Import of medicines

Import of pharmaceutical products - electronic submission

Attachment according to the Arzneiwareneinfuhrgesetz (AWEG), BGBl I Nr. 79/2010, must be done electronically.

Applications and notifications can be submitted via the BASG online service platform.

Detailed information is available in the FAQs.

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Import and shipment of pharmaceuticals and blood products to Austria

The import and shipment of pharmaceuticals and blood products to Austria are regulated by the Austrian Medicines Import Act (AWEG). The scope of the law is determined by the uniform European customs tariff nomenclature and covers those goods through customs tariff numbers which are listed in the customs tariff under the terms 'medicinal product' and 'blood product'. The Austrian Federal Office for Safety in Health Care (BASG) is responsible for processing applications and handling notifications within the scope of the AWEG.

The term medicinal product

The term medicinal product is taken from the Community Customs Tariff (TARIC), the legal basis of which is Regulation (EEC) No 2658/87. According to TARIC, 'medicaments' are pharmaceutical products consisting of mixed or unmixed products for therapeutic or prophylactic purposes, dosed or put up for retail sale. The term 'medicinal product' covers only finished specialities and bulk goods (Note: Bulk goods according to § 2 para. 3a Medicines Act are any substance or preparation of substances according to § 1 para. 1 AWEG, which only have to be filled or packaged to become the final product). Intermediates or active substances are not covered by the term 'medicaments' and are not covered by the AWEG.

The term blood product

The term 'blood products' includes the two TARIC headings 3002 9010 'Human blood' and 3002 10 'Antisera and other blood fractions and modified immunological products, including those produced by a biotechnological process'. Blood products are not restricted to certain production stages. The AWEG covers starting materials and intermediate stages of the entire production chain as well as medicinal specialities for this product group.

The terms import and shipment

The terms 'import' and 'shipment' enable a clear linguistic distinction to be made between flows of goods from third countries (import according to § 2 lit. 4 AWEG) and those from contracting parties of the European Economic Area (EEA) (shipment according to § 2 lit. 5 AWEG). The BASG is authorized to inspect the entire process of shipment and import by requesting documents or by on-site inspection (§ 20 AWEG). In the case of inspection activities, it accesses documents which must be available to the declarants or applicants in order to fulfil the obligation to provide evidence. In the case of goods purchased from third countries, customs must release the goods for intra-Community trade on presentation of an import certificate or a certificate of marketability issued by the BASG. Demarcation questions concerning the classification of products according to the Community Customs Tariff shall be addressed to the central customs information office. Medicinal specialities that are needed in an acute emergency to urgently avert serious damage to health or a danger to life are not subject to the AWEG. Such products may also be transported without authorisation on the basis of a medical certificate (technical justification as to why the success of treatment with an authorised and available medicinal product is unlikely to be achieved according to the state of the art; in this case a prescription is not sufficient) or - in the case of import - collected from customs. Even centrally approved products are not subject to the AWEG (§ 7 Abs. 1 lit. 1 AMG).

The submission of applications and notifications

Applications and notifications must be submitted in electronic form in accordance with the Electronic Submission Ordinance 2011 (EEVO 2011). The use of the electronic portal requires prior registration, authorization checks and the assignment of a user ID. Access is available under Online Services.

Permissions

The right to submit an application or a notification is limited to public pharmacies, institutional pharmacies and companies which are entitled to sell pharmaceutical products in a contracting party to the EEA (Section 4 (1) AWEG). In addition, veterinarians in charge of pharmacies may report the movement of veterinary specialities for their own consumption (§ 4 para. 4 AWEG).

There is no restriction on the territory of Austria for companies authorised to distribute pharmaceutical products. Clinical Research Organizations (CROs) are only regarded as companies that are entitled to sell pharmaceutical products in a contracting party of the EEA if they have a licence in accordance with § 63 AMG or have the equivalent authority of a member state.

Conditions for import or shipment

Medicinal products may only be imported or brought into Austria if they are intended for re-export or use on humans or animals or for scientific purposes with or without use on humans or animals (§ 5 para. 1 AWEG).

For the safety of blood products (§ 15 AWEG), all relevant Austrian provisions of the AMG, Directive 2001/83/EC, Blood Safety Act (BSG), Blood Donor Regulation (BSV) and the Blood Products Regulation in conjunction with Directive 2002/98/EC in their current versions apply.

In addition, medicinal products are subject to the restriction that they may only be imported or transferred for clinical trials or therapeutic purposes. Two conditions are linked to the therapeutic purpose: the lack of availability in Austria of an authorised medicinal speciality authorised for therapeutic purposes and a medical opinion certifying the absolute necessity of the medicinal speciality to be imported or transferred being required for medical, dental or veterinary treatment because the success of the treatment is unlikely to be achieved with a (different) medicinal speciality authorised and available in Austria. This opinion must contain a technical justification, the submission of a prescription is not sufficient. The names of the patients to be treated do not have to be mentioned in the expert opinion.

The authorisation procedure for products from third countries

The licensing procedure is applied when pharmaceutical products (§ 5 AWEG) or blood products (§ 12 AWEG) are imported into Austria from third countries. The necessary authorisations must be applied for and issued before the intended importation. Medicinal products subject to authorisation require an import certificate. Such goods can be: Medicinal specialities for human or veterinary therapy, (non-)clinical investigational medicinal products, bulk goods, medicaments for analytical purposes or medicaments for destruction. Blood products subject to authorisation require a certificate of marketability. Such goods can be: Medicinal specialities, starting materials, intermediates or reagents and diagnostics.

Imports of unfinished products from third countries

  • Medicinal products (bulk goods; § 5 para. 1 lit. 1 and 3 AWEG)

Bulk goods imported from a third country must meet the requirements of Art. 51 Directive 2001/83/EC or § 3 Para. 2 of the German Drug Administration Regulations (AMBO). The BASG may require any proof required to prove the lawfulness of production and pharmaceutical quality. If the bulk goods are intended for the manufacture of a proprietary medicinal product which is to be marketed in Austria or in another EEA country, the bulk goods must meet the requirements of the marketing authorisation for the finished product (Article 51 of Directive 2001/83/EC and Paragraph 3(2) of the AMBO). If the bulk goods are intended for the manufacture of a product to be placed on the market in a third country, the evidence shall be limited to the legality of the manufacture in the country of origin and, if necessary, to proper transport. Medicinal specialities completely manufactured in a third country and approved in Austria are not subject to the AWEG.

  • Blood products (starting material and intermediate products, § 12 AWEG)

The two TARIC positions listed in the AWEG are broader than the definition in Directive 2001/83/EC and therefore include all products of Art. 1 lit. 10. In addition to the legal requirements described for medicinal products, § 4 of the Blood Products Regulation applies to blood products from third countries. Such blood products must therefore have a Plasma Master File (PMF) certified by the competent Austrian Federal Ministry, the European Medicines Agency (EMA) or the competent authority of another Party to the EEA Agreement.

In addition to the legal requirements, controlled and verifiable storage conditions must be observed for raw materials and intermediate products in accordance with their nature, which cover every storage and transport step that is carried out during transport.

Imports of finished products from third countries

  • Medicinal specialities for clinical trials

Medicinal products or blood products which are released by customs must be released by a qualified person, even if the goods are only transferred into the finished investigational product after their importation through a final manufacturing step (e.g. labelling). The manufacture of an investigational medicinal product in a third country must be at least equivalent to the European manufacturing standard (Article 13(3)(b) of Directive 2001/20/EC). Its composition must be in conformity with the licensing application submitted to the licensing authority (Section 40 AMG or Art. 9 Par. 2 Directive 2001/20/EC). The same applies to investigational medicinal products intended for use as reference medicinal products (Art. 13 para. 3 lit. c Directive 2001/20/EC). When submitting an application, it must be possible to trace the assignment to a clinical trial. In addition, the application must be traceable to the releasing Qualified Person, the quantities applied for must correspond to the study protocol and must be documented by medical certificates of need (§ 5 para. 4 AWEG). If investigational medicinal products consist of blood components (in particular albumin, coagulation factors and immunoglobulins of human origin), § 4 of the Blood Products Regulation must be taken into account in addition to the above-mentioned requirements. Furthermore, such medicinal specialities are subject to batch release by a state testing laboratory (Official Medicines Control Laboratory [OMCL] of the BASG).

  • Medicinal specialities for patient-related therapy

Unauthorised medicinal specialities originating abroad may only be placed on the market if their import has been authorised or if their shipment has been reported (§ 7 para. 1 lit. 2 AMG).

There is an exception for medicinal specialities ordered by public pharmacies for their customers from abroad (§ 11 par. 1 fig. 7 in conjunction with § 11 par. 3, 4 and 5 AWEG). The pharmacy must keep precise records of such references, which must include precise documentation of the order process. A medical or dental prescription must be provided for the purchase of proprietary medicinal products which are subject to prescription in the EEA Party from which they are purchased.

The notification procedure for products from the EEA

The procedure generally applies to shipments of goods produced or authorised within the EEA. Goods shall be deemed to have been manufactured in the EEA if they have been released by a qualified person of a member state. Depending on the type of product, a preliminary or subsequent notification must be submitted. Prior notification gives the BASG the opportunity to intervene before goods can reach Austria.

Shipment of unfinished products from the EEA

For unfinished pharmaceuticals (bulk goods, § 6 para. 1 AWEG) from the EEA, the same purposes as for third country products apply. The deadline for submitting the notification shall be two months from the date of the shipment. Bulk goods manufactured in an EEA member state must meet the requirements of Art. 51 (1) Directive 2001/83/EC or § 3 (1) AMBO. This also applies to goods intended exclusively for export.

Blood products (starting material and intermediate products; Section 14 (1) AWEG) which are not authorised in a contracting party of the EEA but are manufactured there require a notification to be submitted three weeks before their shipment (Section 14 (1) AWEG). In addition to Directive 2001/83/EC in conjunction with Directive 2002/98/EC, the requirements of Section 3 of the Blood Products Ordinance apply to medicinal products containing human blood or manufactured from human blood. They may only be transported to Austria if the activities of the blood establishments in connection with the collection and testing of human blood have received the corresponding authorisation from the competent authority of the Member State (Art. 5 Directive 2002/98/EC) or if a certified PMF is available for the plasma used.

Shipment of finished products from the EEA

Medicinal products from the EEA are subject to the same purpose as third country products (§ 5 para. 2 lit. 1 and 2 AWEG).

  • Medicinal products for clinical trials

Investigational preparations for non-clinical or clinical trials manufactured in the EEA or Switzerland do not require notification (§ 6 para. 2 and § 14 para. 8 AWEG). It should be noted that investigational medicinal products manufactured using human blood or blood plasma are subject to batch release by the AGES OMCL pursuant to § 26 para. 1 lit. 1 AMG.

  • Medicinal products for therapy

The notification may be made two months after the shipment. In the case of blood products, the obligation to release batches in accordance with § 26 para. 1 lit. 1 AMG must be observed. If products which have already been in a member country are returned to Austria, complete and unambiguously assignable temperature records must be verified. The import or introduction of small quantities of blood products intended exclusively for quality control, analysis or scientific purposes - without application to humans - does not require a certificate of marketability or notification (§ 16 AWEG).

The notification of medicinal products is not a substitute for the provisions of parallel import pursuant to § 10c AMG.

Import and shipment of reagents and diagnostic medical devices

Reagents and diagnostics are only covered by the AWEG if they are not placed on the market as medical devices in accordance with the Medical Devices Act (MPG) or Directive 1998/79/EC (§ 1 para. 2 AWEG) and if they are to be subsumed under the customs tariff numbers 3006 30 or 3002 10.

Immunologicals

Immunological human medicinal products

According to § 7 AWEG, immunological human medicinal products can only be shipped to Austria if they are approved in a contracting party of the EEA and, in case of existing supply bottlenecks, are required for the implementation of vaccinations recommended in the Austrian vaccination plan. The shipment must be notified three weeks in advance. In addition, the provisions of batch release pursuant to § 26 AMG para. 1 lit. 2 must be observed.

Immunological veterinary medicinal products

The movement of an immunological veterinary medicinal product authorised in a Contracting Party of the EEA and required in the absence of a speciality authorised and available in Austria must be notified six weeks in advance (§ 8 AWEG). It should be noted that immunological veterinary medicinal products which are regulated in accordance with § 12 of the Animal Diseases Act (TSG) may only be introduced if they have been approved for use by the BMG. Immunological veterinary medicinal products against animal diseases other than those referred to in § 12 TSG may normally be moved without an authorisation for use provided they are authorised in the EEA. Excluded from the authorisation requirement are site-specific vaccines. Immunological veterinary medicinal products from third countries may generally only be imported in conjunction with a marketing authorisation issued by the competent Austrian Federal Ministry.

Veterinary medicinal products for veterinarians who operate their own pharmacies

Veterinarians in charge of pharmacies are allowed to declare veterinary medicinal products for their own use (§ 4 para 4 AWEG [1]) and to spend them if they are needed for therapeutic purposes and come from a member state of the EEA (§ 9 AWEG) or are licensed in a member state of the EEA and correspond to a veterinary medicinal product authorised in Austria. The notification must be made two weeks prior to shipment (Section 9 (4) AWEG).

The right of registration of veterinarians operating pharmacies only includes veterinary medicinal products which are pharmaceuticals, but not blood products.

Named Patient Use versus Compassionate Use

Differences in import determinations of medicinal products for named patient use versus compassionate use

If a physician requires a medicinal product for a Named Patient Use that is not approved in Austria, a distinction must be made:

  1. Unpredictable acute need of the medicinal product: If the medicinal product is needed unforeseeably and urgently for immediate defence against a life-threatening event or serious damage to health, the provisions of § 8 para 1 no. 2 AMG shall apply. Under these circumstances the Arzneiwareneinfuhrgesetz (AWEG) does not apply. A medical certificate of urgency can be used to collect the medicinal product from customs or to transport it (import certificate, certificate of marketability or movement declaration are not required). After the acute danger has been averted, the provisions of the Arzneiwareneinfuhrgesetz (AWEG - Austrian Medicinal Products Import Act) must be complied with in the event of further requirements.
  2. Plannable need for the medicinal product: If the success of the treatment cannot be expected with a medicinal product approved and available in Austria, but if the urgency is lacking or if the need can be planned, the provisions of § 8 para 1 no. 2 AMG do not apply, but the provisions of the AWEG apply to non-authorised medicinal products. An import certificate or a certificate of marketability is required, a movement declaration is required.

A Named Patient Use always refers to a previously known patient. This reference must be proven.

In contrast, a Compassionate Use Program within the meaning of § 8a AMG applies to a defined group of patients. If the BASG has approved a hardship case program by notice, the provisions of the AWEG are not applicable to the medicinal product in question. No import certificate, roadworthiness certificate or movement declaration is required.

 

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