The Federal Office for Safety in Health Care takes great care in providing information on drug specialties, procedure completions as well as reconciliations of the Federal Office for Safety in Health Care on this website and via data interfaces.

However, despite the greatest possible care, errors cannot be completely ruled out.

If, for example, there are inconsistencies with regard to the specialist or usage information enclosed with the medicinal product and information on the pages of the Federal Office for Safety in Health Care, the content of the respective technical or usage information for use shall apply.

For legally binding information, please contact us at basg@basg.gv.at.

The Federal Office for Safety in Health Care therefore accepts no liability for the accuracy, completeness and actuality of the content. In particular no liability is accepted for any direct or indirect damage arising from the direct or indirect use of the content provided.

In the event of any failure to use the website, electronic data provision and data interfaces due to technical or organizational faults, no claims of any kind whatsoever can be made against the Federal Office for Safety in Health Care. If you download, obtain and further use the data and content offered, the content may not be changed and further use is at your own risk.

Use of data interfaces (web services)

When using a BASG data interface, the corresponding terms of use are deemed to be accepted; no further explicit consent is required.

Note on the availability of medicinal products

It is further pointed out that the Register of Proprietary Medicinal Products exclusively reflects the marketing authorization status of a proprietary medicinal product; it depends on further factors outside the area of responsibility of the BASG whether the proprietary medicinal product is actually marketed in Austria. In this context, please also refer to our information on the availability of medicinal products.

The terms of use are composed of the applicable submission regulation of the Federal Office for Safety in Health Care and the provisions listed below.

It should be noted that each authorized person has to register only once. This is because the initial registration as a user includes a so-called 'administrator authorization'. In order to obtain this authorization a  legitimation of  management board, a so-called Letter of Authorization (LoA), is required. In addition, an actual valid excerpt from the company register (or a foreign equivalent) must be provided.

Administrators can grant (administrator) rights to other persons in their area of responsibility, make changes to these rights or withdraw them again. The creation of additional users is done by the administrator. The administrator agrees that his contact data will be passed on for this purpose. If additional users are granted rights by the administrator, the same duties of care regarding user identification and personal password apply to these authorized persons as to the administrator himself.

If an already created organization requests another registration, the administrator of the already created organization will be informed.

The user identification and the personal password must be kept carefully in order to prevent unauthorized access  by third parties.

The administrator will be informed about changes of the terms of use by e-mail.

The following privacy policy is intended to provide you with an overview of how your personal data is processed when you register for eServices.

Registration for eServices: The Austrian Agency for Health and Food Safety GmbH (AGES), Spargelfeldstraße 191, 1220 Vienna, is responsible for the processing of the personal data during registration for eServices. The data protection officer of AGES can be contacted at datenschutz@ages.at.

Use of eServices: You can use various services within eServices. Depending on the service you use, responsibility lies either with AGES or with the Federal Office for Safety in Health Care (BASG). You can find more detailed information on this in section 2.

Categories of data processed
Personal data is data and information that can be traced back to a specific or identifiable person. Examples: name, address, telephone number, email, etc.
The following data is collected during registration for eServices:

Organization:

• Company name (mandatory)
• Street (mandatory)
• House number (mandatory)
• Postal code (mandatory)
• Place (mandatory)
• Federal State
• Country (mandatory)
• OrgID
• LocID
• Phone number (mandatory)
• Mobile phone number
  Fax
• E-Mail
• Homepage
• VAT identification number
• Company registration number
• GLN (Global Location Number)
• DUNS number

Administrator:

• Title (mandatory)
• Academic title
• First and last name (mandatory)
• Street, house number (= pre-filled from the organization's address) (mandatory)
• Building code, floor, room
• Postal code, place (= pre-filled from the organization's address) (mandatory)
• Federal State (= pre-filled from the organization's address)
• Country (= pre-filled from the organization's address) (mandatory)
• Phone number (mandatory)
• Mobile phone number
• Fax
• Personal email address (mandatory) (will be used as username)

In addition, the following documents must be uploaded during registration:

• Letter of authorization
• Proof of company data with the address of the company

Purposes and legal basis for data processing

The personal data referred to in point 1 is entered by users who wish to register during the registration process.

After registering for eServices, various services can be used. Depending on which service is used, data processing and responsibility for compliance with data protection regulations falls under the responsibility of AGES or BASG.

The tasks of AGES are defined in § 8 of the Health and Food Safety Act (GESG), Federal Law Gazette I No. 63/2002, as amended. In fulfilling these tasks, AGES is authorized to process personal data in accordance with § 9 (7) GESG. In addition, personal data is processed on the basis of legal obligations, which result in particular from relevant substantive laws.

The tasks of BASG are defined in § 6a (1) GESG. To perform these sovereign tasks of BASG, AGES is entitled to process personal data for the purpose of registration for eServices for BASG in accordance with § 6a (5) in conjunction with § 9 (7) GESG. Regarding the basis for data processing by BASG please refer to the Privacy notice - BASG.

Transfer of your personal data

Personal data may be transferred e.g. to authorities and international organizations, as well as to service providers for the purpose of fulfilling contracts, in particular based on relevant legal obligations, or on the basis of your consent in this regard. In all cases, we ensure that a consistent level of data protection is maintained.

Data security/technical and organizational measures

AGES has the following technical and organizational measures in place: access control, system access control, data access control, data transfer control, ensuring system availability and resilience, control procedures to guarantee the security of processing and personnel (training) measures.

Your rights in relation to personal data

Under applicable law, you are entitled, provided that the respective requirements of the applicable law are met:

• to request confirmation as to whether and which of your personal data we process and to receive copies of this data;
• to request the correction or deletion of your personal data;
• to request that we restrict the processing of your personal data;
• object to the processing of your personal data;
• to withdraw any consent previously given for processing (withdrawal of your consent does not affect the lawfulness of processing based on your consent prior to withdrawal);
• to request data portability; and
• to lodge a complaint with the Austrian Data Protection Authority.

The following restrictions on the rights of data subjects are provided for by law:
Pursuant to § 9 (8) GESG, in fulfillment of the tasks pursuant to § 8 GESG with regard to the processing of personal data, the rights and obligations pursuant to Articles 13, 14, 18, and 21 of the General Data Protection Regulation (GDPR) are excluded by law.

Insofar as the personal reference is indispensable in the further processing of personal data for scientific or historical research purposes, the rights of the data subjects pursuant to Article 15 GDPR (right to information), Article 16 GDPR (right to rectification), Article 18 GDPR (right to restriction of processing) and Article 21 GDPR (right to object) may be excluded by AGES if these rights would make it impossible or seriously impair the achievement of the specific purposes (§ 9 (9) GESG).

Storage period

We store the personal data you provided during registration (i) for the duration of your use of the services. Longer storage only takes place (ii) as long as there are legal retention obligations or (iii) as long as any legal claims for which the personal data is required for assertion or defense are not yet time-barred, or (iv) you have given us your express consent to do so.

There is no obligation to delete personal data if processing is necessary for the following purposes:

• To exercise the right to freedom of expression and information,
• To fulfill a legal obligation,
• For reasons of public interest in the area of public health pursuant to Art. 9 (2) lit. h and i and Art. 9 (3) GDPR,
• For archiving purposes in the public interest, scientific or historical research purposes or statistical purposes pursuant to Art. 89 (1) GDPR, insofar as the right referred to in Art. 17 (1) GDPR is likely to render impossible or seriously impair the achievement of the objectives of this agreement, or
• For the establishment, exercise, or defense of legal claims. 

Contact

If you have any questions regarding the processing of your personal data during registration, please send an email to datenschutz@ages.at.

Profiling

AGES does not actively use the personal data you provided during registration for automated decision-making.

Changes to this privacy policy

We reserve the right to amend this privacy policy.

Supervisory authority

Austrian Data Protection Authority
Barichgasse 40-42, A-1030 Vienna
Phone: +43 1 52 152-0
Email: dsb@dsb.gv.at

Timeliness of the data in the Register of Proprietary Medicinal Products and BASG pronouncements

Data is updated over night and the completion date is indicated with day and time in the register. Documents can always be retrieved live.

Retrieval of data and documents

In order to avoid interference with IT systems, if necessary, data and document retrievals may be restricted in terms of quantity or data.

Download of data from the Pharmaceutical Specialties Register to Excel

The file name is: ASPRegister.xls .as HTM / HTML format with .xls file extension.

The size of the whole export to Excel is about 6 MB.

The following message is displayed during the download and is system dependent:

"Microsoft Excel: "You are trying to open a file, 'ASPRegister.xml', whose format is different from the one specified in the file extension. Make sure that the file is not corrupted and comes from a trusted source before opening the file.

Do you want to open the file now? (YES / NO / HELP)."

Calling up documents from the drug specialities register

It is possible to call documents directly. For this purpose, the approval number and the type of the document must be specified: https://medikamente.basg.gv.at/de/medicinal-products

for package leaflet: DOTC_GEBR_INFO

for technical information: DOTC_FACH_INFO

Please note that not all document types are always available.

Examples for ABC Local Pain Therapy Heat Cream 75 (documents in German)

Instruction for use

Summary of product characteristics

Accessibility of documents from the Register of Proprietary Medicinal Products

The Federal Office for Safety in Health Care (BASG) is obligated under Section 27 of the German Medicines Act to enter drug specialties that have a marketing authorization, registration, or approval for parallel import into the Drug Specialties Register. The BASG does not assume any responsibility for the accessibility of the documents listed in the Register of Proprietary Medicinal Products; the accessibility of these documents is the responsibility of the marketing authorization holder.

The following terms of use apply to data provision at: https://termgit.elga.gv.at/:

LIABILITY AND TERMS OF USE

AGES takes great care in providing information on medicinal products of the ELGA measure "e-Medication" (§ 16a GTelG 2012 idgF) and eImpfass.

However, despite the greatest possible care, errors cannot be completely excluded. If, for example, there are inconsistencies between the specialist information or instructions for use enclosed with the medicinal product and the information on the content of the terminology server, the content of the respective specialist information or instruction for use shall apply. In the case of differences to information in the Pharmacist Publisher's List of Goods, the information in the List of Goods shall apply.

Parts of the data provided originate from catalogues of the Apothekerverlag, the EMA (European Medicines Agency, SPOR Services), or the EDQM (European Directorate of the Quality of Medicines).

The further use of this data is subject to the respective copyright and terms of use of these providers. For EMA, these conditions can be found on the following EMA website 'About RMS': https://spor.ema.europa.eu/rmswi/.

AGES accepts no liability for any direct or indirect damage arising from the direct or indirect use of the content provided.

If the offered data and contents are downloaded and further used, the contents may not be changed and the further use is at the user's own risk.

AGES provides no guarantee and accepts no liability for a certain data quality of externally provided content, for the quality of the data sets and/or code systems created, or for the usability and/or use of the data made available, insofar as its defectiveness was not, or could not have been, apparent to AGES despite compliance with all duties of care and the application of technical standards.