Argentina - Drug Information Association

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document are the following: the decision from the Croatian NCA on the relevant entries has been added. Comment: This document replaces the previous version of Feb-2008 (55073). Document date: 26-Jan-2011 Type of text: Guideline Regulatory version: Revision Language: English European Union - EMA/27236/2003 rev. 12: Tables of Non-standard Abbreviations, 26-Jan-2011 This document provides a list of non-standard abbreviations to be used in the Summary of Product Characteristics and the small immediate packaging labelling. In this new revised document the abbreviations for Croatia have been added. Comment: This document replaces the previous version of April 2009 (90871). Document date: 26-Jan-2011 Type of text: Guideline Regulatory version: Revision Language: English European Union - EMA/48630/2011: Pre-accession Product <strong>Information</strong> Linguistic Review Process (PALC III), 18-Jan-2011 This guidance document provides information on the extension of Commission Decisions on marketing authorisations of medicines that are approved through the centralised procedure in 2012 to Croatia. The goal is to make the phasing in of Commission Decisions easier. This is done so that delays of supply of medicines in Croatia are avoided, and so that the circulation of medicines possessing translations of poor quality are also prevented. This document also contains the timetable for the sending of translation slots to the Croatian National Competent Authority. Comment: Please see also "EMA Form 1: For Marketing Authorisation Holders When Submitting Translation to the National Competent Authority of Croatia by Day 1, Jan-2011" (119328) and "EMA Form 2: For Marketing Authorisation Holders when Submitting Corrected Translations to the National Competent Authority of Croatia by Day 70, Jan-2011" (119299). Document date: 18-Jan-2011 Type of text: Guideline Regulatory version: None Language: English European Union - EMA/9826/2011: Practical Guidance on Extension of Commission Decision Annexes in New Accession Country Language, 27-Jan-2011 This guidance document provides information on the phasing-in of Commission Decisions regarding Centrally Authorised Products (CAPs) in Croatia. Details are given on the inclusion of the new Croatian language and new specimens into the centralised procedure's operational aspects. This guideline covers the following topics: - CAPs with ongoing regulatory activity, with opinion before Croatia’s accession date (i.e. Commission Decision expected on or after Croatia’s accession date) - CAP with ongoing/imminent regulatory activity (CxMP Opinions) after Croatia’s accession date - CAP with no ongoing regulatory activity - Overview of translation requirements for the phasing-in process of the new Accession Country language Document date: 27-Jan-2011 Type of text: Guideline Regulatory version: None Language: English European Union - EMEA/CHMP/225411/2006: EMA Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications, Jan-2011 This document adresses a number of questions which users of the Centralised procedure may have. It provides an overview of the EMA position on issues, which are typically adressed during the course of the Pre-Submission meetings. It should be highlighted that this document has been produced for procedural advice only and should be read in conjunction with "The rules governing medicinal products in the European Union, Volume 2A, Notice to Applicants". Applicants must in all cases comply with all requirements of Community Legislation. Provisions, which extend to European Economic Area (EEA) countries (i.e. the EU Member States, plus Norway, Iceland and Liectenstein) by virtue of the EEA agreement, are outlines in the relevant sections of the text. Comment: This document cancels the previous version: "EMEA/CHMP/225411/2006: Pre- and Post-Authorisation Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications, 02-Jul-2008" (83943). Document date: Jan-2011 Type of text: Guideline Regulatory version: None Language: English European Union - Timetable for Sending of Translations to Croatia, Jan-2011
This guidance document provides the timetable for translations to be sent to Croatia, for both human and veterinary products. Document date: Jan-2011 Type of text: Guideline Regulatory version: None Language: English European Union - EMA/123695/2004 rev.11: Names of EU-EEA Countries, 24- Jan-2011 This document provides a list of the countries of the EU/EEA, including the translation of the names in the different EU languages. Changes since last revision: inclusion of translations of Croatia. Comment: This document replaces the previous version of Jul-2008 (83780). Document date: 24-Jan-2011 Type of text: List Regulatory version: Revision Language: English European Union - EMA: List of EMEA Experts in Alphabetical Order by Nominating Authority, 20-Jan-2011 As part of the initiatives taken by the EMEA to increase the transparency of its operations, the Management Board has decided to make available the list of experts on the Internet, together with the name and address of their nominating authority. These experts serve either as members of the Management Board, of the EMEA scientific committees, of the working parties or as part of the scientific assessment teams. This list of European experts is hereby presented in Alphabetical Order by Country. These documents form part of a database which can be regularly updated by Member States. Document date: 20-Jan-2011 Type of text: List Regulatory version: Revision Language: English European Union - EMA: List of EMEA Experts in Alphabetical Order, 20-Jan-2011 As part of the initiatives taken by the EMA to increase the transparency of its operations, the Management Board has decided to make available the list of experts on the Internet, together with the name and address of their nominating authority. These experts serve either as members of the Management Board, of the EMA scientific committees, of the working parties or as part of the scientific assessment teams. These documents form part of a database which can be regularly updated by Member States. Document date: 20-Jan-2011 Type of text: List Regulatory version: Revision Language: English European Union - EMA/683287/2010 - P/336/2010: Decision on the Application for a Product Specific Waiver for interferon alpha 2b, 22-Dec-2010. The Paediatric Committee has given a positive opinion for granting a waiver for the active substance interferon alpha 2b. - Applicant: Helix BioPharma Corp. - Condition: Treatment of cervical intraepithelial neoplasia (CIN grade I and II). - Pharmaceutical form: Vaginal cream. - Route of administration: Vaginal use. Document date: 22-Dec-2010 Type of text: Opinion, PDCO Opinion Regulatory version: None Language: English European Union - EMA/708709/2010 - P/344/2010: Decision on the Application for Agreement of a Paediatric Investigation Plan for Aqueous allergen extract of dermatophagoides pteronyssinus, 22-Dec-2010 The Paediatric Committee has given a Positive Opinion for a request for agreement of Paediatric Investigation Plan for the active substance Aqueous allergen extract of dermatophagoides pteronyssinus. - Applicant: ROXALL Medizin GmbH - Condition: Treatment of allergic rhinitis/rhino-conjunctivitis - Pharmaceutical form: Oral solution - Route of administration: Sublingual use More detailed information regarding the Paediatric Investigation Plan (PIP): - Proposed PIP indication: Treatment of allergic rhinitis/rhino-conjunctivitis due to house dust mite allergens. - Age subset: From 5 to less than 18 years of age. - Date of completion of the PIP: By September 2025 - Deferral: Yes Document date: 22-Dec-2010 Type of text: Opinion, PDCO Opinion
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Argentina - Drug Information Association

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