3. List of solicited rapporteurs 4. Examination of requests 5. Contradictory phases 5.1. Hearings of laboratories 6. Approval of opinion statements 6.1 Review of the meeting of May 05, 2010 6.2 Simplified Procedures 7. Other points 7.1 Reevaluation of beta interferon or glatiramer acetate in multiple sclerosis 7.2 Therapeutic <strong>Information</strong> Sheet Document date: 19-May-2010 Type of text: Minutes Regulatory version: None Language: French France - Order of 21-Jan-2011: Granting & Modification of Opening Authorizations of the Pharmaceutical Establishments Referred to in Art. R. 5124- 2 of the CSP This Order defines the dossiers to be submitted, the requirements to be fulfilled and the procedures to be followed to obtain an authorization for the opening or modification of a pharmaceutical establishement. It applies for all pharmaceutical establishments referred to in the art. R. 5124-2 of the Code of Public Health, except those concerning with the minister in charge of the armies. Comment: This Order replaces "Order of 18-May-2000: Opening and Modification of the Pharmaceutical Establishments Referred to in Art. R. 5106 of the CSP" (25278). Document date: 21-Jan-2011 Type of text: Order Regulatory version: None Language: French France - AFSSAPS: Clarification on the Pharmacovigilance System in France, Jan- 2011 After the MEDIATOR scandal, the AFSSAPS brings some clarification on the national pharmacovigilance system. This document is composed of information on: - The new EU legislation relating to pharmacovigilance published on December 15, 2010; - The marketing authorisation of a medicinal product; - The organization of pharmacovigilance; - And a glossary The AFSSAPS has also made available a list of medicinal products or class of medicinal products subject to special monitoring (see 119298). Document date: Jan-2011 Type of text: Other Texts Regulatory version: None Language: French France - AFSSAPS: List of Proprietary Medicinal Products with a Reinforced Monitoring of Pharmacovigilance, Update 02-Feb-2011 After the MEDIATOR scandal, the AFSSAPS provides the list of medicinal products or class of medicinal products subject to special monitoring or investigation. The reasons of this reinforcement, as well as ongoing actions, are also detailed in this document. The AFSSAPS has published some clarification on the national pharmacovigilance system (see 119323). Document date: 02-Feb-2011 Type of text: Other Texts Regulatory version: None Language: French France - AFSSAPS Frequently Asked Questions (FAQ): Specific Questions Related to Modalities for Marketing of Custom-Made Medical Devices, May-2010 This document provides the list of frequently asked questions concerning the modalities for the marketing of custom-made medical devices, especially dental prosthesis. Document date: May-2010 Type of text: Questions & Answers
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Argentina - Drug Information Association

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