SUKL Bulletin 8/2006

Contents of SUKL Bulletin 8/2006  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of July 2006
  • Pharmacopoeia activities
    • Announcement of texts of the Czech Pharmacopoeia being recognized as official standards
    • Announcement of texts of the European Pharmacopoeia being recognized as official standards in the Czech Republic
  • Information
    • Information on forthcoming publications List of pharmacies, manufacturers and wholesalers of medicinal products in the CR and List of OTC medicinal       products and products with narcotic substances will be published.
    • Outline of notifications on the use of non-authorised medicinal products in the month of July 2006 The information on evaluated notifications in the month of July 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 July 2006
    • 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 May and June 2006 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 second quarter of 2006
    • Overview of data on basic activities of the Inspection Branch in the second quarter of 2006
    • Overview of data on activities of the Medical Devices Branch in the second quarter of 2006
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of July 2006
    • List of medicinal products whose marketing authorisation will expire in October 2006 The validity of marketing authorizations of the listed products will expire during October 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 July 31, 2006.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from June 22, 2006 to July 19, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from July 1, 2006 to July 31, 2006
    • List of specific therapeutic programmes approved during the period of July 1, 2006 to July 31, 2006