Authorisation/registration applications

1. Where do I send my application to and in which form?

For information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

2. Method of payment? When do I have to transfer the fee?

Transfer the fee to the following account:

BAWAG P.S.K. AG
IBAN: AT59 6000 0000 9605 1496
BIC/SWIFT: BAWAATWW
DVR: 2112611

We do not accept cheques.

Even with the new Fee Regulation, no fees are payable before submission of an application for marketing authorisation. After the documents have been received and undergone an assessment of the formal requirements, an invoice will be sent to the applicant. If the applicant withdraws an application for marketing authorisation before completion of the formal assessment, the fee payable will be 10 % of the total applicable fee. If the application is withdrawn after the completion of the formal assessment, the total applicable fee will be payable.

3. When, how and in which form should I submit electronic texts (SmPC, PIL, LAB)?

For information at the time of and kind of the transmission see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

Can the PILs for several strengths be combined into one combined PIL?

Combining PILs for various strengths into one document may be permissible when this is in the interest of the patient or for products intended for clinical use. Also, the criteria published in the “Compilation of QRD decisions on stylistic matters in product information” must be fulfilled:

  • The SmPC/PIL foresees more than one dosage (e.g. a high dose at the start of therapy followed by a lower maintenance dose).
  • The PILs are identical, with the exception for the few strength-specific details.
  • The combined PIL does not create any risk of confusion for the patient or user.

Only when these criteria are fulfilled a combined PIL can be submitted. For national submissions, a justification should be included (sending an e-mail is sufficient). The decision as to whether combining PILs for several strengths into one is acceptable will be made on a case-by-case basis.

4. Further information and help with application forms

 

Guidance for using and completing eAFs see here.

5. How are applications processed?

Processing of all applications is performed in the order of the date of receipt. Average pass-through times and processing times as well as further key performance indicators are routinely collected and our processes constantly are reviewed for further optimisation. Hence, we were successful in keeping  processing times constant and in some cases to even reduce them.

 

The duration of processing is always linked to the quality and completeness of submitted documents and product information as well as to the rapid responding to outstanding issues.

 

Installation of various peer review systems during assessment guarantees consistent decisions.

 

Currently, it is not possible to make visible assessors and status of procedures on eServices. For further information please refer to our contact details (http://www.basg.gv.at/en/about-us/contact-us/) respectively contact corresponding Heads of Department.

Created: 13.04.2009 | Page last modified: 12.06.2015

© Austrian Federal Office for Safety in Health Care
to top