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Periodic Safety Update Reports (PSURs)
: Article 10.1 generics Article 10.a well-established use Article 14 homeopathic medicines Article 16a traditional herbal medicines Further information on GVP and the EURD list may be found on the European Medicines Agency website. Please note that the EURD list is a living, is authorised in more than one Member State. The European Medicines Agency maintains a list of EU reference dates and frequency of submission of PSURs (EURD list) for active substances contained in medicines
IMB Newsletter-Issue No. 8-Octomber 2000-March 2001
............................................................................................................... 7 Herbal Medicines Herbal Medicines Project Update, . HERBAL MEDICINES Herbal Medicines Project Update The Herbal Medicines Project first interim report, throughout the Herbal Medicines Table 1. Scientific Committee on Herbal Medicinal Products Member, IMB Newsletter-Issue No. 8-Octomber 2000-March 2001,  IRISH MEDICINES BOARD Bord Leigheasra na h
IMB Newsletter-Issue No. 11-January-April 2002
Herbal Medicines Herbal Medicines Project Update, MEDICINES Herbal Medicines Project Update Herbal Medicines Project Seminar Following submission of final report of the Herbal Medicines Project to the Department of Health and Children in January, The European Medicines Evaluation Agency (EMEA) recently agreed that the Herbal Medicinal Products Working, IMB Newsletter-Issue No. 11-January-April 2002,  IRISH MEDICINES BOARD Bord Leigheasra na
ANVISA Brazil - 2012 MoU with ANVISA
Sanitaria IRISH MEDICINES BOARD MEMORANDUM OF UNDERSTANDING between The Brazilian Health Surveillance Agency (ANVISA) And the Irish Medicines Board of Ireland (1MB) CONCERNING COOPE,RATION, ,ria (ANVISA) of Brazil and The Irish Medicines Board (1MB) of Ireland (hereinafter referred, products, herbal medicinal products, medical devices or other products or devices related, 79.094/1977 as amended from time to time; and (ii) medicinal products, herbal medicinal
IMB Newsletter-Issue No. 23-January-April 2006
Changes 2 Human Medicines Legislation and Guidelines 2 Pharmacovigilance Safety Variations 2, - Further Guidance 3 User Testing Package Leaflets 4 Veterinary Medicines Legislation, Committee for Veterinary Medicines 6 Compliance GMP certificates 6 QP discretion / Compliance with the Marketing Authorisation 6 Information Day 6 Statistics 7Ð13 IRISH MEDICINES BOARD, KEVIN, under the Irish Medicines Board Act 1995, which came into operation in early 1996. The IMB celebrated
Annual Report 2011 IMB
THE REGULATION TRADITIONAL HERBAL MEDICINES 228 REPORTS OF SUSPECTED ADVERSE REACTIONS, SUPPORT THE REGULATION TRADITIONAL HERBAL MEDICINES 228 REPORTS OF SUSPECTED ADVERSE REACTIONS, THE REGULATION TRADITIONAL HERBAL MEDICINES 228 REPORTS OF SUSPECTED ADVERSE REACTIONS ASSOCIATED, for herbal medicines. A substantial programme of stakeholder engagement and information, health. 13 IMB ANNUAL REPORT 2011 Consumer Research – Regulation of Herbal Medicines The fndings
Variations
About Us Medicines Veterinary Medical Devices Blood, Tissues, Organs, Regulatory Information Medicines Authorisation Variations My HPRA Logout About Us Medicines Veterinary Our Role Veterinary Medicines Information Safety Information Regulatory Information Medicines Authorisation Advertising Allocating the method of supply Batch Specific Request Herbal and Homeopathic
IMB Board Report - 5 June 2014
Report and the Herbal Medicines Subcommittee Report. The Committee received presentations on medicinal, . The Chief Executive spoke about the progress made in interchangeable medicines at the Irish, Coalition of Medicines Regulatory Authorities (ICMRA). Also at a European level the IMB is attending, Committee Human Medicines – 22 May 2014 The Chairperson of the Committee provided a brief overview, to unauthorised medicines/exempt medicinal products, interchangeable medicines, the proposal
New Product
About Us Medicines Veterinary Medical Devices Blood, Tissues, Organs, Veterinary Regulatory Information Medicines Authorisation New Product My HPRA Logout About Us Medicines Veterinary Our Role Veterinary Medicines Information Safety Information Regulatory Information Medicines Authorisation Advertising Allocating the method of supply Batch Specific Request Herbal
Therapeutic Goods Administration Australia - 2010 MoU with TGA Australia
Department of Health and Ageing Therapeutic Goods Administration IRISH MEDICINES BOARD, and the Irish Medicines Board of Ireland CONCERNING COOPERATION IN THE REGULATION OF THERAPEUTIC PRODUCTS 1. BACKGROUND The Therapeutic Goods Administration (TGA) of Australia and The Irish Medicines, Therapeutic Goods Act 1989, as amended from time to time; and b. medicinal products, herbal medicinal, Medicines Board Act, 1995 as amended from time to time. 4. AREA OF COOPERATION The Participants