The Office PharmMed AGES has been known today as Medizinmarktaufsicht  / BASG.

The gradual implementation of the change of name on official documents, online services and printed materials will be completed by mid year. At the jurisdiction and responsibilities of the AGES PharmMed will remain the same.

The Federal Office for Safety in Health Care - AGES PharmMed is in the period from 2/23 - 2/27/2012 obtaining their new office location in Traisengasse. Specifically, the Institute approval and lifecycle management, pharmacovigilance, inspection, medical products and haemovigilance and the field line and their staff positions to move. The two sites in the OMCL Zimmermanngasse (1090) and the Possingergasse (1160) are not affected by the move.
 
The department is in the time of  2/22 closed until 2/26/2012. During this time, is a service of documents by courier not possible. We ask you to consider this fact in your work plan.
 
 the new address of the BASG from 2/27/2012

•  Traisengasse 5, 1200 Vienna

•  Phone / fax / e-mail will remain unchanged

• Possibility of EU marketing authorisations in Liechtenstein via Austria
• NEW: since 01 February 2011 there is the possibility of conditional marketing authorisations according to MRP/DCP with English texts

Important dates for submission:

• New: For drug imporation use of the
  web portal is obligatory                                                   04.07.2011
• Renewal for products already subjected to an
  Art. 19a procedure                                                             30.06.2012
• GI for products which previously had only an FI         31.12.2014

The MAH must get access via the PharMed to this portal

All proprietary medicinal products which already have been granted a renewal in accordance with Art. 19a of the previous version of the Marketing Authorisation Act (AMG), once again need to undergo a renewal procedure.
The final deadline is 30 June 2012.
Only companies that act now will be able to meet this deadline.

Please note that applications for Liechtenstein must be submitted separately as it does not come about automatically with the Austrian marketing authorisation.

Conditional marketing authorisation of a MRP/DCP in Austria if German texts are not submitted within the delivery deadline."

YES can help you  to develop an optimum strategy. Your product portfolio and the current status of your documentation will determine how much time and effort you will have to invest in order to maintain the viability of your products.

This would also be a good time to switch from Part II in the NtA format to Module 3 in the CTD or eCTD format. We will be glad to assist you.

Secure the support of YES in the following areas – now:

• Consulting
• Operational implementation

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