Deadline for the extension of the authorisation of existing products
We would like to point out that the deadline set in accordance with Section 94c(10) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, for the submission of documents relating to an extension of the marketing authorization will expire in a few weeks.
For all medicinal products that have already been renewed at least once in accordance with Section 19a of the AMG, an application for renewal in accordance with Section 20 of the AMG must be submitted to the Federal Office for Safety in Health Care (BASG) by 30 June 2012 at the latest. An extension of this deadline is not possible.
§Section 94c paragraph 10 reads:Also medicinal products that were approved before the entry into force of this Federal Act in the version of Federal Act BGBl. I No. 153/2005 and the existence of the approval requirements has already been proven once according to Section 19a of this Federal Act in the version before the entry into force of Federal Act BGBl. I No. 153/2005, are subject to the provisions of Section 20. The submission of the documents required according to Section 20 paragraph 2 or 3 must be made by 30.06.2012 at the latest if the approval otherwise expires. The Federal Office for Safety in Health Care shall determine the expiry by notice. If the documents are not submitted in time, the products may still be placed on the market until the end of December 31, 2012.
Please note that none of the stated deadlines can be postponed, as the BASG is obliged to report to the European Commission on the measures taken.
Further inquiries:
Institute Approval & Lifecycle Management
Sonja Königshofer
E-Mail: lcm@ages.at
