SUKL Bulletin 2/2006

Contents of SUKL Bulletin 2/2006  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of January 2006
    • Measures taken in the case of adverse event to medical device
  • SÚKL quidelines
    • List of guidelines valid as of March 1, 2006
    • VYR-32-Guidelines on Good Manufacturing Practice - revision 1 The EU Commission has published Revision of GMP Guidelines, Part I: new GMP Provisions for Product Quality Review (Chapter 1), On-going Stability Programme (Chapter 6), new Annex 19 Reference and Retention samples and the basic       requirements for the manufacture of active substances used as starting materials as GMP Part II replacing the former GMP Annex 18. SÚKL is publishing the translation of changes only. Thefull version of GMP Guidelines is published on the SUKL website ( www.sukl.cz).
  • Information
    • Information for applicants regarding applicability of the new Administrative Procedure CodeSUKL informs that with effect from 1 January 2006 its activities will be governed by the new Administrative Procedure Code (Act No. 500/2004       Coll., as amended). This act introduces certain new provisions in administrative procedures:
      •   
      • Each participant may have simultaneously only one representative in        one proceeding;
      •   
      • Any person acting on behalf of the applicant must provide proof of        his/her authorisation;
      •   
      • SUKL may deliver to an electronic address, however, this delivery must be based on the request made by a participant in proceedings;
      •   
      • SUKL accepts documents in the Czech, Slovak and English languages,        documents in other languages have to be submitted with an authenticated translation.
    • Information for applicants regarding applicability of provisions of the Directive 2004/27/EC in the Czech Republic As a consequence of delayed transposition of Directive 2004/27/EC amending Directive 2001/83/ES on the Community code relating to medicinal products for human use, SUKL provides brief information for applicants on how to act when submitting applications. SUKL accepts applications submitted in accordance with the requirements stipulated by Directive 2004/27/EC.
    • List of medicinal products prescribed on prescription with blue strip (containing narcotic and psychotropic substances)
    • Outline of notifications on the use of non-authorised medicinal products in the month of January 2006 The information on evaluated notifications in the month of January 2006, 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 January 2006
    • 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 fourth quarter of 2005
    • Overview of data on basic activities of the Inspection Branch in the fourth quarter of 2005
    • Overview of data on activities of the Medical Devices Branch in the fourth quarter of 2005
    • List of test facilities included in the national GLP programme in the field of   medicinal products
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of January 2006
    • List of medicinal products whose marketing authorisation will expire in April 2006 The validity of marketing authorizations of the listed products will expire during April 2006 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 January 31, 2006.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of December 15, 2005 to January 18, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from January 1, 2006 to January 31, 2006
    • List of specific therapeutic programmes approved during the period of January 1, 2006 to January 31, 2006