SUKL Bulletin 5/2005

Contents of SUKL Bulletin 5/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of April 2005
  • SÚKL quidelines
    • List of guidelines valid as of June 1, 2005
    • REG-81-Authorisation of medicinal gases The guideline provides information on conditions under which medicinal gases should be authorised as medicinal       products including references to relevant pharmaceutical legislation and       guidelines.
    • DIS-13-Reporting of deliveries of distributed medicinal products The provision       defines more exactly the way of reporting deliveries of medicinal products from wholesalers or manufacturers to health care facilities or vendors of selected medicinal products and the structure of the report.
  • Information
    • Physicians and information on drugs - the survey made in the year 2004 Selected physicians were asked about sources of information on medicinal products which they use. Some questions were asked with the aim to evaluate the impact of advertising activities of pharmaceutical industry on physicians and their information on prescribed drugs.
    • Information on training of users of EudraVigilance system
    • Outline of notifications on the use of non-registered medicinal products in the month of April 2005 The information on evaluated notifications in the month of April 2005, in particular numbers of notifications, patients, health care facilities and used medicinal products is published.
    • 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 April 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.
    • Overview of data on basic activities of the Branch of Pharmacy and Distribution Control in the first quarter of 2005
    • Overview of data on basic activities of the Inspection Branch in the first quarter of 2005
    • Overview of data on activities of the Medical Devices Branch in the first quarter of 2005
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of April 2005
    • List of medicinal products whose marketing authorisation will expire in July 2005 The validity of marketing authorizations of the listed products will expire during July 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 April 30, 2005.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of March 24, 2005 to April 20, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from April 1, 2005 to April, 30, 2005
    • List of specific therapeutic programmes approved during the period of April 1, 2005 to April 30, 2005