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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
Previous Consultations
for fees Human and veterinary medicines and compliance 2021 2020 2019 2018 Medical devices 2020 2018 Human and veterinary medicines, medical devices and compliance 2021 2020 2017, -stakeholder approach to handling medicines shortages (2018) View framework document EU legislation, Devices Distributor Guidance. Guide for retail sale of herbal medicinal products The HPRA undertook a public consultation on the Guide for Retail Sale of Herbal Medicinal Products
Advisory Committees
Committee for Human Medicines: • Clinical Trials Sub-Committee • Herbal Medicines Sub-Committee, 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, members and by pending business. The Clinical Trials Sub-Committee meets each month. The Herbal Sub, Medicines Dr Diarmuid Quinlan – Chair Prof. Brian Cleary Prof. Desmond Corrigan Dr Paul
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, , European Union, Safety & Quality, Medicines, Medical Devices, Blood, Tissues & Cells, Cosmetics
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 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