FAQ BASG-All-in-One Register

1. Which registers are included in the BASG All-in-One Register?

  • Medicinal product index
  • Shortages index
  • BASG announcements
  • BASG votes

2. In which languages is the BASG All-in-One Register available?

The BASG All-in-One Register can be used in German and English.

3. How often is the data in the BASG All-in-One Register updated?

The data is updated once a day. The time of the last update can be seen in the BASG All-in-One Register in the search area.

4. Can I search using wildcards?

Yes, you can use * to optimise your search in text fields.

If *

  • is specified before the search value, hits are returned in which the search value appears somewhere in the name.
  • specified after the search value, results are returned that begin with the search value.
  • if * is used more than once, results can be restricted even more specifically and both search options can be combined.

5. General information on the Medicinal Product Index

Legal basis: Ordinance of the Federal Minister of Health on the Austrian Medicinal Product Index 2013.

The details of all medicinal products authorised/registered in Austria can be searched using the “Online search for registered medicinal products”.
You can search for several terms and thus determine the scope of the results data.

For medicinal products that have been authorised centrally - recognisable by the authorisation number beginning with EU/.. - the corresponding information can be found on the website of the EMA (European Medicines Agency).

6. What data is displayed in the hit list of the medicinal product index?

  • Name: Name of the medicinal product in accordance with Section 1(4)(14) of the Austrian Medicinal Products Act (AMG).
  • Active substance(s): Medicinally active ingredients according to Section 1 paragraph 4 number 4a of the Austrian Medicinal Products Act (AMG).
  • Package leaflet: Currently valid Package leaflet in accordance with Section 16 of the Austrian Medicinal Products Act (AMG) (only displayed for national marketing authorisations and can be viewed/downloaded).
  • Holder: Name of the holder a marketing authorisation/registration or authorisation of the parallel import, in accordance with Section 2 (13a) of the Austrian Medicinal Products Act (AMG).
  • Prescription required: Indication of whether a medicine is prescription-only or not (more information on prescription status can be found in the detailed view of the selected medicine).

7. What data is displayed in the ‘Details’ tab of the detailed view of the register of proprietary medicinal products?

  • Name: Name of the medicinal speciality in accordance with Section 1 paragraph 4 number 14 of the Austrian Medicinal Products Act (AMG).
  • Active substance(s): Medicinally active ingredients in accordance with Section 1 paragraph 4 number 4a of the Austrian Medicinal Products Act (AMG). If a medicinal product contains several active ingredients, these are separated by the separator ‘I’.
  • ATC code: Anatomical Therapeutic Chemical Classification according to WHO (World Health Organization).
  • Prescription status: The prescription status determines whether a medicine must be prescribed by a doctor or whether it can be purchased from a pharmacy without a doctor's prescription. 
    Legal basis in the currently valid version: Medicinal Products Act (AMG), Compulsory Prescription Act, Compulsory Prescription Regulation, Narcotic Drug Act, Narcotic drugs decree, Psychotropic substances decree.
  • Supply status: Supply regulations according to Section 57 of the Medicinal Products Act (AMG).
  • Narcotic drug: Labelled with Yes if at least one active substance is subject to the Narcotic Drug Act.
  • Psychotropic: Labelled with Yes if at least one active substance is subject to the Psychotropic substances decree.
  • Holder: Name of the holder a marketing authorisation/registration or authorisation of the parallel import, in accordance with Section 2 paragraph 13a of the Austrian Medicinal Products Act (AMG).
  • Pharmaceutical dose form: Pharmaceutical form of a medicinal product.
  • Strength: Strength of a medicinal product.
  • Marketing cessation notified: Labelled with Yes if the BASG has been notified of a temporary or permanent cessation of placing on the market in accordance with Section 21 paragraph 2 of the Austrian Medicines Act (AMG).
  • MR/DC/CP number: Product-related number consisting of the country code of the Reference Member State, the domain (human or veterinary), the product number and the strength number, e.g. AT/H/1234/001. In the case of centralised marketing authorisations, the EMA ‘core number’ is displayed, e.g. EMEA/H/C/xxxxxx.
  • Authorisation number: Unique number for the medicinal product that is assigned upon authorisation and remains identical throughout its life. Authorisation numbers beginning with EU indicate centrally authorised medicinal products.
  • Authorisation date: Date on which the authorisation/registration was granted.
  • Drug category: Category of a medicinal product.
  • Vaccine: Labelled with Yes if the medicinal product is a vaccine.
  • Allergen: Labelled with Yes if the medicinal product is an allergen product.
  • Additional monitoring: The European Union has introduced labelling for medicinal products that are additionally - i.e. particularly closely - monitored. These medicinal products are labelled in the Information for healthcare professionals and in the package leaflet (formerly package insert) with a black triangle ▼ standing on its tip. See also https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/faq-marketing-authorisation-life-cycle/black-triangle
  • Mandatory for batch release?: Restriction for the batch release obligation in accordance with Section 26 paragraph 1 of the Austrian Medicinal Products Act (AMG). see also www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/faq-marketing-authorisation-life-cycle/batch-release.
  • Exception for batch release?: Restriction for an exemption from batch release in accordance with Section 26 paragraph 4 of the Austrian Medicines Act (AMG). see also https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/faq-marketing-authorisation-life-cycle/batch-release.
  • Authorised in Liechtenstein?: Medicinal product authorised in accordance with BGBl. III Nr. 126/2010 (Agreement between the Austrian Federal Government and the Government of the Principality of Liechtenstein concerning the automatic recognition of human and veterinary medicinal products authorised or registered in Austria in Liechtenstein).
  • EU databases:
    - Documents on centrally authorised proprietary medicinal products can be found on the website of the European Commission.
    - Information on existing parallel distributions can be found at https://iris.ema.europa.eu/registerpd/.
    - Further information on medicinal products that have been authorised under the mutual recognition procedure (MRP) or decentralised    authorisation procedure (DCP) can be found in the Mutual Recognition Index (MRI). Enter the value from the MR/DC/CP number column in  the ‘Search’ field at the top right, e.g. AT/H/1234/001. Attention: no EMA ‘core number’ allowed.
    - Further information on veterinary medicinal products (veterinary medicinal specialities) can also be found on the website of the European Union.
  • Domain: Indication of whether the medicinal product has been authorised for humans or animals.
  • Animal species: For veterinary medicinal products is indicated in each case:
     - Route of administration
     - Dosage
     - Tissue
     - Withdrawal Period: <waiting time> <unit>
     - Comment

8. Which documents are displayed in the "Documents" tab in the detailed view of the register of proprietary medicinal products?

For national marketing authorisations, the following documents are listed and can be displayed/downloaded if they are available:

  • Package leaflet (national translation)
  • Summary of Product Characteristics: SmPC (national translation)
  • Public Assessment Report (PAR)
  • Risk Management Plan (RMP Summary)

According to Art 27 AMG the Austrian Medicinal Product Index is published by BASG (Federal Office for Safety in Health Care) where defined data of all authorised and registered medicinal product including their product informations (SmPC and PL) can be found.

In addition, the national public assessment report (PAR), which is derived from the assessment during the evaluation process, is made available to the public after deletion of commercially confidential information.

PARs of European evaluation processes (MR/DC or centralised) are published in English, those of national procedures in German.

  • If Austria is concerned member state, a link to the Mutual Recognition Index is published. The maintenance of this publication is the responsibility of the RMS.
  • If the medicinal product is authorised in a centralised procedure, a link to the European Medicine Agency's website is published. The maintenance of this publication is the responsibility of the EMA.

9. Why are no instructions for use (IFU) and summary of product characteristics (SmPC) linked for centrally authorised products?

The valid Package leaflet and Summary of Product Characteristics (SmPC) are available in EMA databases.
The ‘Community Register’ is stored as a hyperlink and links to the following URL: http://ec.europa.eu/health/documents/community-register/html
A corresponding search can be carried out there if the hyperlink does not lead directly to the product page.

The Package leaflet and Summary of Product Characteristics (SmPC) can be downloaded individually in chronological order in the ‘Annexes’ section.

10. Can results from the register of proprietary medicinal products be exported?

The hit list can be downloaded as .xls or .csv via the download-button.
Note: This function will be available in the future.

11. Distribution restrictions register (general register)

All reported procedures are presented in the "Shortages index" - it is therefore the common register. Notifications concerning prescription-only medicines are checked by the BASG before publication.

Not included are notifications pursuant to Section 21 (2) of the Austrian Medicines Act as amended.

The notifications are automatically published in the "Shortages index" on the following day from the actual start of the shortage.

The reporters are responsible for the accuracy of the data. The BASG does not have information on existing stocks in the distribution chain (i.e. wholesalers, pharmacies).

12. What can I search for?

You can search by name or authorisation number. Alternatively, you can search by active substance (INN and synonyms). Further restrictions can be achieved with the search fields in the advanced search area.

13. What data is displayed in the hit list of the sales restriction register?

  • Name: Name of the medicinal speciality in accordance with Section 1 paragraph 4 number 14 of the Austrian Medicinal Products Act (AMG).
  • Active substance(s): Medicinally active ingredients according to Section 1 paragraph 4 number 4a of the Austrian Medicines Act (AMG).
  • Status:
  • Date of report.
  • Applicant.

14. What data is displayed in the ‘Sales restriction’ tab in the detailed view?

  • Active substance(s): Medicinally active ingredients in accordance with Section 1 paragraph 4 number 4a of the Austrian Medicinal Products Act (AMG).
  • Strength: Strength of a medicinal product.
  • Pharmaceutical dose form: Pharmaceutical form of a medicinal product.
  • Domain: Indication of whether the medicinal product has been authorised for humans or animals.
  • ATC code: Anatomical Therapeutic Chemical Classification according to WHO (World Health Organization).
  • Reason
  • Holder: Name of the holder of the marketing authorisation/registration or authorisation of the parallel import, according to Section 2 paragraph 13a of the Austrian Medicines Act (AMG).
  • Telephone number of holder
  • MA number: Unique number for the medicinal product that is assigned upon authorisation and remains identical throughout its life. Authorisation numbers beginning with EU identify centrally authorised medicinal products.
  • Important BASG-information
  • Information letter to healthcare professionals
  • Last modification date
  • Date of report
  • Legal basis of the notification
  • Export ban
  • Availability of packs

15. Can results from the distribution restriction register be exported?

The hit list can be downloaded as .xls or .csv via the download-button.
Note: This function will be available in the future.

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Further inquiry note