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SUKL Bulletin 11/2007

Contents of SUKL Bulletin 11/2007  


  • Contents
  • Front page news
    • Measures taken in the case of quality defects or adverse reactions to medicinal products in the month of October 2007
  • SÚKL guidelines
    • List of guidelines valid as of December 1, 2007
    • UST-29 version 2 - Administration fees and costs reimbursement for activities performed on request, costs reimbursements for activities connected with providing information and costs reimbursements for other activities This revision of the guideline UST-29 version 1 brings changes in payment of costs reimbursement with effect from 1 December 2007. The revised guideline also replaces UST-6 and cancels UST-25 version 1.
  • Information
    • Outline of notifications on the use of non-authorised medicinal products in the month of October 2007 The information on evaluated notifications in the month of October 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 October 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 September 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.
    • Overview of data on basic activities of the Branch of Pharmacy and Distribution Control in the third quarter of 2007
    • Overview of data on asic activities of the Inspection Branch in the third quarter of 2007
    • Overview of data on activities of the Medical Devices Branch in the third quarter of 2007
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of October 2007
    • List of medicinal products whose marketing authorisation will expire in January 2008 The validity of marketing authorisations of the listed products will expire during January 2008 and the products will be marked in SUKL database by "Z" and published in Věstník SÚKL.
    • List of medicinal roducts with expired marketing authorisation The listed       products are marked by "Z" in SUKL database as of October 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 September 27, 2007 to October 24, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from October 1, 2007 to October 31, 2007
    • List of specific therapeutic programmes approved in the period from October 1, 2007 to October 31, 2007