SUKL Bulletin 4/2005

Contents of SUKL Bulletin 4/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of March 2005
    • Information on reported adverse incidents of medical devices
  • SÚKL quidelines
    • List of guidelines valid as of May 1, 2005
    • SLP-6-National GLP Programme - Components of Procedures for GLP Monitoring Joint document covering both pharmaceuticals (the GLP Monitoring Authority in the Czech Republic for pharmaceuticals is SUKL) and chemicals (this area is monitored by the National Inspection Authority NIO).
  • Information
    • Experiences from supervision over advertising of medicinal products in 2004 Numbers of investigated cases of reports on breaches of legal regulations were       published together with solutions set up. Information on survey among physicians describing advertising activities of pharmaceutical firms is included.
    • Outline of notifications on the use of non-registered medicinal products in the month of March 2005 The information on evaluated notifications in the month of March 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 March 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 March 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.
    • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the first quarter of 2005
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of March 2005
    • List of medicinal products whose marketing authorisation will expire in June 2005 The validity of marketing authorizations of the listed products will expire during June 2005 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 indicated by "Z" in SUKL database as of March 31, 2005.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of February 24, 2005 to March 23, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from January 27, 2005 to March, 31, 2005
    • List of specific therapeutic programmes approved during the period of March 1, 2005 to March 31, 2005