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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 Good Distribution Practice of Medicinal Products for Human Use
import registration EEA European Economic Area EMA European Medicines Agency EMP Exempt, experience of relevance to GDP of medicines. Evidence of six months full-time direct GDP experience, of relevance to GDP of medicines predating their role as a contract RP. When this information is not readily, be documented (e.g. prescription-only medicine, traditional herbal medicinal product, controlled drug, etc, repository system is managed by the Irish Medicines Verification Organisation (IMVO) (www.imvo.ie
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