Legal basis: Austrian fee regulation Annex II (valid from 02.01.2014)
1. What services are paid for by the flat rate annual fee and how is it payable to AGES/MEA?
The flat rate annual fee for the life cycle includes the following items:
• Applications pursuant to § 24 AMG ( e.g. changing classification of prescription status)
• Applications under Regulation (EC ) No 1234/2008 (variations to licences)
• Renewal of marketing authorisation
• Renewal of national registration according to § 20 AMG.
• Change of ownership of marketing authorisation pursuant to § 25 AMG
• Assessment of requirements related to the marketing authorisation
• Suspension or withdrawal of the authorisation according to § 23 AMG
• sunset clause notification or request for public health exemption pursuant to § 22 AMG
Annual fee does not apply for duplicates and pallet discounts.
Not included are also "special requests " such as
• inclusion of a QR-Codes/Speech-Codes on the commercial pack or PIL texts
• request for exemption from the batch release according to § 26 AMG.
The ¼ of the annual fee is payable for each medicinal product with marketing authorisation valid as per the last working day of the recent quarter.
Marketing authorisation approved during the recent quarter are also due for payment.
Marketing authorisation/registration suspended are not subject to the pro rata annual fee.
Withdrawal of a marketing authorisation ceases obligation for that quarter.
2. The marketing authorisations/registrations were withdrawn before the end of the quarter. Nevertheless, they were still considered for the annual fee.
As part of the revision of the fees regulation of BASG, agreement was reached involving the stake holders concerned, introducing a flat-rate annual fee, charged proportionately, on a quarterly basis.
The fee is to be prescribed retrospectively at the end of each quarter concerned.
The reference date is the last business day of the applicable quarter. Consequently, an invoice will be sent for all MAs/registrations being valid on the reference day.
Concerning the valid date of withdrawal of the marketing authorisation/registration:
The BASG incoming date of the application for withdrawal is not relevant.
The validity of withdrawal starts with the date of the withdrawal decision of the BASG.
Application requiring a future withdrawal date will be considered, if applied for at least one month in advance. For shorter terms, the date of the BASG decision will not be postponed.
Applications for withdrawal are recorded in the order of receipt by BASG.
A specific time prediction on processing, announcement and delivery of the BASG withdrawal decision is not possible, due to the unforeseeable incoming situation.
Therefore, it is highly recommended to apply for withdrawal as early as possible, preferably in the first half of the quarter targeted, to receive the withdrawal decision before the last day of that quarter.
Created: 20.01.2014 | Page last modified: 20.04.2015