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 Mutual Recognition Index 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 are made ​​either on the basis of the Variation Regulation (EC) No 1234/2008, as amended or according to Austrian Drug Law (Arzneimittelgesetz, AMG). Variations for veterinary medicinal products are regulated in Regulation (EU) 2019/6.

Entry into force of the amended Regulation 1234/2008/EC on the examination of variations to the terms of marketing authorisations for medicinal products for human use on 01.01.2025

Regulation 1234/2008/EC was amended by Delegated Regulation (EU) 2024/1701 and will enter into force on 1 January 2025.

The most important points concern changes to the Article 5 procedure, annual updates for minor variations of type IA ("Annual Report"), the procedures for grouping and super-grouping of type IA variations, the annual updates on human influenza and coronavirus vaccines, mandatory (same marketing authorisation holder) or voluntary (different marketing authorisation holders) worksharing procedures and variations to vaccines in the event of public health emergencies.

Variations submitted before 1 January 2025 will continue to follow Regulation 1234/2008/EC, as amended by Delegated Regulation (EU) 2021/756, until their finalisation.

Publication of the update of the corresponding guidelines is expected in the second quarter of 2025.

Further link:
Heads of Medicines Agencies: Variation
 

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

FAQs on Variations

Basically, the marketing authorisation of a human medicinal product and the registration of a traditional herbal human medicinal product 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.

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 3 of the CMD(h) Best Practice Guide

*quality documentation HUMAN:
In principle, a complete update of the quality documentation in consolidated form must be included with each application for renewal of the marketing authorization. Renewal applications have to be submitted in eCTD format in the MR procedure since January 1, 2018 and in the national procedure since January 1, 2019. In these cases, no consolidated Module 3 (no quality documentation in consolidated form) is required.
In exceptional cases, it is possible to refer to documents that have already been assessed and are still up-to-date, provided that they are not older than 4 years and there have been no additional changes in the meantime.

Pharmacovigilance data for the renewal procedure are listed  in the FAQ Pharmacovigilance!

For FAQs on this topic click here.

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:

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.

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 sunset@basg.gv.at.

For information see the corresponding FAQs.

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.

According to Article 63(3) of Directive 2001/83/EC and according to § 16(6) and § 17(10) AMG (Austrian Medicinal Products Act, “Arzneimittelgesetz”), certain exemptions from the legal requirements for package leaflet (PL) and labelling (LAB) may be granted for medicinal products that are not delivered directly to patients or in case of severe availability problems.

The provisions of Article 63(3) apply to centrally authorised medicinal products (CAPs), whereas the provisions of §§ 16(6)/17(10) AMG apply to purely national and decentralised marketing authorisations (MRPs/DCPs).

In both cases, the same principles apply to purely national exemption requests:

• Regular marketing of foreign packs in AT is not possible, for temporary import of foreign packs there is the option of import according to the Austrian Medicines Import Act (“Arzneiwareneinfuhrgesetz”, AWEG)
• Exemption requests are processed separately and independently from regulatory procedures
• Granted exemptions only apply to the printed materials
• The requested exemptions must be sufficiently justified

No exemption application is required for the marketing of multilingual packs, provided that one of the languages used is German.

Basically, there are three distinct exemption scenarios with different procedures:

a) National exemptions according to article 63(3) of Directive 2001/83/EC für CAPs

Details regarding these exemption requests and the respective Guideline are available on the EMA Website (Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure, EMA/135540/2019 rev.4*).

Basically, these are national applications for permanent exemption from the translation obligation with the aim of marketing the product concerned in AT with one or more packaging component(s) in English ("multi-country packaging", taking into account the national country-specific information/‘Blue-box’ Requirements for AT).

Corresponding applications including the required documentation (see Annex I of the above mentioned Guideline) should be submitted via email to qrd@basg.gv.at with a meaningful subject.

b) National exemptions according to § 16(6)/§ 17(10) AMG for purely national and decentralised marketing authorisations (MRPs/DCPs)

These are national applications for permanent exemption from the obligation to provide the package leaflet (PL) and/or labelling (LAB) in German and from the obligation that certain particulars must appear in PL and/or LAB, with the aim of marketing the product concerned in AT with one or more package component(s) in English ("multi-country package" taking into account the country-specific information/‘Blue-box’ Requirements for AT).

The BASG has to decide within 45 days after receipt of an application. After completion of the assessment, a corresponding decision will be issued.

Please address any questions to qrd@basg.gv.at.

A detailed description of the procedure for exemption requests pursuant to § 16(6)/§ 17(10) AMG can be found in the guideline. The guideline and the respective request form (F_Z90) can be found in the downloads section.

c) Import and shipment of medicines according to AWEG

Regular marketing of foreign packs in AT is not possible (e.g. Irish packs in English language), not even in case of German-language packs (e.g. trilingual Belgium packs, German packs). This applies to national/decentralised and centralised marketing authorisations.

For temporary import of foreign packs to AT (language not necessarily English, country-specific information/‘Blue-box’ Requirements of the country of origin), e.g. in case of an existing or anticipated shortage, there is the possibility of import/shipment according to the Austrian Medicines Import Act.

Information on import of medicines can be found on our website and the related FAQs. For specific questions, please contact inspektionen@basg.gv.at.

qrd@basg.gv.at