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SUKL Bulletin 4/2007

Contents of SUKL Bulletin 4/2007  


  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of March 2007
  • SÚKL guidelines
    • List of guidelines valid as of May 1, 2007
    • Guidelines and forms for authorization of medicinal products cancelled as of May 1, 2007
    • UST-33 - Application of Act No 477/2001 Coll., as amended, on packages, in relation to pharmaceuticals This guideline reflects the changes in the Act on Packages that were made in compliance with the EU regulations in this area. This amendment to the Act on Packages brings our national legislation in conformity ith the EU legislation. The relevant regulations have been made clearer and less complicated and the act does not put an excess burden on small businesses and legal entities. In the area of medicinal products, the changes apply mainly to labelling.
  • Information
    • Information about change in assigning the identification codes upon issue of the marketing authorization for a medicinal product
    • Information on controls made in healthcare facilities in the year 2006 Controls were focused o treatment with medicinal products and were conducted as initial ones.
    • Outline of notifications on the use of non-authorised medicinal products in the month of March 2007 The information on evaluated notifications in the month of March 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 March 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 February 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.
    • List of new pharmacies and separatedepartments for dispensing pharmaceuticals and medical devices approved by SUKL in the first quarter of 2007
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of March 2007
    • List of medicinal products whose marketing authorisation will expire in June 2007 The validity of marketing authorizations of the listed products will expire during June 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 March 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 Febuary 22, 2007 to March 21, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from March 1, 2007 to March 31, 2007
    • List of specific therapeutic programmes approved in the period of March 30, 2007 to March 31, 2007