SUKL Bulletin 2/2005

Contents of SUKL Bulletin 2/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of January 2005
  • SÚKL quidelines
    • List of guidelines valid as of March 1, 2005
    • KLH-21-Reporting of suspected unexpected serious adverse reactions of medicinal products for human use in clinical trials The guidance KLH-21 is based on the the relevant national and European legislation and other related guidance documents. It describes reporting responsibilies of the sponsor towards the State Institute for Drug Control, ethics committees and investigators.
    • PHV-3-Non-Interventional Post-Authorisation Safety Studies with Prescription-Only Medicinal Products for Human Use This guideline sets out terms and conditions for conducting of non-interventional post-authorization safety studies with prescription-only medicinal products for human use that are partly       or fully sponsored by pharmaceutical industry or by organizations or persons supported by pharmaceutical industry. The guideline also establishes the public register of these studies and is coming into force on 1st March 2005.
  • Information
    • Information on seminars held by SUKL in the 1st half of 2005 - 2 nd part The programme of seminars and the application form are included.
    • Outline of notifications on the use of non-registered medicinal products in the month of January 2005 The information on evaluated notifications in the month of January 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 January 2005
    • Information on documents issued by the European Medicines Agency (EMEA) A list of new documents issued by the EMEA in December 2004 and January 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.
    • Quarterly evaluation of pharmacies activity Results of the inspection activities of SUKL in pharmacies during the fourth quarter of 2004 are published.
    • Overview of data on basic activities of the Inspection Branch in the fourth quarter of 2004 Data on numbers of various types of inspection activities including times are published.
    • Outline of data on activities of the Medical Devices Branch in the fourth quarter of 2004
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of January 2005
    • List of medicinal products whose marketing authorisation will expire in April 2005 The validity of marketing authorizations of the listed products will expire during April 2005 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 January 31, 2005.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of December 30, 2004 to January 26, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from December 30, 2004 to January 26, 2005
    • List of specific therapeutic programmes approved during the period of December 30, 2004 to January 26, 2005.