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SUKL Bulletin 9/2007

Contents of SUKL Bulletin 9/2007  


  • Contents
  • Front page news
    • Measures taken in the case of quality defects or adverse reactions to medicinal products in the month of August 2007
  • SÚKL guidelines
    • List of guidelines valid as of October 1, 2007
    • REG-53 version 1 - Requirements for electronic submission of registration dossier Besides the submission of hard copies (i.e. paper copies) of the dossier, the submission of partial or complete copies using electronic storage media - a suitable PC-compatible medium - is encouraged by the State Institute for Drug Control. This document provides applicants with specific requirements, e.g. format, number of copies of dossier.
  • Information on drug consumption
    • Team of authors: Drug consumption in the Czech Republic in the 2nd quarter of the year 2007 Comparison with the situation in the previous period is given.       Figures are expressed in number of packages, Czech crowns and Defined Daily Doses.
  • Information
    • Close of Twinning project The twinning project aimed at strengthening of the Institute's expert capacity in regulation of medical devices and human tissues and cells and in assessment of marketing authorisation dossiers was       successfully completed in July 2007. The British regulatory agency MHRA in partnership with French AFSSAPS provided training and expert advice to SUKL staff. More than 150 expert days were delivered within 12 months of the project which was fully financed by the European Commision.
    • Outline of notifications on the use of non-authorised medicinal products in the month of August 2007 The information on evaluated notifications in the month of August 2007, in particular numbers of notifications, patients, health care facilities and used medicinal products is published.
    • List of authorised medicinal products where placing on the market of individual batches with the labelling in a foreign language was approved in the month of August 2007
    • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
    • Information on documents issued by the European Medicines Agency (EMEA) A list of new documents issued by the EMEA in July 2007 is published. Documents are available in SUKL library.
    • Data on applications submitted to SUKL Data on numbers of various types of applications submitted monthly to SUKL.
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of August 2007
    • List of medicinal products whose marketing authorisation will expire in November 2007 The validity of marketing authorisations of the listed products will expire during November 2007 and the products will be marked in SUKL database by "Z" and published in Věstník SÚKL.
    • List of medicinal products with expired marketing authorisation The listed       products are marked by "Z" in SUKL database as of August 31, 2007.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from July 26, 20076 to August 22, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from August 1, 2007 to August 31, 2007