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Procedure from 01-Apr-2007 to 30-Apr-2007 - Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted for: TOVIAZ, Docetaxel, Winthrop, Advagraf, Sebivo - Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted for: Dynepo, Prevenar, Xigris, AZILECT, Enbrel, Cerezyme, Panretin, TARGRETIN, Infanrix Penta, Infanrix ... (Abstract truncated to see more please, go to the document!) FRANCE France - AFSSAPS: List of Authorized Inspectors This document provides the updated list of the authorized inspectors from the French Agency for the Safety of Health Products (AFSSAPS). Last update: 15-May-2007 (B.O. n° 2007/4) GERMANY Germany - BfArM and PEI Joint Draft Recommendations on Planning, Conduction and Assessment of Observational Studies, Version of 09-May-2007 These draft recommendations jointly published by BfArM and PEI intend to define the terms Observational Study or Non Interventional Study taking into account both german and international considerations. They also give recommendations to the following: - the content of an observational / non interventional study plan, - the study design, - possible ... (Abstract truncated to see more please, go to the document!) Germany - BfArM: Desmopressin Nasal Spray and Risk of Hyponatraemia and Water Intoxication; Removal Of the Indication "Primary Nocturnal Enuresis" (PNE)- Status: 24-May-2007 The CHMP has decided the removal of the indication primary nocturnal enuresis for nasal spray formulations of Desmopressin. Reason for this decision is a higher occurrence of serious adverse drug reactions (hyponatraemia, water intoxication) related to the nasal spray form in comparison to other pharmaceutical forms, which have been reported by a ... (Abstract truncated to see more please, go to the document!) Germany - BfArM Letter: Protection from Drug Risks, Hearing - Stage II - Delayedrelease Oxycodone - 23-May-2007 The BfArM has set 01-Jul-2007 as a deadline for manufacturers to add information on simultaneous intake of ethanol and oxycodone in sections 4.2 “Posology and method of administration” (SPC and Package Leaflet) and 4.4 “Special warnings and precautions for use” (SPC) of the product information of delayed-release oxycodone-containing medicinal products ... (Abstract truncated to see more please, go to the document!) Germany - BfArM Press Release 12/2007: BfArM Warns About Counterfeit TAMIFLU Sold Through Internet - 15-May-2007 BfArM warns patients and consumers about potential risks of buying and taking Tamiflu sold through the internet. Two recent cases of counterfeit have been reported. The two fake medicinal products have been confiscated in South Korea, of which one had been bought through the internet. After analyses, it appears that one of these products contains ... (Abstract truncated to see more please, go to the document!) INTERNATIONAL International - ICH Guideline: Pharmaceutical Quality System (Topic Q 10, Step 2, 09-May-2007) This guideline has been released for consultation on 09-May-2007 at Step 2 of the ICH Process by the ICH Steering Committee. This document establishes a new ICH tripartite
guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. ICH Q10 describes one ... (Abstract truncated to see more please, go to the document!) ITALY Italy - AIFA Pharmacovigilance Bulletin (Reazioni) N. 3/2007 (May-2007) This document concerns the Pharmacovigilance Bulletin (Reazioni) Anno I - N. 3/2007 issued by the AIFA. JAPAN Japan - HPB Notification No. 0515003: Handling of Listing of Generic Medicinal Products to the NHI Drug Price Standard, 15-May-2007 (English/Japanese version) The twice-a-year listing of generic medicinal products to the NHI Drug Price Standard was agreed in the general meeting of the Central Social Insurance Medical Council held on 18th April 2007. Based on this, the timing of listing of generic medicinal products and other products in 2007 and other related matters are decided accordingly. The timing ... (Abstract truncated to see more please, go to the document!) Japan - PFSB/CND Notification No. 0516005: Handling of Overseas Manufacturing Businesses While They are Regarded as Having Accreditations, 16-May-2007 (English/Japanese version) This notification concerns the document to be submitted by importers when they are examined to see if they have submitted the necessary information in accordance with Article 94 and Article 95 of the Pharmaceutical Affairs Law Enforcement Regulations. If a person who imports a product from a business which is regarded as having received the accreditation ... (Abstract truncated to see more please, go to the document!) Japan - PFSB/ELD, PFSB/CND Notice: Schedules for Approval Reviews and GMP Conformity Inspection Applications for Ethical Generic Medicinal Products Which Have Been Submitted for New Marketing Approvals, 15-May-2007 (English/Japanese version) November has been added as an opportunity for listing generic medicinal products and other products to the NHI Drug Price Standard. Consequently MHLW re-scheduled approval reviews, GMP conformity inspections of ethical generic medicinal products for which new marketing approval applications have been filed before the end of July, 2006. Schedules ... (Abstract truncated to see more please, go to the document!) Japan - Q&A: PFSB/ELD, PFSB/CND Notice: Procedure of Change of Manufacturing Site for the Medical Devices and In-vitro Diagnostic Products, 27-Apr-2007 (English/Japanese version) This document presents the Q&A on Procedure of Change of Manufacturing Site for the Medical Devices and In-vitro Diagnostic Products which was issued by PFSB/ELD Notification No. 0330004, PFSB/CND Notification No. 0330012 on 30-Mar-2007 (64982). POLAND Poland - Law 07.75.492 of 30-Mar-2007: Amendment of the Pharmaceutical Law and Amendment of Certain Other Laws This law amends the pharmaceutical law significantly. The changes are far reaching and pertain to clinical trials, registration, manufacture, advertising, wholesale and retail trade, inspections and sanctions.
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