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IMB Newsletter-Issue No. 6-Spring 2000
/Comments should be marked for the attention of: Publications Officer, Irish Medicines Board, Internet: www.imb.ie IRISH MEDICINES BOARD Bord Leigheasra na hƒireann 1 CONTENTS: PAGE General, Human Medicines TSE - Minimising the Risk of Transmission, Medicines Legislation/Guidelines, . JohnÕs Wort The Irish Medicines Board (IMB) considers that St JohnÕs wort is a medicinal product which
Terms of Reference and Rules of Procedure of the HPRA
Performance Evaluation Committee Herbal Medicines Subcommittee Human Resources, referred to as ‘the Authority’) is established by Section 3 of the Irish Medicines Board Act, 1995, ; 1 The body was originally established as the Irish Medicines Board (‘the Board’); the name, on Human Medicines, an Advisory Committee on Veterinary Medicines and an Advisory Committee, Medicines Board Act, 1995, the European Communities Act, 1972 or the Misuse of Drugs Act 1977. (HPRA
Guide to applications for a variation to a manufacturer's authorisation
published by the European Medicines Agency on behalf of the European Commission. The Union Format, Standard variation process Applies to all variation types for human medicines, veterinary medicines and IMP manufacturer’s authorisations. Timeline is dependent on the type of variation, Registrations for Human Medicines’ available on www.hpra.ie. The HPRA reserves the right, activity Note: where a manufacturer carries out processing steps in relation to herbal or homoeopathic
IMB Newsletter-Issue No. 16-September-December 2003
for use 4 Herbal Medicines Update 4 Ve t e r i n a r y Medicines New Mutual Recognition D o c u m e n, R O D U C T S The IMB Human Medicines Infor- mation Day was held in the Gre a t S o u t h e rn, Medicines Inform a- tion Day in late 2004/early 2005. G E N E R A L We at IMB wish all our client, throughout the year Human Medicines Information Day CONTENTS G e n e r a l A message from the IMB 1 Human Medicines Information Day 1 Ve t e r i n a ry Information Day 1 R e c ruitment at IMB 1
Tuarascáil Bhliantúil 2012 IMB
HERBAL MEDICINES 228 REPORTS OF SUSPECTED ADVERSE REACTIONS ASSOCIATED WITH USE OF VETERINARY, MEDICINES 77% OF IRISH ADULTS SUPPORT THE REGULATION TRADITIONAL HERBAL MEDICINES 228 REPORTS, ADULTS SUPPORT THE REGULATION TRADITIONAL HERBAL MEDICINES 228 REPORTS OF SUSPECTED ADVERSE, Tuarascáil Bhliantúil 2012 IMB,  Irish Medicines Board Bord Leigheasra na hÉireann Teach Kevin, DOCUMENTS PUBLISHED 253 MEDICINES RECALLED DUE TO QUALITY DEFECTS 4,549 NEW ENFORCEMENT CASES
Guide to Fees for Human Products
’ for an explanation of how these codes apply to parallel imports. 1.8 Herbal medicines Code 253 is for an application for a traditional-use registration for herbal medicines under Article 16a, ABBREVIATIONS 3 INTRODUCTION 4 1 AUTHORISATION OR REGISTRATION OF MEDICINES 4 2 CLINICAL TRIAL, for Medicinal Products for Human Use (at the European Medicines Agency) CMS Concerned Member State DCP Decentralised Procedure EDQM European Directorate for the Quality of Medicines & HealthCare
HPRA Brexit Guidance - Human and Veterinary Medicines - Update October 2020
HPRA Brexit Guidance - Human and Veterinary Medicines - Update October 2020,  DATE: October 2020, by the HPRA without notice. Brexit Guidance for Stakeholders Human and Veterinary Medicines HPRA, REGULATORY NETWORK 3 3 KEY INFORMATION FOR HPRA STAKEHOLDERS 4 4 MEDICINES AVAILABILITY 5 5, FOR HUMAN MEDICINES 12 7.1 UK based sponsor or legal representative listed on clinical trial, medicines 14 8.2 Veterinary medicines 15 9 CHANGES TO IMPORT AND EXPORT REQUIREMENTS 15 9.1 Customs
Guide to National Rules Scheme for Homeopathic Medicinal Products for Human Use
. 2 INTRODUCTION The Directive on human medicines 2001/83/EC, as amended by Directive 2004/27/EC, that they are familiar with the relevant EU legislation and guidelines published for human medicines including, Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA): - Module 1.2 Homeopathic, on ‘Safety issues in the preparation of homeopathic medicines’, which should be consulted, for certain homeopathic medicinal products is available on the Heads of Medicines Agencies website
IMB Newsletter-Issue No. 19-September 2004-January 2005
- ciated with herbal medicines: a cross- sectional survey of national pharma- covigilance centresÕ, MEDICINES BOARD, EARLSFORT CENTRE, EARLSFORT TERRACE, DUBLIN 2 TEL: 01 676 4971 FAX: 01 676 7836 EMAIL, Drugs Advisory Board and the Irish Medicines Board. Professor OÕMalley was appointed, as Chairman from July 1985 to December 1995. Following its establishment under the Irish Medicines, New Medicines Legislation 1 Human Medicines Legislation and Guidelines 1 Mock Ups 2 Withdrawal
Guide to New Applications and Variations to Wholesale Distribution Authorisations
Authorisation (PPA) Refer to the ‘Guide to Parallel Imports of Human Medicines’ available on the HPRA, Registration (DPR) Refer to the ‘Guide to Parallel Imports of Human Medicines’ available on the HPRA, AUT-G0152-5 9/18 3.4.9 Traditional herbal medicinal products 3.4.10 Homeopathic medicinal products, , all the activities which could affect the quality of the medicines. It is desirable, Medicines Directive to register with the HPRA. The name and address of any brokers used must