SUKL Bulletin 8/2005

Contents of SUKL Bulletin 8/2005  

 

  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of July 2005
  • SÚKL guidelines
    • List of guidelines valid as of September 1, 2005
    • UST-31-Principles for identification of human medicinal products in the CR The guidance specifies and explains use of the medicinal products identification codes in the Czech Republic.
    • REG-82-Guidance on the national procedure for authorisation of generic medicinal products The guidance describes steps of national authorisation procedure for generics. It is intended to provide the applicant with overview of timelines and individual steps within the authorisation procedure concerning his       application.
    • REG-83-Requirements on stability studies in registration dossier The guideline, which is based on the translation of Note for Guidance CPMP/QWP/122/02, STABILITY TESTING OF EXISTING ACTIVE SUBTANCES AND RELATED FINISHED PRODUCTS and CPMP/QWP/609/96, DECLARATION OF STORAGE CONDITIONS FOR MEDICINAL PRODUCTS IN THE PARTICULARS, gives information on data to be submitted with the application and recommendations on texts to be provided in package leaflet and labelling, if appropriate. The guideline replaces REG-49 and is valid as of September 1, 2005.
  • Information
    • Information for marketing authorisation holders on adjustment of MA numbers of some medicinal products
    • Instruction for successful delivery of e-mail messages to SUKL Due to potential problems with Internet communication, which are out of SUKL's control, in rare cases your e-mail message may not be delivered to the intended       addressees in SUKL.
    • List of hygienic service centres approved to carry out testing of purified water for pharmacies
    • Outline of notifications on the use of non-authorised medicinal products in the month of July 2005 The information on evaluated notifications in the month of July 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 July 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 June 2005 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.
    • Overview of data on basic activities of the Branch of Pharmacy and Distribution Control in the second quarter of 2005
    • Overview of data on basic activities of the Inspection Branch in the second quarter of 2005
    • Overview of data on activities of the Medical Devices Branch in the second quarter of 2005
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of July 2005
    • List of medicinal products whose marketing authorisation will expire in October 2005 The validity of marketing authorizations of the listed products will expire during October 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 July 31, 2005.
  • Information on authorised medicinal products and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period from June 16, 2005 to July 13, 2005
    • Medicinal products authorised under the EU centralised procedure in the period from July 1, 2005 to July, 31, 2005
    • List of specific therapeutic programmes approved during the period of June 1, 2005 to July 31, 2005