FAQ - Information Officer New
1. Who must report an information officer? New
Pursuant to § 56 (2) of the Austrian Medicines Act (AMG), as amended, and § 26 of the Austrian Veterinary Medicines Act (TAMG), as amended, the marketing authorisation holder (MAH) or holder of a registration is obliged to report an information officer to the Federal Office for Safety in Health Care (BASG). The MAH or registration holder must appoint a person with the necessary expertise and experience to fulfil this task to responsibly handle scientific information about the human and veterinary medicinal products placed on the market in Austria and must grant this person the necessary authority to fulfil these tasks. The appointment of information officers and any changes thereto must be reported to the BASG without delay.
2. How to report an information officer? New
Pursuant to § 56 (2) of the Austrian Medicines Act (AMG), as amended, and § 26 of the Austrian Veterinary Medicines Act (TAMG), as amended, the appointment of information officers and any changes thereto must be reported to the Federal Office for Safety in Health Care (BASG) without delay.
Any changes with regard to the information officer must be reported in advance or immediately to inspektionen@basg.gv.at using the appropriate form (F_I66 – Registration form for information officer).
3. What qualifications are required for information officers? New
The marketing authorisation holder (MAH) or registration holder must appoint a person with the necessary expertise and experience to responsibly handle scientific information regarding the authorised human and veterinary medicinal products placed on the market in Austria.
This person must also be granted the necessary authority to fulfil these responsibilities. Therefore, professional competence, language proficiency, and subject-matter knowledge are prerequisites for fulfilling the role of an information officer. These qualifications must be described in the appropriate form (F_I66 – Registration form for information officer) under the section “Qualification”.
4. Is it mandatory to appoint a deputy for the information officer? New
No, appointing a deputy is not mandatory. However, a deputy is recommended in case of potential absences of the information officer.
This can be indicated in the appropriate form (F_I66 – Registration form for information officer) in the optional data field.
5. Can information officers be appointed for specific human and veterinary medicinal products only? New
Yes, it is possible to appoint information officers for individual human and veterinary medicinal products, particularly for marketing authorisation holders (MAH) with a large product portfolio. However, the MAH or registration holder must appoint an information officer for each authorised or registered medicinal product (human and/or veterinary) of the portfolio placed on the market in Austria.
These must be listed in the appropriate form (F_I66 – Registration form for information officer) under the section “Optional: Information Officer for the following medicinal product(s)”.
7. Is reporting of an information officer required for centrally authorised human and veterinary medicinal products? New
Yes, even for centrally authorised human and veterinary medicinal products, an information officer must be reported to the Federal Office for Safety in Health Care (BASG) pursuant to § 56 (2) of the Austrian Medicines Act (AMG), as amended, and § 26 of the Austrian Veterinary Austrian Medicines Act (TAMG), as amended, if the human and veterinary medicinal products are placed on the market in Austria.
8. Who must sign the registration form if the information officer is not employed by the marketing authorisation holder? New
The form (F_I66 – Registration form for information officer) must be signed by the marketing authorisation holder or registration holder, as they are legally obliged to appoint an information officer, pursuant to § 56 (2) of the Austrian Medicines Act (AMG), as amended, and § 26 of the Austrian Veterinary Medicines Act (TAMG), as amended.
9. Can the responsibilities of an information officer be delegated to a call center? New
Pursuant to § 56 (2) of the Austrian Medicines Act (AMG) as amended, and § 26 of the Austrian Veterinary Medicines Act (TAMG), as amended, the marketing authorisation holder or registration holder must appoint a person with the necessary expertise and experience to responsibly handle scientific information regarding the authorised human and veterinary medicinal products placed on the market in Austria.
