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SUKL Bulletin 10/2007

Contents of SUKL Bulletin 10/2007  


  • Contents
  • Front page news
    • Measures taken in the case of quality defects or adverse reactions to medicinal products in the month of September 2007
  • SÚKL guidelines
    • List of guidelines valid as of November 1, 2007
    • SLP-6 version 1 - National GLP Compliance Monitoring Programme The revision of the guideline is again a joint document containing components of       procedures for GLP monitoring covering both pharmaceuticals (the GLP       Monitoring Authority in the Czech Republic for pharmaceuticals is SUKL) and chemicals (this area is monitored by the National Inspection Authority NIO).
  • Laboratory control
    • Outcomes of projects finished by the Laboratory Control Branch The laboratory control branch performed, based on specific projects, controls of       medicinal products taken from the Czech market by inspectors. Outcomes of       the following projects are included: Verification of quality of generics: a) products containing enalapril , b) products containing omeprazole , c) products containing betaxolol hydrochloride , d) products containing ofloxacine , e) products containing loratadine (survey of quality and comparison with an original       product), Preparations containing ethanol (project verifying the quality of ethanol in drops) and Drops - a project for control of "Dose and uniformity of dose of oral drops" according to Ph. Eur. based on a justified complaint concerning dosage of one preparation.
  • Pharmacopoeia activities
    • Announcement of texts of the Czech Pharmacopoeia being recognized as official standards
    • Announcement of texts of the European Pharmacopoeia being recognized as official standards in the Czech Republic
  • Information
    • Announcement for regulated subjects Information for pharmacies, wholesalers and manufacturers notifies that Laboratory Control Branch of the Institute as       OMCL is a public institution which only performs laboratory testing for a       Competent Authority independently from manufacturers, wholesalers and/or       pharmacies.
    • Outline of notifications on the use of non-authorised medicinal products in the month of September 2007 The information on evaluated notifications in the month of September 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 September 2007
    • 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 detacheddepartments for dispensing pharmaceuticals and medical devices approved by SUKL in the third quarter of 2007
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of September 2007
    • List of medicinal products whose marketing authorisation will expire in December 2007 The validity of marketing authorisations of the listed products will expire during December 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 September 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 August 23, 2007 to September 26, 2007
    • Medicinal products authorised under the EU centralised procedure in the period from September 1, 2007 to September 30, 2007
    • List of specific therapeutic programmes approved in the period from September 1, 2007 to September 30, 2007