SUKL Bulletin 10/2005

Contents of SUKL Bulletin 10/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of September 2005
  • SÚKL quidelines
    • Information on revocation of a SUKL guideline
    • List of guidelines valid as of November 1, 2005
    • DIS-14-Humanitarian aid shipments containing medicinal products Legal requirements for providing medicinal products as humanitarian aid are described. The rules are based on Act no. 79/1997 Coll., on Pharmaceuticals.
  • Information
    • Information on current legislation in the area of medical devices After accession of the Czech Republic to the European Union the legislation in the area of medical devices changed. This information is intended in particular for providers of health care, manufactures and distributors.
    • Outline of notifications on the use of non-authorised medicinal products in the month of September 2005 The information on evaluated notifications in the month of September 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 September 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 September 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 manufacturers and distributors of pharmaceuticals in the CR approved in the month of September 2005
    • List of new pharmacies and detached departments for dispensing pharmaceuticals and medical devices approved by SUKL in the third quarter of 2005
    • List of medicinal products whose marketing authorisation will expire in December 2005 The validity of marketing authorizations of the listed products will expire during December 2005 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 September 30, 2005.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from August 11, 2005 to September 21, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from September 1, 2005 to September, 30, 2005
    • List of specific therapeutic programmes approved by MoH CR - Correction