PDF-European Medicines Agency Postauthorisation Evaluation

4420 74 18 84 00 Fax 4420 75 23 70 51 Email mailemeaeuropaeu httpwwwemeaeuropaeu European Medicines Agency 2008 Reproduction is authorised provided the source is acknowledged London 5 June 2008 Doc RefEMEAHMPC5135802006 ASSESSMENT REPORT RHAMNUS PU. 4420 74 18 84 00 Fax 4420 74 18 84 09 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2008 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 11 December 2007 CPMP . The inspection of GVK that led to the CHMP’s recommendation was carried out by the French medicines agency (ANSM). The inspectionrevealed data manipulations of electrocardiograms (ECGs) durin (CHMP) GUIDELINE ONTHE CHOICE OF THE NON-INFERIORITY MARGIN DRAFT AGREED BY THE EFFICACY WORKING PARTY ADOPTION BY COMMITTEE FOR RELEASE FOR CONSULTATION February 2004 AGREED BY WORKING PARTY June (CHMP) SEALANT/HAEMOSTATIC PRODUCTS (CPMP/BPWG/153/00) DISCUSSION IN THE BLOOD PRODUCTS WORKING GROUP DISCUSSION IN THE PHARMACOVIGILANCE WORKING PARTY April 2001 TRANSMISSION TO THE CPMP Decembe The majority of international regulatory authorities are obliged by law to have systems in place to verify As an initial effort to improve international sharing of information and to facilitate more Joint Audit Programme for EEA GMP Inspectorates 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: gmp@emea.europa.eu http://www.emea. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) GUIDELINE ON DECLARATION OF HERBAL SUBSTANCES AND HERBAL PREPARATIONS IN HERBAL MEDIC Joint Audit Programme for EEA GMP Inspectorates 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 E-mail: gmp@emea.europa.eu http://www.emea. Harmonization and . African Medicines Agency. Margareth Ndomondo-Sigonda. NEPAD . Planning and Coordinating Agency. Midrand, Johannesburg. South Africa. OUTLINE. Introduction to NEPAD. Background and Overview of the African . Feda?kov Once . the protection of the product . expires for . example, patents or regulatory protection such as data . exclusivity, . the company no longer has exclusive rights to sell the medicine. . Other . The . HDA (formerly BAPW) . Who we are. Good Distribution Practice . HDA is a UK-wide representative trade association whose mission is to advance the interests and values of those member companies who provide . (CHMP) GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR HORMONE REPLACEMENT THERAPY OF OESTROGEN DEFICIENCY SYMPTOMS IN POSTMENOPAUSAL WOMEN DRAFT AGREED BY THE EFFICACY WORKING PARTY Basic enquiry answering. September . 2016. Session aims. Increase awareness of the Medicines Information (MI) services. UK. Wales. Increase awareness of the questions to ask an enquirer. Have practical experience using some resources which will be...