SUKL Bulletin 1/2005

Contents of SUKL Bulletin 1/2005  

 

  • Contents
  • PF 2005
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of December 2004
  • SÚKL quidelines
    • List of guidelines valid as of February 1, 2005
    • REG-80-Inclusion of a medicinal product already authorised in the CR into Mutual Recognition Procedure The guideline provides information on conditions under which a medicinal product already authorised in the CR can be included into Mutual Recognition Procedure and its marketing authorisation number can       be maintained.
    • VYR-33-Ethylene oxide sterilization, sterilization by irradiation and estimation of the population of micro-organisms The aim of this guideline is to provide       manufacturers with GMP standards in the area of sterilization processes. The guideline amends document VYR-12 and sets basic principles of ethylene oxide sterilization, sterilization by irradiation and estimation of the population of micro-organisms on material.
  • Information
    • Outline of notifications on the use of non-registered medicinal products in the month of December 2004 The information on evaluated notifications in the month of December 2004, 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 December 2004
    • Information on Czech standards relating to medical devices published in the Bulletin of  the COSMT
    • 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 fourth quarter of 2004
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of December 2004
    • List of test facilities included in the national GLP programme in the field of medicinal products
    • List of medicinal products whose marketing authorisation will expire in March 2005 The validity of marketing authorizations of the listed products will expire during March 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 December 31, 2004.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of November 19, 2004 to December 29, 2004
    • Medicinal products authorised under the EU centralised procedure in the period from November 19, 2004 to December 29, 2004
    • List of specific therapeutic programmes approved during the period of November 19, 2004 to December 29, 2004