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Information for the Public THMPs
, including herbal medicines. Like all medicines, THMPs can cause side effects, although, as herbal medicinal products. Even though they are natural, a number of these products may be dangerous, herbal medicinal product (THMP) must: be intended and designed for use without the intervention, , including herbal medicinal products, normally need a marketing authorisation to be placed on the EU, to facilitate the marketing of THMPs in the EU. The Herbal Directive ensures that THMPs purchased
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
Guide to Definition of a Human Medicine
EXAMPLES OF PRODUCT CATEGORIES 9 6.1 Herbal medicines (products containing plant-based medicinal, . 6.1 Herbal medicines (products containing plant-based medicinal ingredients) Herbal medicinal, Medicines Board Act 1995 and 2006. It is also the competent authority for cosmetics. The HPRA, to regulate 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
HPRA Medicinal Products Newsletter - Issue Number 61
Technical Document format for herbal medicinal products Human Medicines Notifcation of marketing, Medicines) • Potential withdrawals arising due to Brexit • Packaging • Request for PA/VPA numbers in advance of an application • Brexit and Clinical Trials for Human Medicines • Type IA Annual, • Safety features Update for manufacturers and Marketing Authorisation Holders Human Medicines • Notifcation of marketing status for traditional herbal medicinal products (THMPs) • Appropriate use
How to take medicines safely
. Tell your doctor and pharmacist about any other medicines that you are taking including herbal, How to take medicines safely, HPRA Website, HPRA Logout How to take medicines safely Medicines can make the quality of our, some conditions from developing in the first place. In this way, medicines can help us live longer and healthier lives. Nearly all of us will need to take medicines at some point in our lives
Homeopathic Medicines
indications and a National Rules Scheme for homeopathics with indications. Homeopathic Medicines are distinct from other types of medicines, such as Herbal Medicines or Pharmaceutical Drugs, although, Homeopathic Medicines, HPRA Website, Logout Homeopathic Medicines Homeopathic medicines must be licensed by the HPRA, in their preparation as well as the principles on which they are prescribed. Preparation of Homeopathic Medicines