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SUKL Bulletin 8/2007

Contents of SUKL Bulletin 8/2007  


  • Contents
  • Front page news
    • Measures taken in the case of quality defects or adverse reactions to medicinal products in the month of July 2007
  • SÚKL guidelines
    • List of guidelines valid as of September 1, 2007
    • KLH-21 version 1 - Reporting of suspected unexpected serious adverse reactions to medicinal products for human use in clinical trials The revision of the guideline describes reporting responsibilies of the sponsor towards the State Institute for Drug Control, ethics committees and investigators. The revision is based on the updated national and European legislation and other related guidance documents.
    • VYR-29 version 1 -  Application for an authorisation/change to authorisation for manufacture of blood components and materials derived from blood and its components for further manufacture New application forms for authorisation for manufacture of blood components and materials derived from blood and its       components for further manufacture and for a change to that authorisation, including annexes as resulted from the amended legislation.
  • Information
    • Information about performed change in assigning the identification codes of SUKL - conversion of codes The codes of SUKL issued for medicinal products with marketing authorization were changed as of July 1, 2007.
    • European workshop of the project RAPSODY - report SUKL hosted the European Workshop on Centres of Expertise and Reference Networks for rare Diseases held in Prague on July 12-13, 2007. This event participated by representatives of patient groups, healthcare professionals and policy makers from all EU Member States was a part of the international project Rare Disease Patient Solidarity (RAPSODY), supported by the European Commission and aimed at improvement of the quality of care, information and social services for rare disease patients.
    • Outline of notifications on the use of non-authorised medicinal products in the month of July 2007 The information on evaluated notifications in the month of July 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 June 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 June 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.
    • Overview of data on basic activities of the Branch of Pharmacy and Distribution Control in the second quarter of 2007
    • Overview of data on basic activities of the Inspection Branch in the second quarter of 2007
    • Overview of data on activities of the Medical Devices Branch in the second quarter of 2007
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of July 2007
    • List of medicinal products whose marketing authorisation will expire in October 2007 The validity of marketing authorisations of the listed products will expire during October 2007 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 marked by "Z" in SUKL database as of July 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 June 21, 20076 to July 25, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from July 1, 2007 to July 31, 2007
    • List of specific therapeutic programmes approved in the period from July 1, 2007 to July 31, 2007