SUKL Bulletin 10/2006

Contents of SUKL Bulletin 10/2006  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of September 2006
  • SÚKL guidelines
    • List of guidelines valid as of November 1, 2006
    • DIS-13 Version 1 - Reporting of deliveries of distributed medicinal products The revised provision defines more exactly the way of reporting deliveries of medicinal products from wholesalers or manufacturers to health care facilities or vendors of selected medicinal products and the structure of the report.
  • Information
    • Information on seminars held by SUKL in the 2nd half of 2006 The overview of seminars and the application form are included.
    • Information for holders of authorisation for manufacture of medicinal products and for holders of authorisation for control laboratories
    • List of pharmacies offering 24-hour emergency service
    • List of dispensaries of medicinal products (pharmacies performing supply of medicinal products only)
    • Outline of notifications on the use of non-authorised medicinal products in the month of September 2006 The information on evaluated notifications in the month of September 2006, 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 September 2006
    • Information on Czech standards relating to medical devices published in the Bulletin of the COSMT
    • Data on applications submitted to SUKL Data on numbers of various types of applications submitted monthly to SUKL.
    • List of new pharmacies and detached departments for dispensing pharmaceuticals and medical devices approved by SUKL in the third quarter of 2006
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of September 2006
    • List of medicinal products whose marketing authorisation will expire in December 2006 The validity of marketing authorizations of the listed products will expire during December 2006 and the products will be indicated 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 September 30, 2006.
  • Information on registered drugs and and approved specific therapeutic programmes Authorised medicinal products and variations to marketing authorisations approved in       the period from August 24, 2006 to September 20, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from September 1, 2006 to September 30, 2006
    • List of specific therapeutic programmes approved during the period of September 1, 2006 to September 30, 2006