Argentina - Drug Information Association

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Product Name: MULTAQ INN: dronedarone Pharmaceutical form: filmed tablet Used for treatment: of adult clinically stable patients with a history or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. Marketing Authorization Holder: Sanofi Aventis The Federal Office for Health Care Safety wishes to inform about risk of severe liver injury associated with the use of MULTAQ and necessary monitoring of patients receiving MULTAQ. Cases of liver injury, including two cases of liver failure requiring transplantation have been reported in patients receiving dronedarone. Some of these cases occurred early after start of treatment. As a precaution, patients receiving dronedarone should have their liver function monitored prior to treatment; then on a monthly basis for 6 months; at months 9 and 12 and periodically thereafter. Sections 4.4 and 4.8 of the Summary of Product Characteristics (SmPC) will be updated accordingly. Document date: 25-Jan-2011 Type of text: BASG Safety Information Regulatory version: None Language: German Austria - Federal Office For Health Care Safety (BASG): Safety Information of 31- Jan-2011 on OPTIMARK and Nephrogenic Systemic Fibrosis (NSF) Product Name: OPTIMARK INN: gadoversetamide Pharmaceutical Form: solution for injection Used for treatment: indicated for diagnostic use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology. Marketing Authorization Holder: Covidien The Federal Office for Health Care Safety wishes to inform about risk of nephrogenic systemic fibrosis (NSF) associated with OPTIMARK (gadoversetamide) and prescribing information (contraindication, precautions for use). Document date: 31-Jan-2011 Type of text: BASG Safety Information Regulatory version: None Language: German Austria - Federal Office for Health Care Safety Form: to Obtain a Manufacturing Licence - 13-Jan-2011 This form is available in a ready-to-use format. This is the form to be used to obtain a manufacturing licence for medicinal products according to sections 63 and 65 of the Austrian Drug Law and to submit together with "Federal Office for Health Care Safety Form: Documents to Submit for Obtaining an Operating Licence: Basis Documentation" (86170). An explanation sheet regarding this form is available. Please refer to 39475. Additional information shall be appended to this application form depending on the kind of licence which is applied for: - Manufacturing of finished medicinal products (106643); - Wholesale, office only (without manufacturing site) (106630); - Secondary packaging (106644). For more information related to this topic, please refer to "Marketing Authorization Procedures: Procedure for Applying for a Manufacturing / Wholesale Licence" (104892). Document date: 13-Jan-2011 Type of text: Form Regulatory version: None Language: German Austria - AGES PharmMed: Scientific Guidance for the Conduct of Non- Interventional Studies (NIS) in Austria – Status: 01-Jan-2011 (German & English Versions) This document aims at providing guidance for the planning, notification and conduction of non-interventional studies in Austria. It is not legally binding. It covers the following topics: 1. Definitions and legal framework 2. Distinction from clinical trial 3. Patient information and Informed Consent 4. Consultation of an Ethics Committee 5. Reimbursement and remuneration 6. Data collection and ADR reporting 7. Potential objectives of NIS 8. Observation and evaluation plan 9. Documentation regarding treatment 10. Final report and abridged final report 11. Substantial amendments 12. References (extract) Comment: This document replaces "AGES PharmMed: Draft Scientific Guidance on the Conduct of Non-Interventional Studies (NIS) in Austria – 30-Apr-2010" (109891). Document date: 01-Jan-2011 Type of text: Other texts Regulatory version: Final Language: Multilingual Brazil Brazil - ANVISA Information Note: Sound Partnership Enhances Medicinal Products' Quality in MERCOSUR, 03-Feb-2011
MERCOSUR highlights ANVISA plays a crucial role in the development of this international partnership. ANVISA has worked hard on Pharmacopoeia, medicines, food, fight against counterfeit, frontier control, new technology, blood products etc. So far, MERCOSUR member states (Argentina, Brazil, Paraguay and Uruguay) have developed the Good Manufacturing Practices of blood products and have worked hard on bioavailability and bioequivalence matters to standardise marketing authorisation procedures and guarantee medicines’ safety and efficacy in the region. Furthermore, MERCOSUR is looking into creating a regional pharmacopoeia and therefore, Uruguay and Paraguay are developing reference chemical substances (Substâncias Químicas de Referência, SQR) and monographies. This initiative had already been started by Argentina and Brazil. The health agencies of these countries, ANMAT and ANVISA, have been exchanging expertise and knowledge on reference chemical substances. The regional pharmacopoeia project aims to reduce the reliance on imports of reference substances from foreign pharmacopoeias and to foster technology and science development. Document date: 03-Feb-2011 Type of text: Information note Regulatory version: None Language: Portuguese Brazil - Resolution RDC 02: Sets Forth Provisions on the Assessment of Marketing Authorisation & Post-registration Applications of Medicinal Products Developed under Public-Private & Public-Public Partnerships, 02-Feb-2011 ANVISA sets up technical committees (Comitês Tecnicos Regulatorios, CTR) to assess the marketing authorisation (MA) applications' and post-registration procedures of medicinal products under agreements signed by the Ministry of Health. These committees shall be made up by ANVISA representatives. However, if one of the parties executing the agreement were a foreign body, ANVISA shall be empowered to appoint foreign authorities members of the committee. Applicants shall submit the MA dossier and post-registration applications with all the documents set forth in the effective regulation. Postregistration applicants shall submit applications with all the relevant documents according to effective regulation. The application stages and the documents to submit are thoroughly described in the annex attached to the resolution. ANVISA shall assess these applications. The health agency can require additional documents on MA or post-registration processes, if necessary and is also empowered to inspect manufacturing sites, centres conducting pharmaceutical equivalence bioequivalence studies. Comment: This document repeals Resolution RDC 47: Set Provisions for the Procedures and Follow up of Medicinal Products Registration and Post-registration in Brazil Manufactured by Partnerships between Government Companies and by Government and Private Companies with Technology Transfer, 04-Nov-2010 (116056). Document date: 02-Feb-2011 Type of text: Resolution Regulatory version: None Language: Portuguese Canada Canada - How to Market Medical Devices This IDRAC explanatory document relates to medical devices. It provides definition of medical devices, explains the legal framework, outlines the requirement for registration and the format and content of the application. This document also provides details about fees, clinical research, labeling, post-marketing requirements, advertising and pricing and reimbursement. Document date: Jan-2011 Type of text: Explanatory Language: English Canada - Guidelines: for Temperature Control of Drug Products during Storage & Transportation (GUI-0069), 28-Jan-2011 These guidelines are intended to be applicable to all persons and companies involved in the storage and transportation of drug products. All persons and companies including fabricators, packagers/labellers, testers distributors, importers, and wholesalers have the responsibility for ensuring that appropriate storage and transportation conditions are maintained from the point of manufacturing up to the delivery of the drug products to the final distribution point. The maintenance of the chain of storage and transportation conditions should be supported by written agreements among the distributor, the importer, the wholesaler, and the transportation provider in order to preserve drug safety, quality and efficacy. The responsibility of each party, is to ensure that the required storage and transportation conditions are met through their respective GMP activities. These guidelines apply equally to drugs for human and veterinary use and to clinical trial drugs for human use as required under C.05.010(j) and to samples that are distributed to professionals as per Section 14 of the Food and Drugs Act (24022). The present edition of this document includes additional bullets and sub-sections, examples throughout the document, re-wording for greater clarity and an updated reference list. In addition, further modifications were made to GUI-0069 to correspond with changes made to the "Good Manufacturing Practices (GMP) Guidelines, 2009 edition (GUI-0001)" (91881). Comment: This document replaces: - Guide 0069: Guidelines for Temperature Control of Drug Products During Storage and
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Argentina - Drug Information Association

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