SUKL Bulletin 7/2005

Contents of SUKL Bulletin 7/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of June 2005
    • Announcement concerning medicinal products
  • SÚKL quidelines
    • List of guidelines valid as of August 1, 2005
    • VYR-34-Heat sterilisation processes The guideline provides the interpretation of GMP and Pharmacopoeias requirements for the heat sterilisation processes.       It replaces the guideline VYR-12 and compared to that guideline it is extended by metrological aspects in relation to qualification and validation of sterilisers. The guideline is complementary to the guideline VYR-33 describing the other sterilization processes.
  • Pharmacopoeia activities
    • Information on publishing of texts of the Czech Pharmacopoeia 2002 - Addendum 2005 becoming official standards
  • Information
    • Information on seminars held by SUKL in the 2nd half of 2005 - I. part The programme of seminars and the application form are included.
    • The common form of the Opinion of the Ethics Committee on Clinical Trial on Human Medicinal Products recommended for all Ethics Committees (Czech-English version)
    • Outline of notifications on the use of non-authorised medicinal products in the month of June 2005 The information on evaluated notifications in the month of June 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 June 2005
    • 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 second quarter of 2005
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of June 2005
    • List of medicinal products whose marketing authorisation will expire in September 2005 The validity of marketing authorizations of the listed products will expire during September 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 June 30, 2005.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from May 19, 2005 to June 15, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from June 1, 2005 to June, 30, 2005.