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Displaying 81 - 90 of 113 results.
Annual Report 2020
Preparing for Brexit 15 Human Medicines 18 Medical Devices 26 Blood, Tissues and Organs 31 Veterinary Medicines 33 Scientific Animal Protection 36 Controlled Drugs and Precursor Chemicals 38, The number of EMA scientific advice procedures for human medicines co-ordinated by the HPRA medical, 1 83 MRP/DCP lead member state roles for the assessment of veterinary medicines 10 applications issued for clinical trials of human medicines 73 new human medicines authorised during
HPRA Annual Report 2014
2014 2014 Statistics at a Glance THE TOTAL NUMBER OF NEW HUMAN MEDICINES AUTHORISED NEW MEDICINES FOR VETERINARY USE AUTHORISED THE NUMBER OF INDIVIDUAL AUTHORISATIONS ISSUED UNDER, INTERNATIONAL DRUG MONITORING PROGRAMME NEW PRODUCTS CONSIDERED BY THE INTERNAL HUMAN MEDICINES, FOR HUMAN MEDICINES AUTHORISED THROUGH THE NATIONAL OR MUTUAL RECOGNITION PROCEDURES HPRA RANK IN EU, TO COMMENCE IN IRELAND ON MEDICINES FOR HUMAN USE INFORMATION DAYS AND SEMINARS ORGANISED
HPRA Drug Safety Newsletter Edition 82
Medicines Agency (EMA) has restricted the initiation of daclizum- ab (Zinbryta) and recommends, products and herbal supplements. Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, www.hpra.ie The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency, , contact details below. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment
Guide for National Scientific and Regulatory Advice
and/or the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). Advice, areas: - chemical drug substances and medicinal products, including herbal products, is generally sought by pharmaceutical companies for national and decentralised medicines and by academic, to the method of sale and supply of authorised medicines - proposed labelling for product ranges
Annual Report 2022
2021-2025 – Key achievements in 2022 12 Human Medicines 13 Medical Devices 23 Blood, Tissues and Organs 28 Veterinary Medicines 29 Scientifc Animal Protection 33 Controlled Drugs and Precursor, scientifc advice procedures for human medicines co-ordinated by the HPRA 109 centrally authorised, applications issued for clinical trials of human medicines under the EU Clinical Trials Directive and three authorisations under the new EU Clinical Trials Regulation 64 new human medicines
Annual Report 2013
Annual Report 2013,  Irish Medicines Board Bord Leigheasra na hÉireann Kevin O’Malley House, To protect and enhance public and animal health through the regulation of medicines, medical devices, ENFORCEMENT CASES RESULTING FROM THE ILLEGAL MANUFACTURE, SUPPLY AND SALE OF MEDICINES OR MEDICAL, FOR HUMAN AND VETERINARY MEDICINES 388 NEW NOTIFICATIONS TO THE IMB MEDICAL DEVICES REGISTER, FOR HUMAN MEDICINES RECEIVED 144 NEW VETERINARY MEDICINE APPLICATIONS ASSESSED 289 NATIONAL
IMB Newsletter-Issue No. 18-May-August 2004
Reports 5 Homeopathic Medicines 5 Herbal Medicines 5 Veterinary Medicines Legislation and Guidelines 6, MEDICINES BOARD, EARLSFORT CENTRE, EARLSFORT TERRACE, DUBLIN 2 TEL: 01 676 4971 FAX: 01 676 7836, . Readers will be aware that the revised medicines legislation package was agreed towards the end, with a meeting of the Competent Authorities for Medical Devices. The heads of the various medicines, 2 Human Medicines Legislation and Guidelines 3 Renewals 3 Implementation of Variation Changes
Public consultation on human medicines fees 2021
Public consultation on human medicines fees 2021,  01 OCTOBER 2020 Public Consultation on Annual Review and Proposal for Fees – Financial Year 2021 Human Medicines, Compliance Activities, for fees for financial year 2021 – human medicines, compliance activities, blood, tissue, on annual review of and proposal for fees for financial year 2021 – human medicines, compliance, of human medicines authorisation, manufacturer and wholesaler operations without recourse
IMB Newsletter-Issue No. 26-January-April 2007
Changes 1 New Staff Appointments in the Veterinary Medicines Department 2 Human Medicines Legislation and Guidelines 2 Update on Draft Medicines Regulations 2 Update on Implementation of Traditional Herbal Medicinal Products Directive (2004/24/EC) 2 Homeopathic Medicines: Legislative, of Manufacturing Sites on Product Authorisations 3 Veterinary Medicines Legislation and Guidelines 4 Change to the National Legislation Underpinning IMB Authorisation of Veterinary Medicines 4