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Cannabis for Medical Use - A Scientific Review
1 2 OVERVIEW OF HPRA REVIEW 2 3 BACKGROUND 6 4 MEDICINES AUTHORISATION IN IRELAND 7 5, MEDICINES AUTHORISATION IN IRELAND 29 APPENDIX 4 MISUSE OF DRUGS FRAMEWORK RELATING TO CANNABIS 31, , they are not capable of being authorised as medicinal products (medicines). There appears, proposal to circumvent the medicines regulatory system, established by law, would require careful, ) cannabis-based medicines where the safety, efficacy and quality can be assured, and understood
Annual Report 2019
herbal medicinal products under the simplifed registration scheme 4 4 2 Homeopathic medicines under, Human Medicines 16 Medical Devices 24 Blood, Tissues and Organs 29 Veterinary Medicines 31, in place at year end – 135 for human medicines and 24 for veterinary medicines 1 59 delegates, transfers to Ireland for human and veterinary medicines in advance of Brexit 554 new human medicines authorised during 2019 applications issued for clinical trials of human medicines 433 88
Federal Commission for Protection from Sanitary Risk - Mexico - 2011 MoU with COFEPRIS
and the Irish Medicines Board of Ireland CONCERNING COOPERATION IN THE REGULATION OF THERAPEUTIC, (COFEPRIS) and The Irish Medicines Board (1MB) of Ireland (hereinafter referred as the "Participants, of the same Act, as amended from time to time; and b. medicinal products, herbal medicinal, to or connected with the functions of the 1MB as described in Section 4 of the Irish Medicines, in Sydney on this 26 day of October, 2011 by the Representative oftht?Irish Medicines Board
Guide to Information held by the HPRA
Medicines Performance Evaluation Committee Herbal Medicines Subcommittee Human, medicines and devices for the benefit of people and animals. Our vision is excellence in health product, they are intended to do. Formerly known as the Irish Medicines Board (IMB), we became the HPRA in July 2014, of years to include: - Human medicines - Veterinary medicines - Clinical trials - Medical, for transplantation 3.3 Functions The functions of the HPRA are set out in the Irish Medicines Board Acts
Annual Report 2017
Statement 4 Authority Members 6 Management Committee 7 Chief Executive’s Report 8 Human Medicines 12 Medical Devices 20 Blood, Tissues and Organs 25 Veterinary Medicines 27 Scientific Animal, – 1,486 CERTIFICATES FOR MEDICINES AND 2,371 FREE SALE CERTIFICATES FOR MEDICAL DEVICES 3,857 OUR ASSESSMENT RATING OUT OF 5 UNDER BEMA, THE BENCHMARKING PROGRAMME FOR EUROPEAN MEDICINES AGENCIES 4.5 THE TOTAL NUMBER OF NEW HUMAN MEDICINES AUTHORISED 684 THE NUMBER OF PATIENTS WHO
Strategic Plan 2016 - 2020 English
for clinical trials and herbal medicines. We are part of a European network of regulatory agencies, products available in Ireland: o Human and veterinary medicines o Medical devices for human use, Controlled substances o Cosmetics - Other areas include clinical trials using human medicines, clinical field trials using veterinary medicines and clinical investigations using medical devices, , distribute and market medicines after a review of their safety, quality and effectiveness
Guide to Applications for a New Manufacturer's Authorisation
published by the European Medicines Agency on behalf of the European Commission. The Union Format, carries out processing steps in relation to herbal or homoeopathic dosage forms (e.g. tablets, to herbal or homoeopathic products then include a clarifying remark (‘herbal products only, on the manufacturer’s authorisation. 1.4.1 Manufacture of other products Herbal products, to an authorised human medicines manufacturer’s authorisation. - Justification should be provided
Annual Report 2006 IMB
Annual Report 2006 IMB,  Irish Medicines Board Annual Report 2006  CONTENTS Chairman’s Statement 2 Board Members 4 Organisational Chart 5 Chief Executive’s Report 6 Human Medicines 12 Veterinary Medicines 17 Medical Devices 20 Compliance 24 Information Technology and Change, perspective is fundamental to the monitoring of safety issues across some 6,000 human medicines, 1,200 veterinary medicines and 500,000 medical devices. The IMB actively participates in a wide
IMB Newsletter-Issue No. 15-May-August 2003
of the clinical trials directive 4 Herbal Medicines Project 4 Homeopathic Medicines Project 4 Veterinary Medicines Legislation and Guidelines 4 Changes to EU veterinary medicines legislation 4, Herbal Med- icines Project report and on the report on the IMB Herbal Medicines Seminar held, IMB Newsletter-Issue No. 15-May-August 2003,  E D I C I N E IRISH MEDICINES BOARD, EARLSFORT, increase for 2004 1 Human Medicines Legislation and Guidelines 1 New Variation Regulations 2 Change
Annual Report 2007 IMB
E C T I N G P U B L I C A N D A N I M A L H E A L T H IRISH MEDICINES BOARD ANNUAL REPORT 2007 PROTECTING PUBLIC AND ANIMAL HEALTH Irish Medicines Board Annual Report, Executive’s Report 6 Human Medicines 13 Veterinary Medicines 20 Medical Devices 24, and Committees 70 Appendix II: Glossary 72 Irish Medicines Board Annual Report 2007  ChaIrMaN’S, for the Irish Medicines Board (IMB) in relation to the organisation’s primary objective of safeguarding