FAQ Import of medicinal products

1. New Web Portal for the Submission of Applications or Notifications in Accordance with the Austrian Medicinal Products Import Act

The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) hereby informs you that, as of 4 July 2011, applications and notifications in accordance with the Austrian Medicinal Products Import Act (Arzneiwareneinfuhrgesetz, AWEG), Federal Gazette I No. 79/2010, are to be submitted electronically via a web portal.

The web portal can be accessed here.

Please note that organisations have to register with the BASG before first using the web portal. During registration, the BASG will check whether the registering organisation is authorised to submit applications or notifications in accordance with AWEG Articles 4 and 13. 

After successful registration, the organisation is provided with a user name and password enabling administrative access to the web portal  log in.

The administrator is then free to create and maintain additional users.

For more information on how to register, maintain your user data, and work with the new web portal, please go to faq about eservices.

The following documents also provide additional information on how to register for and use the web portal:

  • Guidance on Registering an Organisation; this document is addressed to organisations required to register.
  • Guidance on Maintaining Users and User Rights; this document is addressed to web portal administrators.
  • Handbook on Electronically Submitting Applications and Notifications in Accordance with the Austrian Medicinal Products Import Act 2010; this document is addressed to any member of an organisation submitting applications or notifications in accordance with the Austrian Medicinal Products Import Act.

The web portal and the accompanying documentation are currently available in German only; translation into English is planned.

2. Who is in charge of procedures related to the importation of medicinal products?

Responsible for importations of medicinal products into Austria is

Institute Surveillance

BASG

Traisengasse 5  - 1200 Vienna, Austria

 Contacts:

Dr. Elisabeth Bernhardelisabeth.bernhardagesat+43(0)50 555-36434
Dr. Gerhard Schielgerhard.schielagesat+43(0)50 555-36422

3. Who is entitled to submit import notifications or file applications for import licenses?

In accordance with the Austrian Medicinal Products Importation Act (Arzneiwareneinfuhrgesetz, AWEG), Federal Gazette No. 79/2010, the right to submit import notifications or applications for import licenses is limited to:

  • public pharmacies or
  • hospital pharmacies or
  • companies holding a license for the distribution of medicinal products or blood products in any of the contracting parties to the European Economic Area (EEA)

When filing an application for an import certificate or a certificate of marketability, companies from a member state of the EEA have to submit convincing evidence of their national license in accordance with the applicable medicines legislation.
When submitting an import notification, the Federal Office for Safety in Health Care (BASG) / Austrian Medicines and Medical Devices Agency (AGES) will determine whether the notifying party or applicant holds such a license.

A Clinical Research Organization (CRO) may not submit a transport notification or file an application for an import certificate or a certificate of marketability unless it holds a license for the sale of medicinal products.

Private individuals are not entitled to submit an import notification or apply for an import certificate or a certificate of marketability. For more information on the importation of medicinal products by private individuals, see the respective FAQ section.

4. We intend to import, from a third country/an EU member state, a medicinal product which is not licensed in Austria and contains a narcotic substance using a prescription/hospital pharmacy order. In accordance with the Medicinal Products Importation Act

The provisions of the Medicinal Products Importation Act (AWEG) apply (i.e., an import license issued by the Federal Office for Safety in Health Care (BASG) is required). Beyond that, the trade in narcotic drugs and psychotropic substances falls within the remit of the Federal Ministry of Health. Therefore, in addition to the import license issued by BASG, an import license for medicinal products containing narcotic or psychotropic substances must be applied for. For more information, please refer to the website of the Austrian Federal Ministry of Health www.bmg.gv.at.

5. Wholesalers/importers of veterinary medicinal products are said to be allowed to create small stocks of products to avoid bottlenecks in the supply of repeatedly ordered products. What is the status quo and which medicinal products may be held in stock

Wholesalers are permitted to create a stock of immunological preparations required on a recurring basis to enable them to fill these repeat orders. Such stocks can be filled using a single import license. What is required is an expert opinion issued by a veterinary surgeon, which has to be attached to the application. Creating such stocks is possible and, to the knowledge of the authorities, has become practice.

6. Examples of unauthorised recipients in accordance with Art 57 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG)

Art 57 para 1 AMG lists those parties entitled to procure medicinal products from manufacturers, distributors, or wholesalers of medicinal products.
The following are examples of unauthorised procurement of medicinal products.
Medicinal products depots in hospitals are a special form of storing medicinal products in hospitals without a dedicated hospital pharmacy. Such depots are subject to the supervision of a consulting public pharmacy or a consulting hospital pharmacy within the same hospital association (Krankenanstaltenverbund, KAV).

Blood and tissue products are the only products that may be delivered directly to hospitals without hospital pharmacies (Art 57 para 2 AMG). In the case of medicinal products complementing the medicinal products requirements of such hospitals, manufacturers, distributors, or medicinal products wholesalers may only deliver such products through pharmacies, ideally the responsible consulting pharmacy. Medicinal products are deemed delivered through a pharmacy when purchase orders are placed or billing is effected by this pharmacy.

Commercial wholesalers of medicinal products: Wholesalers of medicinal products holding a commercial license in accordance with Art 116 of the Austrian Trade and Commerce Regulation Act (Gewerbeordnung) are permitted to act as medicinal products wholesalers only if they are licensed to do so in accordance with Art 63 AMG, as specified in Art 2 para 2 AMG. For example, this means that pharmacies functioning not only as public pharmacies but also as wholesalers require a license in accordance with Art 63 AMG, even if their wholesaler’s license serves the sole purpose of supplying the procured medicinal products to their own pharmacy.

Doctors’ dispensaries: In accordance with Art 57 para (1)(1) AMG, doctors’ dispensaries may procure the medicinal products they dispense only through a pharmacy, but not straight from the manufacturer, distributor, of wholesaler. The medicinal products are deemed procured through a pharmacy when they are delivered under the immediate supervision of the responsible pharmacist of the supplying pharmacy and billing is effected through this pharmacy.

7. In cases of doubt, who decides whether an application for an import license or a certificate of marketability is required?

The scope of the AWEG is controlled by way of the customs tariff nomenclature. For goods imported from third countries, this control mechanism relies on the competence of customs authorities, who, upon import of the goods, have to release these good into free circulation within the Community.

A prerequisite for the release of goods is that they have been correctly classified in accordance with the customs tariff nomenclature and that they are accompanied by an import certificate or certificate of marketability issued by BASG.

Questions regarding the classification of goods in accordance with the Community customs tariff should be addressed to the Federal Ministry of Finance (Central Customs Tariff Information Centre, Zentrale Zollauskunftsstelle), who will provide a binding answer. BASG cannot provide any information on the classification of goods in accordance with the Community customs tariff on the grounds of lack of competence. In cases of doubt, please refer to the customs authorities. Do not apply for an import license or certificate of marketability with BASG before all of your tariff questions have been answered.

For more information, please go to the Central Customs Tariff Information Centre.

8. Who is obliged to submit a shipment declaration in accordance with AWEG?

Pursuant to Sections 6 (1), 14 (1) and 7 AWEG, the introduction of medicinal products or blood products authorised or manufactured in a contracting party to the EEA requires notification in accordance with Section 3 AWEG. Transport" (Section 2 no. 5 AWEG) is to be regarded as the event in the course of which the goods are physically delivered from abroad to the territory of the Federal Republic of Germany to an initial consignee. The reporting obligation applies to the first recipient. If the notification is not made by the latter, he must ensure (and prove accordingly) that the notification is made by the ordering pharmacy or that there is an exception. It is therefore the importing wholesaler and not the pharmacy that has to ensure that the notification is made.

9. What is covered by 'small imports' of proprietary medicinal products under Paragraph 11(1)(7) of the Arzneiwareneinfuhrgesetz?

The BASG stipulates that this is only permissible if the requirements in accordance with § 11 paras. 3 to 5 Medicinal Products Import Act are met.Accordingly, the introduction of proprietary medicinal products from an EEA State by an Austrian public pharmacy - without notification to the Federal Office for Safety in Health Care - is only possible if it is:- the proprietary medicinal product is lawfully on the market in the country of origin of the EEA - it is a medicinal product for human use - the proprietary medicinal product is intended to be passed on to certain persons for their personal use (there must be a specific order in the pharmacy for a patient who is identified at the time of ordering)the quantity intended for that person does not exceed three commercial packages of a medicinal speciality intended for supply to private individuals - if the medicinal speciality is subject to prescription in the country of origin of the EEA, a medical or dental prescription must be produced pursuant to Paragraph 11(1) of the Act. 5 Arzneiwareneinführgesetz (Medicines Import Act), the public pharmacy has to inform the public about the purchase within the framework of the "small import" pursuant to para. 1 Z 7 Medicinal Products Import Act, which must contain precise documentation of the order process as well as at least the following information:- Name of the proprietary medicinal product- Number of commercial packages indicating the package sizes- Contracting Party of the EEA from which the proprietary medicinal product was sourced and the supplying firm located there-Price at which the proprietary medicinal product was obtained - recipient of the proprietary medicinal product - name and professional address of the prescribing doctor or dentist, where appropriate

The BASG provides the document F_I561 for the documentation according to § 11 Abs. 5 Arzneiwareneinfuhrgesetz.

These records must be kept at the pharmacy for at least five years and made available for inspection by the Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen).

10. How are site-specific vaccines to be reported?

The movement of a herd specific vaccine or autovaccine produced in an EEA Member State by an undertaking holding a manufacturing authorisation issued by the competent national authority shall be subject to notification in accordance with Article 6(1) AWEG. The notification must reach the BASG electronically no later than 2 months after the shipment. The veterinary statement of requirements for the whole quantity and the instructions for use issued for each batch shall be attached to the notification.

11. As a (hospital) pharmacy, I have a need for medicinal products which are neither authorised in Austria nor in the EEA. It is not possible to procure the necessary supplies for the treatment of the patient on a case-by-case basis. How can a uU resul

The timely availability of medicinal products not authorised in Austria or in the EEA can be guaranteed without difficulty under the following conditions:

  1. The probable recurring need is demonstrably given
  2. Application for an import certificate with hospital requirement (not at patient level)
  3. In case of need, it is exclusively and comprehensibly handed over to (specifically) certain patients only
  4. Medicines that are not required during their lifetime are disposed of in a documented manner.

The basic requirements regarding the import of medicinal products must be observed.

12. Does a centrally authorised medicinal product have to be notified to the BASG if it is shipped from another Member State?

For a centrally approved medicinal speciality, no notification to the BASG is necessary for shipments from another member state due to the exemption provision pursuant to § 11 Para. 1 No. 1 AWEG, provided that the labelling fulfils the Austrian requirements.

Sections 3 to 10 of the AWEG do not apply to medicinal specialities which are imported or transferred and for which it is proven that they have been imported in accordance with Section 7 of the Medicines Act or in accordance with Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use, or registered in accordance with Section 27 of the Medicines Act or authorised for parallel import distribution in accordance with Section 10c of the Medicines Act.

13. Are active substances subject to the Arzneiwarenimfuhrgesetz?

Active substances are not covered by the Medicinal Products Import Act. The specific requirements regarding their importation for medicinal products for human use can be found in § 4b AMBO 2009, available here.

14. The application of the provisions of the 2010 Medicinal Products Import Act (AWEG) in the event of imminent supply shortages

According to § 7 para. 1 of the Austrian Medicines Act (AMG), medicinal products may only be supplied or kept ready for supply in Austria if they have been licenced by the BASG, unless they are

  1. medicinal products centrally licenced in accordance with Regulation (EC) No 726/2004, Regulation (EC) No 726/2004 in conjunction with Regulation (EC) No 1901/2006, or Regulation (EC) No 1394/2007
  2. medicinal products the introduction or importation of which takes place in accordance with the Austrian Medicines Import Act 2010 (AWEG), Federal Law Gazette I No 79/2010, or
  3. medicinal products for which a licence has been granted under Article 12 of the law on epizootic diseases (Tierseuchengesetz), RGBl. No 177/1909

Information on alternatives

If a supply shortage is foreseeable, the marketing authorisation holder can inform his customers at an early stage about the imminent supply shortage and about alternatives (sometimes from his own product range). If the alternatives are not licenced in Austria, they must be brought into Austria by the Austrian Medicines Import Act 2010 (AWEG 2010). Only the treating physician decides on the potential use of the offered alternative.

Procurement abroad only on doctor's request

If a medicinal product is not available in Austria, there is the possibility to bring a medicinal product not licenced in Austria to Austria by means of the AWEG 2010. If this proprietary medicinal product is required for human or animal use for medical, dental, veterinary or scientific purposes, it must either be intended for the performance of clinical or non-clinical tests or clinical trials or for medical, dental or veterinary trea-tment because the success of the treatment is unlikely to be achieved with a proprietary medicinal product licenced and available in Austria.

Time of procurement abroad

If the medicinal product is used for medical, dental or veterinary treatment, it may be shipped to Austria and kept ready for distribution within Austria as soon as a product is no longer available in Austria and a medical expert opinion confirms that, according to §5 para. 2 lit. 2 AWEG 2010, the success of the treat-ment is unlikely to be achieved with a medicinal product that is licensed and available in Austria. The medical expert opinion must be prepared without reference to the patient.

Date of submission of the import notification

In the case of medicinal products pursuant to § 2 para. 1 AWEG 2010 which have been licenced or manu-factured as proprietary medicinal products in a contracting party of the EEA and in the case of medicinal blood products licenced as proprietary medicinal products in a contracting party of the EEA pursuant to § 2 para. 2 AWEG 2010, notification is required at the latest two months after the shipment (§ 6 para. 3 and § 14 para. 7 AWEG 2010). The notification to the BASG is not a prerequisite for the shipment of medicinal or medicinal blood products. The products can be shipped and made available to the treating physicians if a medical expert opinion is available. The notification must be submitted to the BASG within 2 months of the shipment.
In the case of immunological specialities for human medicinal use according to § 7 AWEG 2010, the notifi-cation must be made before the products are brought into Austria, and the BASG must be informed at the same time as the notification. The BASG reacts immediately and informs in writing whether there is an ob-jection to the shipment. The shipment can then be carried out. The same applies to immunological veteri-nary medicinal products according to § 8 AWEG 2010 and to veterinary medicinal products according to 9 AWEG 2010.
For the benefit of the patient, the Austrian Instructions for Use (Package Leaflet) should be enclosed whenever possible. The packaging must not be damaged.

Notification of centrally authorised proprietary medicinal products

According to Regulation (EC) No. 726/2004, centrally authorised products are subject to the notification obligation as described above under AWEG 2010 if they are not to be placed on the market in Austria in the labelling intended for Austria, and can be shipped and made available to the treating physicians at the latest 2 months after shipment, if a medical expert opinion is available.

End of a shortage

At the end of a supply shortage, the conditions for the domestic levy to avoid a supply shortage are no longer fulfilled.

Serialisation

Medicinal products serialised in a contracting party of the EEA can also be read out in Austria with the non-Austrian serial number and booked out via the EU-HUB in the country of origin.
If a non-serialised medicinal product is lawfully marketed in another EEA country, it does not need to be serialised in order to be marketed in Austria via AWEG 2010.
Non-serialised proprietary medicinal products from a third country cannot be booked out in Austria, but may still be imported.

(Status: December 12, 2019)

15. Under what circumstances may a medicinal product be imported for a named patient use (§ 8 para. 1 lit. 2 Austrian Medicines Act)?

The provisions on the named patient use are only applicable if an acute health emergency exists for a patient already known by name at the time of the order and the medicinal product concerned is urgently needed to prevent a life-threatening or seriously damaging health condition and this success can probably not be achieved with an approved and available medicinal product according to the state of the art. This must be demonstrated to customs by the importer based on an appropriate medical expert opinion, as the need must be covered without undue delay (Note: the data protection provisions apply to the name of the patient). The import constitutes an exception to the Medicinal Products Importation Act (Arzneiwareneinfuhrgesetz, AWEG 2010). Such import / shipment constitutes an exception to the Import of Medicinal Products Act. The BASG is not to be involved, but the plausibility of the fulfilment of the requirements for the urgent therapeutic need can be verified subsequently.

If the need is foreseeable, but can be planned (because no specific patients are being treated at the time of ordering), the provisions of the Medicinal Products Importation Act (in the sense of § 5 para. 2 lit. 2 AWEG) apply, according to which an application for the issue of an import license or a notification of shipment is required, accompanied by a request for a clinic.

Further information on the delineation of the named patient use by the Medicinal Products Importation Act and Compassionate Use can be found in "Information on the („Named Patient Use“) in Austria".

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