SUKL Bulletin 11/2005

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of October 2005
  • SÚKL quidelines
    • Information on revocation of a SUKL guideline REG-71
    • List of guidelines valid as of December 1, 2005
  • Information
    • Information on the implementation of new European pharmaceutical legislation Questions concerning the transition period till the new European pharmaceutical legislation is transposed in the national legislation were discussed with interested parties. Minutes from these meetings as well as Questions and       Answers document are published on the SUKL website.
    • Information of the State Institute for Drug Control on vaccination against influenza
    • Outline of notifications on the use of non-authorised medicinal products in the month of October 2005 The information on evaluated notifications in the month of October 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 October 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 October 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.
    • Overview of data on basic activities of the Branch of Pharmacy and Distribution Control in the third quarter of 2005
    • Overview of data on basic activities of the Inspection Branch in the third quarter of 2005
    • Overview of data on activities of the Medical Devices Branch in the third quarter of 2005
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of October 2005
    • List of medicinal products whose marketing authorisation will expire in January 2006 The validity of marketing authorizations of the listed products will expire during January 2006 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 October 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 September 22, 2005 to October 19, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from October 1, 2005 to October, 31, 2005
    • List of specific therapeutic programmes approved in the period from August 1, 2005 to October 31, 2005