1. What is meant by "expiry of the marketing authorisation/registration" as referred to in Art 22 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG), also known as "sunset clause"?
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.
2. When a marketing authorisation/registration expires, will the marketing authorisation/registration holder receive an administrative decision (Bescheid), and will fees be payable?
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.
3. If a marketing authorisation/registration holder decides to again place a proprietary medicinal product on the market after its marketing authorisation/registration has expired, does a new application for marketing authorisation/registration have to be
Yes, a new application for marketing authorisation/registration has to be submitted, because a valid marketing authorisation/registration is no longer in place.
4. Considering that proprietary medicinal products whose marketing authorisation/registration has expired had already previously been approved/registered, do abbreviated or simplified procedures exist for such products?
No, an expired authorisation/registration will not be taken into consideration. New applications for marketing authorisation/registration for products whose authorisation/registration has expired will be handled in exactly the same way as other applications of the same type.
5. Will BASG inform me every time a marketing authorisation/registration is about to expire?
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.
6. How do I notify the BASG of the date of actual marketing in Austria?
Marketing data can be entered into the eService-Portal, as soon as the product has been brought to market.
The notification can exceptionally be done by email via email@example.com.
7. I do not wish to place a proprietary medicinal product on the market immediately after the product has been authorised/registered. What do I have to enter in the eService-Portal?
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 firstname.lastname@example.org.
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.
8. What exemptions to the provisions of Art 22 AMG ("sunset clause") are there, and how do I apply for such exemptions?
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 pallet is placed on the market, those parts of this pallet which are not placed on the market are not affected by the expiry of the authorisation/registration according to § 22 AMG.
- different pack sizes
- different strengths
- different dosage forms
- If duplicates (same marketing authorisation holder) are authorised but not all duplicates are marketed, these are not affected by the expiry of the marketing authorisation/registration pursuant to Section 22 AMG.
9. What is meant by „tatsächliches Inverkehrbringen“ ("actually placing on the market") as defined in the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG)? To comply with this requirement, is it enough to merely hold a number of packages on stock
„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.
10. Does a suspension of the marketing authorisation/registration have an effect on the 3-year period after which the marketing authorisation/registration will expire pursuant to Art 22 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG)?
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.
11. Do the provisions of Art 22 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) apply to all authorised and registered proprietary medicinal products?
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).
Austrian Medicinal Products Act - AMG §22
Regulation (EC) No. 726/2004 Article 14 (4-6)
Directive 2001/83/EC Article 24 (4-6)
Notice to Applicants Volume 2A Section 2.4.2