Deadline according to the Medicines Act

At the end of 2010, the following deadlines will expire according to the Medicines Act BGBl Nr 185/1983 as amended:

Inclusion of doping warning until 31.12.2010

• All medicinal products concerned must contain the doping warning by 31.12.2010 (according to § 94g AMG). This is done as a change according to § 24 paragraph 6 AMG; subject to notification.
• If the notification is received in due time, proprietary medicinal products may be marketed for one year without this change.
• Proprietary medicinal products already on the market may remain on the market until their respective expiry date.

Conversion of the technical information and instructions for use to the QRD format by 01.01.2011

• The package leaflet and directions for use must comply with the QRD template as of 01.01.2011 (according to § 94c (2) AMG).
• Inclusion of Braille on outer packaging by 01.01.2011
• All medicinal products must contain Braille on the labeling by 01.01.2011 at the latest (according to § 94c (5) AMG).
• If the labeling of a commercial package already on the market does not comply with the provisions of § 17 (5) AMG, it may nevertheless continue to be dispensed.

Extension of the marketing authorization according to § 20 AMG

• If a marketing authorization was granted before February 17, 1994, which was never extended according to § 19a, an application for extension according to § 20 AMG must be submitted by January 1, 2011 (according to § 94c (11) AMG).
• If the application for renewal is not submitted, the marketing authorization expires.

In the event of non-compliance with the above deadlines, the Federal Office for Safety in Health Care will take the appropriate procedural steps.

Further inquiries:

AGES PharmMedInstitute Regulatory Affairs & Lifecycle Management

DI Dr. Christa Wirthumer-Hoche

Phone: +43 (05)50 555-36500

E-mail: c hrista.wirthumer-hoche@ages.at

Further inquiry note

basg@basg.gv.at