SUKL Bulletin 4/2006

Contents of SUKL Bulletin 4/2006  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of March 2006
  • Pharmacy activities
    • Control of pharmacies in the year 2005 Out of the total number of 2.849 samples taken from pharmacies 12 % of samples were found to be non-compliant. The number of non-compliant samples from pharmacies continues to be       relatively high, but since 2004 the quality of medicinal products and purified water prepared in pharmacies has slightly improved.
  • Information
    • Information on controls made in healthcare facilities Controls were focused on treatment with medicinal products and were conducted as initial ones.
    • Information on seminars held by SUKL in the 1st half of 2006 - 1st part The programme of seminars and the application form are included.
    • Outline of notifications on the use of non-authorised medicinal products in the month of March 2006 The information on evaluated notifications in the month of March 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 March 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 February 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.
    • List of new pharmacies and separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the first quarter of 2006
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of March 2006
    • List of medicinal products whose marketing authorisation will expire in June 2006 The validity of marketing authorizations of the listed products will expire during June 2006 and the products will be indicated in SUKL database by "Z"       and published in Věstník SÚKL.
    • List of medicinal products with expired validity of the registration decision The listed products are indicated by "Z" in SUKL database as of March 31,       2006.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of February 23, 2006 to March 22, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from March 1, 2006 to March 31, 2006
    • List of specific therapeutic programmes approved during the period of March 1, 2006 to March 31, 2006