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Guide to Withdrawal of Authorisations or Certificates for Human Medicines
Guide to Withdrawal of Authorisations or Certificates for Human Medicines,  AUT-G0020-4 1/2 Guide to Withdrawal of Authorisations or Certificates for Human Medicines 1 SCOPE This guide, 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of Marketing Status of Human Medicines’. 2 INTRODUCTION Withdrawal, for Human Medicines AUT-G0020-4 2/2 When the PA is withdrawn for commercial reasons, no further batches
IMB Newsletter-Issue No. 42-May-August 2012
General  Update on herbal medicines 1 Human Medicines  Implementation of the new EU pharmacovigilance legislation: changes to reporting requirements 2 Veterinary Medicines  Staff changes 3, or to be registered under the Traditional Herbal Medicines (THM) scheme provided for by the Directive. From 30, . Those herbal medicines which were subject of applications for THM registration as of the time, No. 42 M E D I C I N A L P R O D U C T S IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE, EARLSFORT
HPRA Medicinal Products Newsletter - Issue Number 55
Human Medicines • Contamination of herbal products with pyrrolizidine alkaloids • Improved Access, on the draft Commission acts on GMP In this Issue Human Medicines Contamination of herbal, the presence of these alkaloids in herbal products, although they do not contain plants that produce, with weeds during harvesting. A public statement on the contamination of herbal medicinal product with pyrrolizidine alkaloids was published by the EMA’s herbal medicinal products committee (HMPC
Electronic submissions
to electronic submissions - human medicines either in eCTD format / non -eCTD (Nees) format or through, Herbal MP Application Homeopathic MP Application Homeopathic National Rules, , Regulatory, Authority, HPRA, Ireland, Eire, European Union, Safety & Quality, Medicines, Medical Devices, , the quality, safety and efficacy of medicines available in Ireland and to participate in systems
HPRA - Press Release - Operation Pangea 2015
used to bulk up the medicines are harmful. People also need to be cautious about buying herbal, OPERATION TARGETING ONLINE FALSIFIED MEDICINES Over 142,000 units of illegal prescription medicines, sale of falsified (counterfeit and illegal) medicines where the HPRA, Revenue’s Customs Service, networks behind the sale of counterfeit and illegal medicines via illicit online sales. Locally, (analgesics), weight loss products as well as anabolic steroids and medicines indicated for erectile
Medsafe New Zealand - 2010 MoU with MedSafe (NZ)
Medsafe New Zealand - 2010 MoU with MedSafe (NZ),  NEW ZEALAND MEDICINES AND MEDICAL DEVICES SAFETY AUTHORITY A BUSINESS UNIT OF THE' MIN IS my OF HEAL TH IRISH MEDICINES BOARD m, and the Irish Medicines Board of Ireland CONCERNING C O O P E R A T I O N IN T H E REGULATION O F, for and on behalf of the New Zealand Medicines and Medical Device Safety Authority (Medsafe) of New Zealand and The Irish Medicines Board (1MB) of Ireland (hereinafter referred as the "Participants
Periodic Safety Update Reports (PSURs)
: Article 10.1 generics Article 10.a well-established use Article 14 homeopathic medicines Article 16a traditional herbal medicines Further information on GVP and the EURD list may be found on the European Medicines Agency website. Please note that the EURD list is a living, is authorised in more than one Member State. The European Medicines Agency maintains a list of EU reference dates and frequency of submission of PSURs (EURD list) for active substances contained in medicines
IMB Newsletter-Issue No. 8-Octomber 2000-March 2001
............................................................................................................... 7 Herbal Medicines Herbal Medicines Project Update, . HERBAL MEDICINES Herbal Medicines Project Update The Herbal Medicines Project first interim report, throughout the Herbal Medicines Table 1. Scientific Committee on Herbal Medicinal Products Member, IMB Newsletter-Issue No. 8-Octomber 2000-March 2001,  IRISH MEDICINES BOARD Bord Leigheasra na h
IMB Newsletter-Issue No. 11-January-April 2002
Herbal Medicines Herbal Medicines Project Update, MEDICINES Herbal Medicines Project Update Herbal Medicines Project Seminar Following submission of final report of the Herbal Medicines Project to the Department of Health and Children in January, The European Medicines Evaluation Agency (EMEA) recently agreed that the Herbal Medicinal Products Working, IMB Newsletter-Issue No. 11-January-April 2002,  IRISH MEDICINES BOARD Bord Leigheasra na