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SUKL Bulletin 5/2006

Contents of SUKL Bulletin 5/2006  


  • Contents
  • Front page news
    • Measures taken in case of quality defects or adverse reactions to medicinal products in the month of April 2006
  • SÚKL guidelines
    • List of guidelines valid as of June 1, 2006
    • VYR-35-Procedure for licencing of manufacture of medicinal products and investigational medicinal products for the purpose of import from third countries The guideline is intended for subjects who apply for manufacturing licence in order to import medicinal products and investigational medicinal products from third countries or for manufacturers who apply for variation to their       manufacturing licence. The guideline sets up requirements to be met by       applicants for a manufacturing licence who wish to import medicinal products and investigational medicinal products, the course of approval procedure and system of inspections at manufacturing licence holders by SÚKL.
  • Information
    • Physicians and information on drugs - the survey made in the year 2005 Selected physicians were asked about sources of information on medicinal products that are prepared or approved by SUKL. Some questions were asked with the aim to evaluate the impact of mentioned information on their daily       practice. A drug bulletin Pharmacotherapeutical Information was the most       widely used source of information prepared by SUKL for physicians.
    • Up-to-date information for applicants submitting applications for approval of a clinical trial on products of the following nature: gene therapy medicinal products, somatic cell therapy medicinal products (including cells of xenogeneic origin) or medicinal products containing genetically modified organisms Following our existing experience with reviews of applications for approval of clinical trials on the above mentioned investigational medicinal products and the compexity thereof, the applicants (e.g. sponsors, contact persons, CRO) are kindly requested to inform the Institute of the intended submissions in advance (by e-mail: alice.nemcova@sukl_cz).
    • Outline of notifications on the use of non-authorised medicinal products in the month of April 2006 The information on evaluated notifications in the month of April 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 April 2006
    • 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 March 2006 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 first quarter of 2006
    • Overview of data on basic activities of the Inspection Branch in the first quarter of 2006
    • Overview of data on activities of the Medical Devices Branch in the first quarter of 2006
    • List of manufacturers and distributors of pharmaceuticals in the CR approved in the month of April 2006
    • List of medicinal products whose marketing authorisation will expire in July 2006 The validity of marketing authorizations of the listed products will expire during July 2006 and the products will be indicated 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 April 30, 2006.
  • Information on registered drugs and and approved specific therapeutic programmes
    • Authorised medicinal products and variations to marketing authorisations approved in the period of March 23, 2006 to April 19, 2006
    • Medicinal products authorised under the EU centralised procedure in the period from April 1, 2006 to April 30, 2006
    • List of specific therapeutic programmes approved during the period of April 1, 2006 to April 30, 2006