• marketing authorisation granted before 17.02.1994

If no application for renewal is submitted, the marketing authorisation expires with 01.01.2011 ex lege.

Documentation according to Art 19a Austrian Medicinal Products Act, as amended by law gazette no. 153/2005, already submitted at least once:
Art 94c para 10 Austrian Medicinal Products Act applies, stating that the documentation according to Art 20 para 2 and para 3, respectively, must be submitted until 30.06.2012 at the latest.
If no application for renewal is submitted, the medicine may be in circulation until 31.12.2012.

• marketing authorisation granted after 17.02.1994

Documentation according to Art 19a Austrian Medicinal Products Act, as amended by law gazette no. 153/2005, already submitted at least once:
Art 94c para 10 Austrian Medicinal Products Act applies, stating that the documentation according to Art 20 para 2 and para 3, respectively, must be submitted until 30.06.2012 at the latest.
If no application for renewal is submitted, the medicine may be in circulation until 31.12.2012.

• marketing authorisation granted after 02.01.2006

Marketing authorisations granted after 02.01.2006 are valid for 5 years.
Application for renewal as well as the documentation according to Art 20 para 2 and para 3, respectively, must be submitted in time; at the latest 9 months before expiry of the 5-year validity.

Documentation according to Art 19a Austrian Medicinal Products Act, as amended by law gazette no. 153/2005, submitted never before:
Art 94c para 11 Austrian Medicinal Products Act applies, stating that the documentation according to Art 20 para 2 and para 3, respectively, must be submitted until 01.01.2011 at the latest. The submission date is calculated in 5-year-steps starting from the date of marketing authorisation.

Yes, their validity is limited to 5 years, according to Art 20 Austrian Medicinal Products Act. Application for renewal as well as the documentation according to Art 20 para 2 and para 3, respectively, must be submitted in time.
Renewal of marketing authorisation/registration is issued by the Austrian Federal Office for Safety in Health Care via official notification and is no further subject to any temporary limitations.

Exception: For pharmacovigilance reasons, the Austrian Federal Office for Safety in Health Care can decree a further 5-year-limitation of the marketing authorisation's validity (cf Art 20 para 4 Austrian Medicinal Products Act).

No, for manufacturing procedures in terms of Art 7a para 1 Austrian Medicinal Products Act no application for renewal of the authorisation is necessary.

Renewal of the marketing authorisation according to Art 20 Austrian Medicinal Products Act must be issued via official notification before transition. This can be abandoned only if a renewal is assuredly initiated within the mutual recognition immediately after transition.

Renewal of marketing authorisation/registration can be applied for 4 years following legal validity of the official notification of the authorisation/registration at the earliest and until 9 months before the marketing authorisation/registrations ceases to be valid at the latest, i.e. before a period of five years following the legal validity of the authorisation/registration will have expired.

Changes to the periods of time scheduled for the application for renewal of marketing authorisation/registration in Art 20 para 2 and para 3 Austrian Medicinal Products Act must be approved by the Austrian Federal Office for Safety in Health Care. Extension of the temporal validity of 5 years cannot be achieved herewith.

See Following the Authorisation - Renewal of Authorisation

A product's lifecycle can be continued unrestrictedly and independently from the ongoing renewal-procedure. Variations need to be integrated into the most recently approved (!) product information texts. The submitted quality documentation can be the basis for variations.

In principle, data on the pharmaceutical development that need to be documented in the initial application dossier for the marketing authorisation will not be demanded within the scope of the renewal.
Data possibly directly connected to the medicine's safety and reflecting the current standard of knowledge are the only exception. Amongst others, these may be results concerning the breakability of tablets, compatibility studies for parenteral medicines and data on the shelf-life after first opening or an explanation for why this study is not deemed necessary, respectively.

Release and shelf-life specifications must meet the requirements of the current standard of knowledge. In most cases, release and shelf-life specifications need to be revised, particularly regarding contamination thresholds.

Batch analyses should be submitted for finished product batches not older than 3 years.

The Qualified Persons (QP) of every manufacturer responsible for batch release in the EEA and of every finished product manufacturer must declare that the active substance is manufactured according to the GMP requirements. Alternatively, such declaration may be signed by one Qualified Person on behalf of all QPs involved.

Yes. A declaration on the GMP-conformity of the active substance manufacturer(s) by the Qualified Person(s) of all manufacturers responsible for batch release and manufacturers using the active substance must be submitted. Alternatively, such declaration may be signed by one Qualified Person (QP) on behalf of all QPs involved (provided this is clearly indicated).

Even if the active substance manufacturer's GMP-certificate is provided, a respective QP-declaration must be submitted.

If the finished product is manufactured in a third party country without an agreement with the EEA upon mutual recognition (MRA), the competent authority of the member state the batches are released in is responsible for assessing the GMP-conformity of the finished product manufacture. The way of assessment of the GMP-conformity of the finished product manufacture is incumbent on that member state. Furthermore, a complete (re-)analysis as a basis for batch relase of the finished product must be performed by the Qualified Person in an Official Medicines Control Laboratory.

Yes, for further details please see: conditional approval.