SUKL Bulletin 6/2005

Contents of SUKL Bulletin 6/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of May 2005
  • SÚKL quidelines
    • List of guidelines valid as of July 1, 2005
    • PHV-5-Plan for transfer of pharmacovigilance obligations The guideline sets out a template for plan for transfer of pharmacovigilance obligations       related to the transfer of marketing authorization. It describes in detail the way of transfer planning from the old to the new marketing authorization holder in order to ensure continuity of pharmacovigilance process.
  • Information on drug consumption
    • Team of authors: Drug "consumption" in the Czech Republic in the 1st quarter of the year 2005 Comparison with the situation in the previous period is given. Figures are expressed in number of packages, Czech crowns and Defined Daily Doses.
  • Pharmacy activities
    • Control of pharmacies in the year 2004 Out of the total number of 3 657 samples taken from pharmacies 13 % of samples were found to be non-compliant and 7,2 % of samples were found "non-compliant with adjustment". The number of non-compliant samples from pharmacies continues to be relatively high, but since 2003 the quality of medicinal products and purified water prepared in pharmacies has slightly improved.
  • Information
    • Information for persons interested in the topic "regulations related to Advanced Therapy Medicinal Products"
    • Outline of notifications on the use of non-authorised medicinal products in the month of May 2005 The information on evaluated notifications in the month of May 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 May 2005
    • 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 2004 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 manufacturers and distributors of pharmaceuticals in the CR approved in the month of May 2005
    • List of medicinal products whose marketing authorisation will expire in August 2005 The validity of marketing authorizations of the listed products will expire during August 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 May 31, 2005.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from April 21, 2005 to May 18, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from May 1, 2005 to May, 31, 2005
    • List of specific therapeutic programmes approved during the period of May 1, 2005 to May 31, 2005