SUKL Bulletin 9/2005

Contents of SUKL Bulletin 9/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of August 2005
  • SÚKL quidelines
    • List of guidelines valid as of October 1, 2005
    • UST-32-Reporting and evidence of EAN codes Since January 1, 2004, there is a legal requirement for all medicinal products to be labelled with EAN codes. The MA holders should fulfil this duty and inform SUKL about EAN codes of       their medicinal products. Authorised products without being marked with the EAN code or those marked with a code different from that in SUKL records shall be considered defective and appropriate action will be taken.
  • Information on drug consumption
    • Team of authors: Drug consumption in the Czech Republic in the 2nd quarter of the year 2005 Comparison with the situation in the previous period is given.       Figures are expressed in number of packages, Czech crowns and Defined       Daily Doses.
  • Information
    • Information on seminars held by SUKL in the 2nd half of 2005 - II. part The programme of seminars and the application form are included.
    • Outline of notifications on the use of non-authorised medicinal products in the month of August 2005 The information on evaluated notifications in the month of August 2005, 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 2005
    • 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 August 2005 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 2005
    • List of medicinal products whose marketing authorisation will expire in November 2005 The validity of marketing authorizations of the listed products will expire during November 2005 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 indicated by "Z" in SUKL database as of August 31, 2005.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from July 14, 2005 to August 10, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from August 1, 2005 to August, 31, 2005