Importation of medicinal products

Importation of medicinal product and blood derivates to Austria

Reference to the overview publication on the subject.

 

Legal basis: AWEG Arzneiwareneinfuhrgesetz 2010

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 under the following address:
http://www.basg.gv.at/en/ages-eservices/


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: http://www.basg.gv.at/en/ages-eservices/faq/


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.

    1. 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 / AGES Medicines and Medical Devices Agency

    Traisengasse 5  - 1200 Vienna, Austria

     

     Contacts:

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

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. Bei wem liegt die Verpflichtung zur Abgabe einer Verbringungsmeldung nach AWEG?

    Gemäß den §§ 6 Abs. 1, 14 Abs. 1 und 7 AWEG bedarf das Verbringen von in einer Vertragspartei des EWR zugelassenen oder hergestellten Arzneiware oder einem  Blutprodukt einer Meldung gemäß § 3 AWEG.  Die "Beförderung" (§ 2 Z 5 AWEG) ist als das Ereignis zu betrachten, im Zuge dessen die Ware physisch aus dem Ausland in das Bundesgebiet an einen Erstempfänger geliefert wird. Die Meldeverpflichtung trifft den Erstempfänger. Sollte die Meldung nicht durch diesen erfolgen, hat er sicherzustellen (und dementsprechend nachzuweisen), dass die Meldung durch die bestellende Apotheke erfolgt oder ggf. eine Ausnahmebestimmung vorliegt. Es ist daher der importierende Arzneimittelgroßhändler und nicht die beauftragende Apotheke, der sicherzustellen hat, dass die Meldung abgegeben wird.

    8. Was fällt unter "Kleinimport" von Arzneispezialitäten gemäß § 11 Abs. 1 Z 7 Arzneiwareneinfuhrgesetz?

    Das BASG hält fest, dass dieser nur unter Einhaltung der Anforderungen gemäß § 11 Abs. 3 bis 5 Arzneiwareneinfuhrgesetz zulässig ist.

    Demnach ist das Verbringen von Arzneispezialitäten aus einem EWR-Staat durch eine österreichische öffentliche Apotheke - ohne Meldung an das Bundesamt für Sicherheit im Gesundheitswesen - nur möglich wenn:

    ·    die Arzneispezialität im EWR-Herkunftsland rechtmäßig in Verkehr ist
    ·    es sich um eine Humanarzneispezialität handelt
    ·    die Arzneispezialität zur Weitergabe an bestimmte Personen für deren persönlichen Bedarf bestimmt ist (es muss eine konkrete Bestellung für einen bei Bestellung feststehenden Patienten in der Apotheke vorliegen)
    ·    die für diese Person bestimmte Menge drei für die Abgabe an Privatpersonen vorgesehene Handelspackungen einer Arzneispezialität nicht übersteigt
    ·    falls die Arzneispezialität im EWR-Herkunftsland der Rezeptpflicht unterliegt, ist eine ärztliche oder zahnärztliche Verschreibung vorzulegen

    Gemäß § 11 Abs. 5 Arzneiwareneinführgesetz hat die öffentliche Apotheke über den Bezug im Rahmen des „Kleinimports“ gemäß Abs. 1 Z 7 Arzneiwareneinfuhrgesetz Aufzeichnungen zu führen, die eine genaue Dokumentation der Abwicklung des Bestellvorganges sowie zumindest folgende Angaben enthalten müssen:

    ·    Bezeichnung der Arzneispezialität
    ·    Anzahl der Handelspackungen unter Angabe der Packungsgrößen
    ·    Vertragspartei des EWR, aus dem die Arzneispezialität bezogen wurde, und die dort ansässige Lieferfirma
    ·    Preis, zu dem die Arzneispezialität bezogen wurde
    ·    Empfänger der Arzneispezialität
    ·    gegebenenfalls Name und Berufssitz des verschreibenden Arztes oder Zahnarztes

    Diese Aufzeichnungen sind zumindest fünf Jahre im Apothekenbetrieb aufzubewahren und für eine Überprüfung durch das Bundesamt für Sicherheit im Gesundheitswesen bereitzuhalten.

    Das Verbringen von Humanarzneispezialitäten im Rahmen des "Kleinimports", ohne dass bereits zum Zeitpunkt der Bestellung ein konkreter Bezug auf einen Patienten in der Apotheke vorliegt ist somit rechtswidrig.

    9. Wie sind bestandsspezifische Vakzine zu melden?

    Die Verbringung einer Bestandsspezifischen Vakzine oder Autovakzine, die in einem EWR-Mitgliedsstaat durch ein Unternehmen, das über eine Herstellerlaubnis der zuständigen nationalen Behörde verfügt,  hergestellt wurde, bedarf einer Meldung gemäß § 6 Abs. 1 AWEG. Die Meldung muss bis spätestens 2 Monate nach der Verbringung auf elektronischem Weg beim BASG einlangen. Die tierärztliche Bedarfsbescheinigung über die gesamte Menge sowie die, für die jeweilige Charge ausgestellte, Gebrauchsinformation sind der Meldung beizufügen.

    Created: 12.04.2009 | Page last modified: 22.05.2017

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