SUKL Bulletin 7/2007

Contents of SUKL Bulletin 7/2007  

 

  • Contents
  • Front page news
    • Measures taken in the case of quality defects or adverse reactions to medicinal products in the month of June 2007
  • SÚKL guidelines
    • List of guidelines valid as of August 1, 2007
    • UST-16 version 1-Sponsorship according to the Act on Advertising According to the amendment to the Act on Advertising (No. 40/1995, Coll.), which came into force on January 26, 2006, sponsorship of promotional meetings and scientific congresses attended by persons qualified to prescribe or supply medicinal products is considered as advertising. SUKL as the authority responsible for monitoring of medicinal products advertising sets up more detailed rules for sponsorship in this guideline.
    • UST-32 version 1 - Reporting and evidence of EAN codes The revision of the guideline newly specifies and explains obligation of the MA holders to label all medicinal products with EAN codes and inform SUKL about EAN codes of their medicinal products. Authorised products not marked with the EAN code or those marked with a code different from that in SUKL records shall be considered defective and appropriate action will be taken.
  • Information
    • Marketing authorization holders invited to send applications for dispensing switch from Rx to OTC The switch of medicinal products mentioned in the table (ATC groups A01 - G01 ) will proceed by simpler way if the application is sent by August 31, 2007.
    • Information on forthcoming publications List of pharmacies, manufacturers and wholesalers of medicinal products in the CR and List of OTC medicinal       products and products with narcotic substances will be published.
    • Information on office hours of the mail room of SUKL in August 2007
    • Outline of notifications on the use of non-authorised medicinal products in the month of June 2007 The information on evaluated notifications in the month of June 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 May 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 separate departments for dispensing pharmaceuticals and medical devices approved by SUKL in the second quarter of 2007
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of June 2007
    • List of medicinal products whose marketing authorisation will expire in September 2007 The validity of marketing authorisations of the listed products will expire during September 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 June 30, 2007.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from May 24, 2007 to June 20, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from June 1, 2007 to June 30, 2007
    • List of specific therapeutic programmes approved in the period from June 1, 2007 to June 30, 2007