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SUKL Bulletin 2/2007

Contents of SUKL Bulletin 2/2007  


  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of January 2007
    • Important announcement on the withdrawal of a medical device
  • SÚKL guidelines
    • List of guidelines valid as of March 1, 2007
    • UST-27 version 1-Basic provisions of the Act on Advertising Regulation concerning the advertising of human medicinal products The revision of       the guideline includes conditions relating to advertising in communication media (especially printed and electronic advertisements), their explanation and examples expressing the attitude of SUKL. It is based on the provisions of the Act No. 40/1995 Coll., as amended (the new Act has been valid since January 26, 2006).
    • VYR-28-version 1- Application for an authorisation for activities of control laboratory, change to an authorisation for activities of control laboratory and guidance for provision of detailed information on activities New application forms for an authorisation for activities of control laboratory and for a       change to that authorisation, and guidance for provision of detailed       information on activities including annexes as resulted from the amended       legislation (Compilation of Community procedures on inspections and       exchange of information, July 2006).
  • Information
    • Medicinal products for human use prescribed by veterinary doctors and possible impact of theirprescription on the monitoring of consumption of medicinal products in the Czech Republic
    • Information for members of ethics committees
    • Outline of notifications on the use of non-authorised medicinal products in the month of January 2007 The information on evaluated notifications in the month of January 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 January 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 December 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.
    • Overview of data on basic activities of the Branch of Pharmacy and Distribution Control in the fourth quarter of 2006
    • Overview of data on basic activities of the Inspection Branch in the fourth quarter of 2006
    • Overview of data on activities of the Medical Devices Branch in the fourth quarter of 2006
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of January 2007
    • List of medicinal products whose marketing authorisation will expire in April 2007 The validity of marketing authorizations of the listed products will expire during April 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 January 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 December 21, 2006 to January 24, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from January 1, 2007 to January 31, 2007
    • List of specific therapeutic programmes approved in the period of January 1, 2007 to January 29, 2007