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National authorisation Life-Cycle forms

National authorisation and registration

Electronic Application Forms have to be used for: New Applications according to §§ 7a, 9a, 9b, 9c, 9d, 10 Abs. 1(1), 10 Abs. 1 (2), 10 Abs. 9, 10a, 10b, 11, 11a and 12 AMG.

Variation application

Electronic Application Forms have to be used for: Variations according to Variation Regulation (EC) Nr. 1234/2008

Withdrawal of a Marketing Authorisation / Registration in Austria

Renewal

Electronic Application Forms have to be used for: Renewal Applications according to § 20 AMG

PSUR submission forms

Email

Further inquiry note

nat@basg.gv.at