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Displaying 71 - 80 of 113 results.
Authority Report for the meeting of 14 March 2019
a number of key items from the paper, specifically the progress of the medicines supply-chain, medicines authorised by the HPRA in light of Brexit. A discussion followed on the approach the HPRA, of the review involves meetings with the Chairs of the subcommittees (herbal and clinical trials, Committee Veterinary Medicines (ACVM) – 13/02/19 The Chair provided a briefing on the main topic
IMB Newsletter-Issue No. 20-January-June 2005
Day 2005 3 New Medicines Legislation 3 Herbal Medicines 6 Homeopathic Medicines 7 Veterinary, of medicines regulation in Ire- land. Professor OÕMalley served as a board member of the IMB and its, to 1995. He served as a Board member and Chairman of the Advisory Com- mittee for Human Medicines, arena and the enormous contribution he made to progress in the medicines regulatory environ- ment, of medicines but also in respect of other policy and business matters. His contributions were extremely
HPRA Annual Report 2015
were hosted during 2015 focused on topics such as herbal medicines, cosmetic products, AND VETERINARY MEDICINES 120 NEW MEDICINES FOR VETERINARY USE AUTHORISED 83 CLINICAL TRIALS WERE APPROVED TO COMMENCE IN IRELAND ON MEDICINES FOR HUMAN USE 108 VARIATIONS TO MARKETING AUTHORISATIONS ISSUED FOR HUMAN AND VETERINARY MEDICINES 17,122 HPRA RANK IN EU FOR RAPPORTEURSHIPS FOR CENTRALLY AUTHORISED HUMAN PRODUCTS 7th THE TOTAL NUMBER OF NEW HUMAN MEDICINES
Application for a Wholesale Distribution Authorisation
medicines only? FORMCHECKBOX Yes FORMCHECKBOX No Do wholesaling activities occur, Traditional herbal medicinal products FORMCHECKBOX 3.4.10 Homeopathic medicinal products (HOR, of medicinal products uses the service of a broker, that broker is required by the Falsified Medicines
IMB Newsletter-Issue No. 21-July-September 2005
Confidentiality Agreement with FDA 1 General Staff Update 1 Human Medicines Legislation and Guidelines 2 New Medicines Legislation 3 Variations 3 Pharmacovigilance 6 Homeopathic Medicines 7 Veterinary Medicines Legislation and Guidelines 8 Legislation Changes 8 Mutual Recognition and Decentralised, Statistics 12-18 IMB signs Confidentiality Agreement with FDA IRISH MEDICINES BOARD, KEVIN OÕMALLEY, Medicines Department. LORCAN ALLEN was appointed Toxicologist in the Human Medicines Department
Terms of Reference and Rules of Procedure of the HPRA Leadership Team
medicines, clinical investigations on medical devices, and cases relating to scientific animal, Committee for Human Medicines, the Advisory Committee for Veterinary Medicines, or the Advisory, DEVOLVED BY THE HPRA LEADERSHIP TEAM TO STAFF HUMAN MEDICINES The modification of authorisations, medicinal products The variation of certificates of registration for herbal medicinal products, VETERINARY MEDICINES The variation of licences to conduct veterinary clinical field trials
IMB Newsletter-Issue No. 12-May-August 2002
and Leaflets 3 Clinical Tr i a l s 3 P h a rmacovigilance News 3 Herbal Medicines Pro j e c t 3, to type (ini- t i a l / f o l l o w - u p ) . Herbal Medicines H E R B A L M E D I C I N E S P R O J E C T The IMB Herbal Medicines Project was completed in January 2002 following an extensive, on Herbal Medicinal Products and the Advisory Committee on Human Medicines. The IMB and its, . A clear overview of the proposals for changes in the veterinary medicines leg- islation was given
Annual Report 2009 IMB
Medicines Board’s role is to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products. Annual Report 2009 1 50 Information, Monitoring 25 Human Products Authorisation and Registration 34 Veterinary Medicines 37, Executive’s Report contents 2 Irish Medicines Board in 2008. We continue to co-operate closely, and liaison exchange programmes for relevant personnel. Our work in the area of licensing medicines
Annual Report 2021
2021-2025 – Key achievements in 2021 12 COVID-19 Response 13 Human Medicines 16 Medical Devices 27 Blood, Tissues and Organs 32 Veterinary Medicines 33 Scientifc Animal Protection 37 Controlled, -rapporteur The number of EMA scientifc advice procedures for human medicines co-ordinated by the HPRA, related to new veterinary medicines authorisation No. 1 applications issued for clinical trials of human medicines 107 new human medicines authorised during 2021 542 2 Top 10 21 The HPRA
HPRA Medicinal Products Newsletter - Issue Number 54
HPRA Medicinal Products Newsletter - Issue Number 54 ,  The European Medicines Agency (EMA, NEWSLE TTER Human Medicines • EMA - QPPV update – What’s new in Pharmacovigilance – Issue 2, or supply of traditional herbal medicinal products (THMPs) that have been granted their certifcate, In this Issue Human Medicines EMA - QPPV update – What’s new in Pharmacovigilance – Issue 2 – August 2016 Human Medicines The European Medicines Agency (EMA) highlighted a change implemented