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Information for the Public THMPs
they are taking, including herbal medicines. Like all medicines, THMPs can cause side effects, are known as herbal medicinal products. Even though they are natural, a number of these products may, . A traditional herbal medicinal product (THMP) must: be intended and designed for use without, Medicinal products, including herbal medicinal products, normally need a marketing authorisation, ) was adopted to facilitate the marketing of THMPs in the EU. The Herbal Directive ensures that THMPs
Advisory Committees
Committee for Human Medicines: • Clinical Trials Sub-Committee • Herbal Medicines Sub-Committee, of reference and rules of procedure of the Clinical Trials Subcommittee Herbal Medicines, Sheridan Dr Emma Wallace Terms of Reference and rules of procedure of the Herbal Medicines, Medicines and the Advisory Committee for Medical Devices are appointed by the Minister for Health while the Advisory Committee for Veterinary Medicines is appointed by the Minister for Health
Medicines Authorisation
Herbal and Homeopathic Medicines Labelling procedure New Product Recent updates to the list of authorised Veterinary Medicines, Medicines Authorisation, HPRA Website, My HPRA Logout Medicines Authorisation This part of our website includes, Union, Safety & Quality, Medicines, Medical Devices, Blood, Tissues & Cells, Cosmetics, Publications
Medicines Authorisation
Batch Specific Requests Herbal Medicines Homeopathic Medicines Legal Supply Status, Medicines Authorisation, HPRA Website, My HPRA Logout Medicines Authorisation This part of our website includes, are considered as medicines, and will therefore need a marketing authorisation from the HPRA. The marketing, for licensing human medicines in Ireland should review the relevant documents, including guides and forms
Homeopathic Medicines
Medicines are distinct from other types of medicines, such as Herbal Medicines or Pharmaceutical Drugs, Homeopathic Medicines, HPRA Website, My HPRA Logout Homeopathic Medicines Homeopathic medicines must be licensed, of Homeopathic Medicines involves the use of minute amounts of substances, which are dissolved, further diluted, medicines must be licensed before being placed on the Irish market in order to fulfil EU and Irish
Guide to Definition of a Human Medicine
EXAMPLES OF PRODUCT CATEGORIES 9 6.1 Herbal medicines (products containing plant-based medicinal, medicines (products containing plant-based medicinal ingredients) Herbal medicinal products, Medicines Board Act 1995 and 2006. It is also the competent authority for cosmetics. The HPRA, herbal medicinal products and updated the special provisions for homeopathic medicinal products, , in order to place the product on the market in Ireland. In the case of herbal medicinal products
HPRA Newsletter Issue 48: May to August 2014
or traditional herbal medicines registration. If there is any uncertainty about whether specifc products, November • GMP Conference 2014 - 12 November Human Medicines • Article on Milk Thistle, Veterinary Medicines • Regulation of clinical trials on Veterinary Medicines in Ireland • Marketing Status / Sunset Clause • Publication of Public Assessment Reports for Veterinary Medicines, Herbal Medicinal Products: Public Consultation. In this Issue General Given that the European
Guide to Withdrawal of Authorisations or Certificates for Veterinary Medicines
Guide to Withdrawal of Authorisations or Certificates for Veterinary Medicines,  AUT-G0039-3 1/2 Guide to Withdrawal of Authorisations or Certificates for Veterinary Medicines 1 SCOPE, of traditional-use registration for a herbal medicinal product. For the withdrawal of a product from the market, please see the ‘Guide to notification of marketing status of veterinary medicines’. 2, . HPRA Withdrawal of Authorisations or Certificates for Veterinary Medicines AUT-G0039-3 2/2 4
HPRA Medicinal Products Newsletter – Issue Number 71 – June 2022
June 2022 HPRA MEDIC INA L PRODUC TS ISSUE 71 NEWSLE TTER Human Medicines • Genotoxic, of (traditional) herbal medicinal products with pyrrolizidine alkaloids • Brexit – products, Medicines • Update on implementation of requirements of Regulation 2019/6 • Article 34 of Regulation 2019/6 • New national legislation on veterinary medicines • Antiparasitic veterinary, In this Issue Human Medicines Genotoxic medicinal products and duration of contraceptive use
HPRA Newsletter Issue 49: September - December 2014
– DECEMBER 2014 HPRA MEDIC INA L PRODUC TS ISSUE 49 NEWSLE TTER General • Herbal Medicines Information Seminar – 14th January Human Medicines • Proactive Approach to Reclassifcation, General The HPRA held an information seminar on herbal medicines on Wednesday 14th January. This was the fourth event on herbal medicines held by the HPRA (formerly Irish Medicines Board, IMB, to registered attendees on our website. Herbal Medicines Information Seminar - 14th January HPRA