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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
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of Marketing Status of Human Medicines’. 2 INTRODUCTION Withdrawal, for Human Medicines AUT-G0020-4 2/2 When the PA is withdrawn for commercial reasons, no further batches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
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
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
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