Lifecycle

Austrian Medicinal Product Index

According to Art 27 AMG the Austrian Medicinal Product Index is published by BASG (Federal Office for Safety in Health Care) where defined data of all authorised and registered medicinal product including their product informations (SmPC and PL) can be found.

In addition, the national public assessment report (PAR), which is derived from the assessment during the evaluation process, is made available to the public after deletion of commercially confidential information.
PARs of European evaluation processes (MR/DC or centralised) are published in English, those of national procedures in German.

If Austria is concerned member state, a link to the reference member state's website is published. The maintenance of this publication is the responsibility of the RMS.
If the medicinal product is authorised in a centralised procedure, a link to the European Medicine Agency's website is published. The maintenance of this publication is the responsibility of the EMA.

Variations

Variations are made ​​either on the basis of the Variation Regulation (EC) No 1234/2008, as amended or according to Austrian Drug Law (Arzneimittelgesetz, AMG).

Information about the transmission of documents see Guidance notes: Electronic Position Regulation EEVO (L_Z45).

Renewal of marketing authorisations according to Art 20 Austrian Medicinal Products Act (Arzneimittelgesetz, AMG)

Basically, the marketing authorisation of a medicine and the registration of a traditional herbal medicine are valid for five years.

For marketing authorisations with a re-evaluation period ending after 21.04.2013, a renewal can be applied for to the Austrian Federal Office for Safety in Health Care until 9 months before the marketing authorisation ceases to be valid at the latest, i.e. before a period of five years following the legal validity of the authorisation or registration, respectively, will have expired.

Documentation to be submitted for a renewal

National procedures and MR/DC-procedures:

Information about the transmission of documents see Guidance notes: Electronic Position Regulation EEVO (L_Z45).

Documentation to be submitted according to Annex 2 of the CMD(h) Best Practice Guide

*quality documentation HUMAN:
As a general rule, every application for renewal of a marketing authorisation has to include complete and consolidated quality documentation. Submission of a CTD standard is urgently recommended, particularly for electronic dossiers. In individual cases, reference to a quality documentation that has already previously been assessed and is still up to date and not older than four (4) years is possible, provided that no changes have meanwhile occurred.

*quality documentation VETERINARY:
Please submit the line listing of changes to the quality documentation throughout the life cycle of the veterinary proprietary medicinal product. For more information on electronic submissions, please refer to the Guideline on the specifications for provision of an electronic submission (e-submission) for a veterinary medicinal product

FAQs

For FAQs on this topic click here.

Sunset Clause - expiry of the marketing authorisation/registration as referred to in Art 22 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG)

In January 2009 the regulation of the so-called sunset clause came into effect. Art 22 para 1 AMG applies to all authorised medicinal products and to medicinal products registered in accordance with Art 12 AMG (traditional herbal medicinal products), if a product is not placed on the market in a 3-year period.

According to Art 22 para 2 AMG exemptions can be granted by the BASG:

Exemptions

For marketing authorisations/registrations for proprietary medicinal products that are authorised/registered for the sole purpose of being exported in accordance with Art 9a para 5 AMG.

  • When Austria acts as reference member state (RMS), the proprietary medicinal product has not been placed on the market in Austria but is marketed in the concerned member states (CMSs).  
  • If the product cannot be marketed in Austria for reasons of patent protection.
  • If only part of a product range (e.g. one strength) is brought to market, the marketing authorisation/registration of those parts of the product range that are not marketed will not expire in accordance with the provisions of Art 22 AMG.
  • Other justified reasons (eg on public health grounds).

BASG reserves the right to verify the accuracy of the information provided by the marketing authorisation/registration holder.

How to report the marketing status

Marketing data can be entered into the eServices, as soon as the product has been placed on the market. 

user registration

The notification can exceptionally be done by email via sunsetbasg.gvat.

FAQs

For information see the corresponding FAQs.

Withdrawal of the marketing authorisation pursuant to §23 AMG

Admission/registration may be revoked either at the request of the holder of the admission/registration or ex officio. Form (F_Z59) shall be used.

The costs for a cancellation are covered by the annual fee (valid from 02.01.2014).

The authorisation expires on the date of cancellation (§23 AMG) and the medicinal product may no longer be placed on the market. There are no sales deadlines.

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