SUKL Bulletin 11/2006

Contents of SUKL Bulletin 11/2006  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of October 2006
  • Information
    • Information on lists of pharmacies on the SUKL website
    • Change in the list of test facilities included in the national GLP programme in the field of medicinal products
    • Outline of notifications on the use of non-authorised medicinal products in the month of October 2006 The information on evaluated notifications in the month of October 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 October 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 September 2006 is published. Documents are available in SUKL
    • 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 2006
    • Overview of data on basic activities of the Inspection Branch in the third quarter of 2006
    • Overview of data on activities of the Medical Devices Branch in the third quarter of 2006
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of October 2006
    • List of medicinal products whose marketing authorisation will expire in January 2007 The validity of marketing authorizations of the listed products will expire during January 2007 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 October 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 September 21, 2006 to October 25, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from October 1, 2006 to October 31, 2006
    • List of specific therapeutic programmes approved during the period of October 1, 2006 to October 31, 2006