If the conditions specified in Article 22 AMG are met, i.e., if a proprietary medicinal product is not placed on the Austrian market within a continuous period of three years after granting the marketing authorisation/registration, the authorisation/registration of the product expires automatically. The holder of the marketing authorisation/registration will be informed of the imminent expiry.
Yes, the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) is obliged to establish expiry of the marketing authorisation/registration by administrative decision (Bescheid). The fee for the issuance of the decision is based on the official Schedule of Fees.
However, pursuant to Art 23 para 1 (3) of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG), marketing authorisation/registration holders are free to relinquish the marketing authorisation/registration for their product at any time, in which case BASG is obliged to revoke the authorisation/registration. This revocation is not subject to any fees.
Yes, whenever an expiry of a marketing authorisation/registration in accordance with Article 22 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) is imminent, BASG will send a written reminder of the imminent expiry to the marketing authorisation/registration holder.
Please note: The notice sent is merely meant as a reminder and is not a prerequisite for Article 22 AMG become legally effective.
The marketing authorisation/registration holder has two weeks to respond or submit/correct the required marketing data.
Please note: If no marketing data are available, BASG will assume that the proprietary medicinal product has not been marketed.
If you do not want to place a proprietary medicinal product on the market immediately after authorisation/registration in accordance with Art 21 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG), no marketing notification can be done. The marketing data can be entered via eService-Portal soon as the product has been brought to market.
The notification can exceptionally be done by email via sunsetbasg.gvat.
Please note: The 3-year period pursuant to Art 21 AMG (‘sunset clause’) is calculated from the date of authorisation/registration. If a product is not placed on the market and if no exception has been granted in accordance with Art 22 AMG, the marketing authorisation/registration expires after this 3-year period.
Pursuant to Art 21 AMG, the marketing authorisation/registration holder is required to notify the BASG of the date of actual marketing of the medicinal product in Austria.
Exemptions from the sunset clause are possible:
- 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.
If none of the above mentioned reasons complies, marketing authorisation/registration holders can select the option “other exemption”.
„Inverkehrbringen“ (‘‘putting into circulation") is defined in Art 2 para 11 AMG, „tatsächliches Inverkehrbringen“ ("actually placing on the market") is defined in Art 21 AMG. Merely holding a number of packages in stock may be equivalent with ‘actually placing a product on the market’ as defined in Art 21 AMG; in this context, however, the provisions of Art 57a AMG have to be taken into consideration.
Whether or not a proprietary medicinal product can be considered to have "actually" been brought to market if only a few packages of the product are held in stock will depend on the type and nature of the product; a definitive decision can only be made on a case-by-case basis.
Yes, if a marketing authorisation/registration has been suspended in accordance with Art 23 para 3 AMG, the 3-year period pursuant to Art 22 AMG is also suspended. It is important to remember, however, that the suspension of a marketing authorisation/registration in accordance with Art 23 para 3 AMG is due to deficiencies which need to be resolved within an adequate period of time. If the deficiencies are not corrected or if it later becomes clear that the deficiencies cannot be corrected, Art 23 para 1 AMG stipulates that the authorisation/registration is to be revoked.
Art 22 AMG applies to all authorised proprietary medicinal products and to proprietary medicinal products registered in accordance with Art 12 AMG (traditional herbal proprietary medicinal products).
Art 22 AMG does not apply to registered homoeopathic proprietary medicinal products (Art 11 AMG) and allergens (Art 7a AMG).