Renewal of marketing authorisation

1. Which deadlines for application for renewal according to para 20 Austrian Medicinal Products Act need to be considered for my medicine (human and veterinary)?

  • marketing authorisation granted before 17.02.1994

If no application for renewal is submitted, the marketing authorisation expires with 01.01.2011 ex lege (fees accrue!).

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.
According to the Regulation issued by the Federal Office for Safety in Health Care regarding the Schedule of Fees pursuant to the Act on Safety in Health and Food, a reduced fee of 900 € accrues.
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.
According to the Regulation issued by the Federal Office for Safety in Health Care regarding the Schedule of Fees pursuant to the Act on Safety in Health and Food, a reduced fee of 900 € accrues.
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.

2. Are marketing authorisations (human and veterinary) issued after 02.01.2006 granted temporarily?

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).

3. Is an application for renewal necessary for medicines, whose manufacturing procedure is authorised according to Art 7a para 1 Austrian Medicinal Products Act (antigens/allergens for desensitising)?

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

4. What ist the approach for medicines transitioning from a national marketing authorisation to mutual recognition status due to a referral procedure?

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.

5. After initial marketing authorisation/registration, when can I apply for renewal of the authorisation/registration according to Art 20 Austrian Medicinal Products Act at the earliest?

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.

6. Which documents have to be submitted in accordance with Art 20 Austrian Medicinal Products Act as amended?

See Following the Authorisation - Renewal of Authorisation

7. Given the estimated assessment period, will it be possible to continue the lifecycle based on the submitted dossier (human and veterinary)?

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.

8. Will data on the pharmaceutical development be demanded within the scope of the renewal?

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.

9. Within the scope of the renewal, to what extent does the update of quality documentation refer to the release and shelf-life specifications and the associated batch analyses?

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.

10. What is the maximum age of batches controlled for documentation of the finished product's quality to be submitted for the renewal?

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

11. Who must confirm the GMP-conformity of the active substance manufacturer?

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.

12. Do the Qualified Persons have to confirm the GMP-conformity of the active substance manufacturer even if the active substance manufacturer has a GMP-certificate?

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.

13. If the finished product is manufactured in a third party country without an agreement with the EEA upon mutual recognition (MRA), how is GMP-conformity assessed?

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.

14. For a medicine authorised via MR-/DC-procedure, is it possible to close the national phase of the renewal without German texts?

Yes, for further details please see: conditional approval.

Created: 13.04.2009 | Page last modified: 23.01.2015

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