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IMB Newsletter-Issue No. 17-January-April 2004
IRISH MEDICINES BOARD, EARLSFORT CENTRE, EARLSFORT TERRACE, DUBLIN 2 TEL: 01 676 4971 FAX: 01 676, Staff Appointments 2 Human Medicines Legislation and Guidelines 2 Notice to holders of Product, Clinical Trials 5 Electronic ADR Reporting 6 Homeopathic Medicines 6 Veterinary Medicines Veterinary Pharmacovigilance Issues 7 New CVMP Representatives 7 Availability of Veterinary Medicines, Ireland’s presidency of EU meetings in the areas of medicines and med- ical devices began on 12
Guide to Clinical Trial Applications
medicines with any type of active substance, including herbal and homeopathic products. Authorised, , Iceland and Liechtenstein) EMA European Medicines Agency EPA Environmental Protection Agency EU, practice GMP Good manufacturing practice HMA Heads of Medicines Agencies HPRA Health Products, Q&A document on the Heads of Medicines Agency (HMA) website. If any product used in the trial, of ICSRs and SUSARs Associated with the Use of Human Medicines’. HPRA Guide to Clinical Trial
Guide to Good Distribution Practice of Medicinal Products for Human Use
import registration EEA European Economic Area EMA European Medicines Agency EMP Exempt, prescription-only medicine, traditional herbal medicinal product, controlled drug , etc.), along, . The national repository system is managed by the Irish Medicines Verification Organisation (IMVO, , pharmacies and hospitals should scan medicines bearing the safety features and if an alert or any
Recall of Medicinal Products for Human and Veterinary Use
authorised products) rests with the European Medicines Agency (EMA), and HPRA liaises with the EMA, is a specific requirement for veterinary medicines under the Animal Remedies Regulations, 2007(SI, Medicines’, for details.) The decision by the EU/PA/VPA/PPA holder or manufacturer that a recall, of Agriculture and Food (Veterinary Medicines Section of the Animal Health &Welfare Division). When, , along with office and mobile telephone numbers, are available in the Medicines section of HPRA’s