Austrian law regarding medicinal products is heavily influenced by European Union legislation. The primary legal framework for pharmaceuticals (referred to as “medicinal products”) intended for human use is the Austrian Medicinal Products Act (Arzneimittelgesetz, or AMG). This act incorporates the key provisions of EU legislation, particularly Directive 2001/83/EC.

As of 28 January 2022, medicinal products intended for veterinary use are regulated by the Regulation on Veterinary Medicinal Products (Regulation (EU) 2019/6). Starting in January 2024, the new Austrian Veterinary Medicinal Products Act (Tierarzneimittelgesetz) will supplement this regulation in Austria.

Specific provisions in relation to medicinal products can also be found in other Austrian laws, such as the Austrian Pharmaceutical Products Import Act (Arzneiwareneinfuhrgesetz, or AWEG) or the Austrian Prescription Act (Rezeptpflichtgesetz). Furthermore, the manufacture and distribution of medicinal products is governed by several national ordinances (Durchführungsverordnungen), which are based on the AMG, including the Medicinal Products Operations Ordinance (Arzneimittelbetriebsordnung, or AMBO).

Medicinal products law is also increasingly regulated by directly applicable EU regulations – for example, Regulation (EC) 726/2004 (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceutical and Medical Devices), Regulation (EU) 536/2014 (“Clinical Trials Regulation”, or CTR), and Regulation (EC) 1394/2007 (“Advanced Therapy Medicinal Products Regulation”, or ATMPR).

As of 26 May 2021, medical devices have mainly been governed by the Regulation (EU) 2017/745 (“Medical Devices Regulation”, or MDR), which is complemented by the Austrian Medical Devices Act 2021 (Medizinproduktegesetz, or MPG) providing for rules regarding the safety, functionality and quality of medical devices with regard to their construction, operation, use and maintenance. Since 26 May 2022, in vitro diagnostic (IVD) devices have been governed by Regulation (EU) 2017/746 (“In Vitro Diagnostics Regulation”, or IVDR), which is likewise complemented by the MPG. The MPG came into force on 1 July 2021 for medical devices and on 26 May 2022 for IVD devices.

The competent national authority for medicinal products, medical devices and IVD devices is the Austrian Federal Office for Safety in Healthcare (Bundesamt für Sicherheit im Gesundheitswesen, or BASG). The BASG is responsible for the approval and control of medicinal products in Austria and the control and approval of clinical trials (see 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial). Together with the competent European agencies, the BASG further monitors at the national level the medicinal products, medical devices, and IVD devices already on the market in terms of their efficacy, safety, production, transport, and storage.

Decisions by regulatory bodies qualify as specific administrative acts (Bescheide), which can be challenged by the addressee – or by a (third) party having a legal interest, if applicable – by lodging an appeal with the regulatory body that issued the administrative act. The decision on the appeal is made by the competent administrative court.

Appeals against administrative acts must be made in writing and – unless the respective regulation provides otherwise – filed within four weeks of the date of the decision to be challenged. The appellant is not legally obligated to be represented by an attorney.

In Austrian medicinal products law, various criteria exist based on which medicinal products are categorised and regulated differently. By way of an example, the AMG distinguishes between medicinal products available for the patient only upon prescription and over-the-counter (OTC) medicinal products available without prescription. Medicinal products requiring prescription may not be advertised to the general public (“laymen”) but, rather, only to healthcare professionals under the preconditions laid down in the AMG.

The AMG makes another relevant distinction between medicinal products that are, in principle, subject to marketing authorisation – known as “medicinal specialities” (Arzneispezialitäten) – and medicinal products not subject to such authorisation. Furthermore, the AMG differentiates on the basis of the material composition of a medicinal product (eg, biological medicinal products, herbal medicinal products, radioactive medicinal products, or homoeopathic medicinal products).

Likewise, the Ministry of Health may qualify medical devices as requiring a prescription or as only available through certain specialised dealers. Prescription-only medical devices may not be advertised to the general public, either. However, in practice, the vast majority of medical devices are freely available and not qualified as prescription-only or are exclusively available in specialist stores.

There is an important distinction between in-vitro diagnostic (IVD) devices, which are governed by the In Vitro Diagnostic Regulation (IVDR), and other medical devices, which fall under the Medical Device Regulation (MDR). Additionally, the MDR and IVDR categorise devices based on their purpose or use, such as active devices, implantable devices, invasive devices, or single-use devices. They also classify devices according to their inherent risks:

• medical devices are classified into Classes I, IIa, IIb, and III; while
• IVD devices are categorised into Classes A, B, C, and D.

As of 1 February 2022, the regulatory system for clinical trials of medicinal products underwent a comprehensive restructuring aimed at further harmonising the rules on the conduct of clinical trials within the EU member states. The legal framework of clinical trials on medicinal products is now essentially defined by the CTR, thereby replacing the former system for clinical trials based on Directive 2001/20/EC. Supplementary provisions for national implementation and within the scope of so-called opening clauses of the CTR have been introduced into the Austrian legal system through the AMG.

If genetically modified organisms (GMOs) are used for therapeutic purposes – as defined in Section 4(24) of the Austrian Gene Technology Act (Gentechnikgesetz, or GTG) – in the course of a clinical trial, a prior permit according to Section 74 of the GTG must also be obtained.

Clinical trials of medical devices (known as “clinical investigations”) are mainly regulated by the MDR and clinical trials of IVD devices (known as “performance studies”) are regulated by the IVDR. Supplementary provisions have been included in the MPG.

For non-interventional studies, the CTR and the MDR/IVDR provisions do not apply. Instead, there are specific national provisions in the AMG and the MPG for these studies, including provisions concerning data protection and inspections by the BASG. The following may also apply:

• general provisions of civil, criminal and data protection law; or
• specific rules for clinical research under, for example, the Austrian Hospital and Sanatoria Act (Krankenanstalten- und Kuranstaltengesetz, or KAKuG) or the Austrian University Act 2002 (Universitätsgesetz, or UG).

Since 31 January 2023, all new applications for clinical trials of medicinal products must be submitted in accordance with the CTR. The authorisation procedure is initiated by the sponsor sending the application dossier to the EU member states concerned via the EU portal, known as the Clinical Trials Information System (CTIS). The reporting member state must then carry out a validation within ten days and notify the sponsor via the portal of the results. In Austria, the BASG is responsible for the validation procedure, whereby the ethics committee can issue an opinion on certain parts of the application (Section 31, paragraph 4 of the AMG). The validation procedure is followed by the evaluation procedure, which is divided into two parts.

• Part I is a co-ordinated assessment of the application between the reporting and concerned member states, in which aspects of the clinical trial – such as whether it is minimally interventional, the expected therapeutic and public health benefits, and the risk of harm posed to the trial subjects – are evaluated. The assessment report must be prepared and submitted within 45 days of validation; however, this term may be extended under certain conditions. The responsibilities regarding Part I of the assessment procedure are divided nationally between the BASG and an assessing ethics committee (Section 35 of the AMG).
• Part II of the evaluation procedure includes the aspects to be assessed nationally by each member state – for example, requirements for informed consent, patient recruitment, and subject insurance. The evaluation report must also be submitted within 45 days of validation. In Austria, the responsibility for preparing the assessment report in Part II is assigned to the evaluating ethics committee.

Each member state must then decide to authorise the clinical trial within five days of the conclusion of the evaluation procedure. If a timely notification is not made, the conclusion regarding Part I of the assessment report is automatically deemed to be the decision of the respective member state.

The approval process for a clinical investigation of a medical device generally adheres to the guidelines set forth in the MDR (as outlined in MDR’s Article 62, paragraph 1. Depending on the nature of the investigation, various procedures may apply, such as authorisation, notification, or instruction procedures.

An application for authorisation must be submitted electronically to the BASG. Upon receipt of the application, the BASG must carry out the validation within ten days.

With regard to Class I investigational devices or Class IIa/IIb non-invasive devices, the clinical investigation may be commenced immediately after validation ‒ provided that the BASG has confirmed proper notification and the ethics committee has given a favourable opinion (ie, notification procedure).

In the case of other investigational devices (Class III investigational devices or Class IIa/IIb invasive devices), the clinical investigation may only commence after notification of the authorisation by the BASG ‒ again with the prerequisite that a favourable opinion by the competent ethics committee must be provided. The decision about the authorisation must usually be communicated to the sponsor within 45 days of validation (ie, authorisation procedure).

Under certain conditions, a different procedure applies to clinical investigations of medical devices that already bear a CE marking, thereby confirming conformité européenne (“European conformity”) (Article 74 MDR). The sponsor must notify the BASG of the conduct of such an investigation at least 30 days before it begins. In this case, the BASG will confirm the notification without further subsequent assessment (ie, information procedure).

Clinical investigations of medical devices for purposes other than the demonstration of conformity are also subject to prior approval by the BASG if they impact the diagnostics and/or therapy of a trial subject (Article 82 of the MDR, in conjunction with Section 13, paragraph 3 of the MPG); otherwise, it is only necessary to conduct an information procedure.

For performance studies on IVD devices, the provisions of the MPG are largely applicable mutatis mutandis – although there are certain exceptions (see Article 66 et seq of the IVDR and Section 36 of the MPG for comparison).

For medicinal products, information on clinical trials initiated under the CTR as of 31 January 2022 (including the start and end dates of the trial, details of the sponsor, and trial results) is publicly available on the EU Clinical Trials website. Information on clinical trials initiated under the former system of Directive 2001/20/EC (before 31 January 2022) may still be accessed via the EU Clinical Trials Register.

No publicly accessible register is currently provided at the EU or national level for clinical investigations and performance studies under the MDR and the IVDR. However, information on such trials will be accessible via the EUDAMED database as soon as the entire EUDAMED system has been declared fully functional.

At the national level, the legislator did not exercise the option to provide for the maintenance of a (publicly accessible) register for non-interventional studies of medical devices via ordinance.

In Austria, it is not generally prohibited to conduct the consent procedure remotely or to remotely supervise certain tasks/procedures carried out at home by a physician. Remote access to source data for the purpose of monitoring is also permissible; however, this only applies to original electronic medical records and where a correspondingly validated record system is being used.

In December 2022, the EU Decentralised Clinical Trial (dct) project team published a recommendation paper on decentralised (remote) elements in clinical trials. The team comprises experts from the Clinical Trial Coordination Group, the Clinical Trial Expert Group, European Medicines Agency (EMA) scientific committees, EMA working parties, and EMA staff. This document also includes guidance concerning national provisions on the use of online tools in clinical studies within the EU.

As regards special measures due to COVID-19, see 11.2 Special Measures Relating to Clinical Trials.

Clinical studies involve the processing of patients’ contact and health information, which qualify as personal data as defined by Article 4(1) of the General Data Protection Regulation (EU) 2016/679 (GDPR). To the extent that patients are identified or at least identifiable in data resulting from the clinical trial, these data sets must also be qualified as special categories of personal data (sensitive data).

The processing of personal data in the context of a clinical trial is generally based on the patient’s consent pursuant to Article 6, paragraph 1(a) – in the case of sensitive data in conjunction with Article 9, paragraph 2(a) – of the GDPR. Accordingly, any disclosure of personal data to third parties must be covered by this consent.

Furthermore, personal data can also be processed in the course of scientific research on the basis of the Austrian Research Organization Act (Forschungsorganisationsgesetz, or FOG), provided that the processing methods mentioned there, such as anonymisation or pseudonymisation, are concerned (Article 2(2)(1) FOG).

The processing of personal data (including sensitive data) within databases is subject to compliance with the GDPR, (potentially) the FOG and the Austrian Data Protection Act (Datenschutzgesetz, or DSG).

The distinction between medicinal products and medical devices is made in accordance with the product definitions as outlined in the AMG (Section 1, paragraph 1) and the MDR (Article 2(1)).

“Medicinal products”, within the meaning of the AMG, are substances or preparations of substances that either:

• are intended for use in or on the body and as agents with properties to cure or alleviate or prevent diseases or pathological complaints (so-called presentation medicinal products); or
• may be applied in or on the body or administered to a human (so-called functional medicinal products) with a view to either:
1. restoring, correcting or modifying physiological functions by a pharmacological, immunological or metabolic action; or
2. making a medical diagnosis.

According to the MDR, the term “medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means:

• the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
• the diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
• the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; and
• for providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

Furthermore, devices for the control or support of conception and certain products specifically intended for the cleaning, disinfection or sterilisation of devices will be deemed medical devices.

The distinction between medicinal products and medical devices can be made, in most cases, on the basis of the principal mode of action of the product (see Article 1, paragraph 6(b) of the MDR). A product with an essentially pharmacological, immunological or metabolic action should not be classified as a medical device. The principal mode of action of medical devices is mostly of a physical or mechanical kind.

In the case of diagnostic devices, distinction must be made on the basis of the nature of the product (substance/instrument, apparatus, etc) and the place of application (in vivo or in vitro).

In Austria, manufacturers of products (or their representatives) may initiate a procedure with the BASG, whereby questions concerning the product classification ‒ including the demarcation between the medicinal product and the medical device status of the product ‒ will be clarified (Section 10 of the MPG and Section 49a of the AMG).

Within the meaning of the AMG, the term “biological medicinal products” comprises:

• certain immunological medicinal products;
• certain medicinal products manufactured by using human blood or blood plasma as a starting material; and
• medicinal products listed in Annex I (1) and (1a) Regulation (EC) 726/2004, such as:
1. medicinal products developed by means of recombinant DNA technology, controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes (including transformed mammalian cells), or hybridoma and monoclonal antibody methods; and
2. ATMP.

Austrian law does not provide for a marketing authorisation procedure specific to biological medicinal products. However, for medicinal products listed in Annex 1(1) and (1a) Regulation (EC) 726/2004, a central marketing authorisation according to said regulation is mandatory. In addition, differences with regard to the required application documents may arise for different types of biological medicinal products.

Furthermore, the AMG contains specific provisions for certain immunological medicinal products, as well as medicinal products manufactured by the use of human blood or blood plasma. According to Section 7, paragraph 8 of the AMG, for example, blood and blood components intended for direct transfusion are exempt from the obligation to obtain a marketing authorisation. Also, a batch release may be required as a prerequisite for supplying certain biological medicinal products in national Austrian law (see Section 26 of the AMG). Lastly, specific provisions for so-called biosimilars can be found in Section 10, paragraph 6 of the AMG.

The BASG generally grants a national marketing authorisation of a medicinal product for a period of five years (Section 20, paragraph 1 of the AMG). An extension of the marketing authorisation (at the request of the marketing authorisation holder) is valid without a time limit unless the BASG again sets a time limit of five years for reasons of pharmacovigilance.

If an authorised medicinal product has not actually been placed on the domestic market within three years of the marketing authorisation being granted or has not been on the market for three consecutive years, the marketing authorisation may expire in accordance with Section 22 of the AMG (the so-called sunset clause). In certain cases, the marketing authorisation must also be revoked. Similar rules apply according to Regulation (EC) 726/2004 with regard to the period of validity of marketing authorisations for medicinal products authorised under the centralised procedure.

The placing on the market of medical devices is not subject to a marketing authorisation; however, the manufacturer must perform a conformity assessment procedure (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices). According to Article 56 of the MDR, certificates of conformity issued by the notified bodies will be valid for the period they indicate, which must not exceed five years. Upon application by the manufacturer, the validity may be extended for further periods (of no more than five years), based on a re-assessment. The CE marking will be suspended, restricted or withdrawn if a notified body finds that the manufacturer no longer meets the requirements of the MDR.

Marketing Authorisation for Medicinal Products

There are, in practice, four different procedures for obtaining a marketing authorisation for medicinal products.

• Marketing authorisation must be obtained via the centralised procedure for medicinal products according to Annex I Regulation (EC) 726/2004 (eg, ATMP). Under certain conditions (see Article 3, paragraph 2), the centralised procedure is also available for other medicinal products. A marketing authorisation obtained under the centralised procedure is issued by the European Commission and is valid in all EU member states. Applications must be submitted to the EMA.
• For other medicinal products, marketing authorisation may be obtained under the national procedure according to Sections 7 et seq of the AMG via application to the BASG. The BASG is also the competent authority for issuing the national marketing authorisation, which is only valid on Austrian territory.
• Where a national authorisation already exists in a member state, it may be extended to the territory of other member states through a mutual recognition procedure (Section 18a of the AMG).
• For medicinal products that cannot be authorised under the centralised procedure, marketing authorisation in different EU member states may be applied for through a decentralised procedure (Section 18a of the AMG).

Variations to marketing authorisations

Variations to marketing authorisations are governed by Regulation (EC) 1234/2008 for all types of authorisations. Depending on the degree of health risk and the impact on quality, safety and efficacy, either a simple notification procedure, a notification obligation with a prohibition reservation or a prior authorisation procedure is required. In contrast, applications for authorisation extensions (eg, in the case of relevant changes to the active substance) must be evaluated according to the same procedure as the application for the original authorisation.

Transfers of marketing authorisations

Transfers of marketing authorisations obtained through the centralised procedure must be requested from the EMA in accordance with the guidelines established in Regulation (EC) 2141/96. If this process is not followed, then Section 25 of the AMG applies. According to this section, a waiver declaration of the authorisation from the previous marketing authorisation holder and an acceptance declaration from the new holder (transferee) must be submitted to the BASG.

Medical Device and IVD Device Compliance

Placing medical devices and IVD devices on the market is not subject to obtaining a marketing authorisation; however, medical devices or IVD devices may only be placed on the market or put into service if they comply with the MDR/IVDR. Specifically, they must meet the general safety and performance requirements, taking into account their intended purpose. Also, an assessment of the conformity of the device must be conducted, and a corresponding declaration of conformity must be issued. Depending on the risk classification of a medical device, a notified body must be involved in the process. The CE marking of the product indicates conformity with the applicable requirements. Transfers of CE markings are not provided for in the MDR/IVDR.

Medicinal Products

Medicinal products subject to marketing authorisation are a prerequisite for lawful market placement in Austria. For this reason, opportunities to supply such medicinal products to patients without marketing authorisation are limited. Nevertheless, there are a number of exceptions to this principle. The following are among the exceptions to the authorisation requirement.

• Named Patient Use (Section 8, paragraph 1(2) of the AMG) – no marketing authorisation is needed if a physician or dentist authorised to practise independently in Austria certifies that:
1. a medicinal product is urgently needed to prevent a threat to life or serious damage to the health of a specific patient; and
2. this threat or damage cannot be prevented with an authorised and available medicinal product according to the state of the art.
• Compassionate Use Programmes (Section 8a of the AMG and Article 83 of Regulation (EC) 726/2004) – marketing authorisation is not needed within Compassionate Use Programmes, which may be established (subject to prior approval by the BASG) for a defined group of patients suffering from a debilitating chronic or severe disease or whose disease is life-threatening and cannot be satisfactorily treated with an authorised and available medicinal product.
• Clinical trials (Section 8, paragraph 1(1) of the AMG) – medicinal products intended for the use in non-clinical or clinical studies or clinical trials do not need a marketing authorisation.
• Hospital exemption (Section 7, paragraph 4 of the AMG and Article 28 of Regulation (EC) 1394/2007) – ATMP that are manufactured on a non-routine basis in Austria on the basis of an individual medical prescription specifically for a particular patient, in order to be used on that patient in an Austrian hospital under the exclusive professional responsibility of a physician, are not subject to marketing authorisation.
• Officinal and magisterial medicinal preparations (Section 7, paragraphs 2 and 3 of the AMG) – certain medicinal products manufactured in pharmacies are not subject to marketing authorisation.

Further exemptions are listed in Sections 7 et seq of the AMG.

It should be noted that a marketing authorisation is a prerequisite for placing medicinal products on the market but not for their use. For this reason, medicinal products can, in principle, be used on patients beyond the scope of their marketing authorisation (off-label use). In this context, however, the physician has increased obligations to provide information to the patient.

Medical Devices and IVD Devices

With regard to medical devices and IVD devices, the MDR/IVDR provides exemptions from the obligation of CE marking for custom-made devices, investigational devices, and devices for performance studies (Article 20 of the MDR and Article 18 of the IVDR). Furthermore, the placing on the market and putting into service of a medical device for which no conformity assessment has been carried out may be authorised by the BASG in specific cases upon request for reasons of public health or patient health and safety (Article 59 of the MDR, Article 54 of the IVDR and Section 12 of the MPG).

As per the above-mentioned definition of Named Patient Use, if a physician or dentist authorised to practise independently in Austria confirms that a medical device is required for a specific patient in order to avert a danger to life or a serious impairment of health ‒ and that the treatment cannot be expected to be successful with a medical device for which conformity assessment procedures have already been carried out ‒ then such authorisation is not necessary. The same applies to medical devices used in connection with certain deployments of the Federal Armed Forces (Section 12, paragraphs 2 and 3 of the MPG).

Finally, under certain conditions, there are far-reaching exemptions from the MDR/IVDR obligations for in-house products manufactured and used only in healthcare facilities (Article 5, paragraph 5 of the MDR/IVDR and Section 9 of the MPG).

Medicinal Products

Holders of a marketing authorisation for a medicinal product must operate a pharmacovigilance system (Section 75i et seq of the AMG). Within the framework of this system, the holder must, among other things:

• appoint a pharmacovigilance officer;
• keep a pharmacovigilance master file;
• operate a risk management system;
• monitor the results of risk minimisation measures;
• monitor pharmacovigilance data; and
• subject the pharmacovigilance system to regular audits.

The applicable law also provides for reporting obligations (Section 75j of the AMG, Article 28 of Regulation (EC) 726/2004 and Article 107 of Directive 2001/83/EC) and information obligations of the holder (Section 75m of the AMG). In addition, holders are obliged to regularly prepare periodic safety update reports (PSUR) and transmit them electronically to an archive maintained by the EMA.

Other obligations of the holder include the following, as outlined below.

• The holder must inform the BASG about the date of actual placing on the market of a medicinal product, as well as a temporary or permanent removal from the market (Section 21 of the AMG).
• The holder must ensure that complete documentation of all activities related to the marketing authorisation or the medicinal product is available at all times (Section 24b of the AMG).
• If concerns arise regarding the medicinal product’s risks, the holder may face additional requirements or conditions imposed by the BASG, such as the performance of post-authorisation safety studies. If findings on the disease or clinical methodology indicate that previous assessments of efficacy may need to be significantly corrected, an efficacy study must be imposed (Section 19a of the AMG).

Medical Devices and IVD Devices

For medical devices and IVD devices, the MDR/IVDR require the manufacturer to plan, establish, document, implement, maintain and update a post-market surveillance system as part of the quality management system in a manner appropriate for the risk class and type of the product (Article 83 of the MDR and Article 78 of the IVDR). To this end, a post-market surveillance plan must be established (Article 84 of the MDR and Article 79 of the IVDR) and post-market surveillance reports must be prepared and updated (Article 85 of the MDR and Article 80 of the IVDR). Further obligations concern, for example, the preparation of PSUR (Article 86 of the MDR and Article 81 of the IVDR), the reporting and analysis of serious incidents and safety corrective measures (Articles 87 and 89 of the MDR and Articles 82 and 84 of the IVDR) and trend reports (Article 88 of the MDR and Article 83 of the IVDR).

On an EU level, the EMA publishes a monthly list of medicinal products under current evaluation under the centralised procedure. A list of all medicinal products that have received marketing authorisation under the centralised procedure is provided in the “Union Register” published by the European Commission. This register includes information on the name of a product, the registration number, name and address of the marketing authorisation holder, the active substance, the therapeutic indication, and relevant documents – as well as suspended, withdrawn or refused marketing authorisations.

On a national level, the BASG keeps a public register of all medicinal products for which a national marketing authorisation has been obtained (Arzneispezialitätenregister). Any granting, variation, cancellation and transfer of a marketing authorisation must be entered into this register. Entries regarding the granting of a marketing authorisation include information on the authorisation number, the name of the product, the authorisation holder, prescription-only or narcotic status, and the composition of the medicinal product.

Furthermore, the BASG operates an internet portal on medicinal products for public information purposes. In addition to information on the granting of marketing authorisation and the variation of a medicinal product, the BASG shall (inter alia) publish the technical information and approved directions for use, information on approved variations, and the conditions and constraints of marketing authorisations. Also, every expert opinion provided in the context of an application for marketing authorisation shall be published after all confidential information in the party’s commercial interest has been removed.

Information on products authorised via a mutual recognition procedure can be found in the MRI Product Index. Information on medical devices and IVD devices (including summaries of safety and clinical performance) and their manufacturers and importers, as well as certificates, may be publicly accessed via the EUDAMED database.

In case of an application for a centralised authorisation granted by EMA, applicants can ask for an “accelerated assessment”, which reduces the timeframe for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing-authorisation application (from up to 210 days to 150 days). In order to be eligible for such accelerated assessment, applicants need to argue that the product is of major interest to public health and therapeutic innovation. The Austrian (national) regulatory landscape does not provide for a fast-track registration route.        

Regarding medical devices, the MDR and IVDR currently do not provide for accelerated procedures.

Austria is a member of the European Union. An authorisation granted by the European Medicines Agency (EMA) through the so-called “centralised procedure” is valid throughout the EU, and the respective medicinal product may be marketed in all member states.

Further, where a national authorisation already exists in an EU member state, it may be extended to the territory of other member states through a mutual recognition procedure (Section 18a of the AMG). For medicinal products that cannot be authorised under the centralised procedure, marketing authorisation in different EU member states may be applied for through a decentralised procedure (Section 18a of the AMG). See also 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices. Medical devices that have successfully undergone a conformity assessment in accordance with the MDR or IVDR, as applicable, and carry a CE mark can be marketed throughout the European Union.

The manufacture of medicinal products (including packaging, labelling and final release of the finished product) may only be carried out based on a manufacturing authorisation (known as an “operating licence”) to be applied for in accordance with the AMG.

The BASG grants the authorisation upon application, in which the applicant must provide details of:

• the nature, scope and location of the intended manufacturing activity;
• the nature, size, equipment, dedication and location of the premises (as well as their furnishings and equipment);
• the nature of the technical equipment; and
• the appointed Qualified Person (QP) (sachkundige Person) who needs to be appropriately qualified, experienced and reliable.

Another prerequisite for the manufacturing licence is a trade permit for the manufacturing of medicinal products. This is issued, in accordance with the Trade Act (Gewerbeordnung, or GewO), by the Trade Authority ‒ ie, the competent district administrative authority (Bezirksverwaltungsbehörde) at the intended manufacturing site. Such a permit requires the nomination of a “managing director under trade law” (gewerberechtlicher Geschäftsführer) who is appropriately qualified (as further defined in the GewO).

The manufacturing licence will only be issued after a successful on-site inspection of the manufacturing premises by BASG, during which the authority checks compliance with the requirements of the AMBO and ensures that the quality of the medicinal products as required for the health and life of humans (or animals) is ensured on the basis of the provided facts. The statutory timeframe for issuing a manufacturing licence is 90 days from submitting a complete application. Any additional requests by the authority or missing information identified in the inspection will lead to a clock stop.

The manufacturing authorisation is granted for a specific site, for specific manufacturing activities and types of medicinal products as specified in the application, and – in principle – for an unlimited period. However, the authorisation remains subject to regular GMP inspections by the BASG, and can be withdrawn in the case of any detected and non-remedied deficiencies.

The manufacture of medical devices and IVD devices is not subject to a specific governmental authorisation. However, requirements as applicable to any manufacturing activity – for example, those under construction law and under trade law regarding operating plants – will apply.

A wholesale dealer licence (WDL) (also called an “operating licence”) is required to carry out wholesale distribution of medicinal products. Such a licence is required not only if the respective entity actually carries out physical handling and storage of medicinal products but also for selling and supplying medicinal products – even though the actual logistics are outsourced to a third party (likewise requiring a WDL itself).

The WDL is granted by the BASG upon application, in which the applicant must provide details of:

• the nature, scope and location of the intended distributing activity;
• the nature, size, equipment, dedication and location of the premises as well as their furnishings and equipment;
• the nature of the technical equipment; and
• the appointed responsible person (fachkundige Person) for wholesale distribution being appropriately qualified, experienced and reliable.

Furthermore, a trade permit is also required for the wholesale of medicinal products (see 4.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices). Such a permit requires the nomination of an appropriately qualified managing director under trade law.

The WDL may only be issued after the BASG successfully inspects the wholesale distribution site. The statutory timeframe for issuing a WDL is 90 days from the submission of a complete application. Any additional requests by the authority or missing information identified in the inspection will lead to a clock stop.

The WDL is granted for a specific site and for specific distribution activities as specified in the application and is in principle for an unlimited period. However, the authorisation remains subject to regular Good Distribution Practice inspections by the BASG and can be withdrawn in the case of any detected and unremedied deficiencies.

No licence comparable to the WDL is necessary for the distribution of medical devices. However, a trade licence and an appropriately qualified managing director under trade law are necessary.

Finally, according to Section 67 of the MPG, registration in the publicly accessible Medical Devices Register is mandatory for all persons or entities responsible for placing medical devices on the market for the first time in the European Economic Area (EEA) and domiciled in Austria.

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The importation and transfer of “pharmaceutical products” (Arzneiwaren) is regulated under the AWEG. In this context, it should be noted that the term “pharmaceutical products” is not identical to the term “medicinal product” as defined in the AMG or Directive 2001/83/EC – rather, it is based on the customs tariff regulations of Regulation (EEC) 2658/87. The AWEG, therefore, does not apply to all medicinal products. Also, medical devices are explicitly excluded from its scope (Section 1, paragraph 2 of the AWEG).

Provisions for parallel imports of medicinal products are regulated in the AMG (in particular, Section 10c). Products that have been authorised for parallel import are exempt from the notification obligation under the AWEG. Furthermore, obligations for importers and exporters are provided by the AMBO (see, for example, Section 4a). Specific provisions for the importation of investigational medicinal products are regulated in the CTR (Articles 61 and 63). The transfer of investigational medicinal products within the EEA (and Switzerland) is exempt from the notification obligation under the AWEG (Section 6, paragraph 2 of the AWEG).

The BASG is competent in issuing import certificates, receiving notifications under the AWEG, and supervising compliance with the AMG, the AWEG, and the CTR. In addition, certain powers are granted to the customs administration under the AWEG.

General and specific obligations regarding the importation of medical devices and IVD devices are laid down in the MDR/IVDR (see, in particular, Articles 13 and 60 of the MDR and Articles 13 and 55 of the IVDR) and enforced by the BASG as the competent authority.

According to Section 4 of the AWEG, the following entities are entitled to apply for an import permit or carry out an importation notification for pharmaceutical products:

• public pharmacies;
• hospital pharmacies; and
• companies authorised to distribute pharmaceutical products in a state within the EEA.

The entitlement to apply for a parallel import authorisation is granted to the following entities, according to Section 9 of the AMG:

• professionals authorised to manufacture or wholesale the medicinal product concerned;
• operators of domestic public pharmacies; and
• pharmaceutical companies established within the EEA that are authorised to place the medicinal product concerned on the market.

Depending on their activities (eg, repackaging), importers may be subject to the operating licence requirement of Section 63 of the AMG (see also 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices and 6.1 Wholesale of Pharmaceutical and Medical Devices).

The MDR and the IVDR do not provide for specific legal requirements to act as the importer of record of medical devices or IVD devices. However, they define the importer as “any natural or legal person established within the Union that places a device from a third country on the Union market”. Importers must register in accordance with Article 28 of the MDR/IVDR.

Under the AWEG, pharmaceutical products imported from a state outside the EEA are subject to a prior importation permit issued by the BASG. Similarly, pharmaceutical products imported from a state within the EEA must be notified to the BASG in advance.

Section 11 of the AWEG, however, provides for extensive exceptions to these requirements, including exceptions for:

• medicinal products for which a marketing authorisation or an authorisation for parallel import has been obtained;
• medicinal products for Named Patient Use;
• medicinal products for use in a Compassionate Use Programme;
• medicinal products needed in the event of emergencies; or
• medicinal products for personal use, in an amount corresponding to the usual personal needs of the traveller concerned.

Parallel importation of medicinal products is subject to a prior authorisation by/notification to the BASG in accordance with Section 10c of the AMG (see also Article 57, paragraph 1(o) of Regulation (EC) 726/2004 for medicinal products authorised under the centralised procedure).

The importation of medical devices and IVD devices does not require any specific authorisation under the MDR/IVDR or the MPG.

The products subject to restrictions under the AWEG are determined based on the classification of goods according to the tariff and statistical nomenclature of the EU, as established by Regulation (EEC) 2658/87. Only those products that fall under the specific subheadings of the combined nomenclature listed in Section 2(1) of the AWEG – such as subheadings 3002 20, 3002 30, and 3004 – are considered “pharmaceutical products” within the context of the AWEG.

Austria is a member of the WTO. Furthermore, as a member state of the EU, Austria participates in free trade agreements concluded by the EU member states. It is worth noting that the current EU sanctions against Russia do not provide for trade blocs of medicinal products and medical devices.

The price basis of a medicinal product is the manufacturer’s factory or depot selling price (Fabriksabgabepreis/Depotabgabepreis, or FAP/DAP). Furthermore, the respective “mark-ups” (wholesale and pharmacy mark-ups, regulated by law) and VAT are added to this price. The FAP/DAP can be freely determined by the company authorised to distribute, and the Ministry of Health needs to be informed of this price.

For those medicinal products that are included in the list of reimbursable medicinal products, the so-called Reimbursement Code (Erstattungskodex, or EKO), the “EU average price” is relevant. This average price constitutes the maximum possible FAP/DAP for reimbursable products. For the purpose of calculating the EU average price, the Price Commission of the Ministry of Health considers the medicinal products with the same active ingredient, active ingredient strength, dosage form and identical (or approximately identical) package size.

The Price Commission determines the EU average price six months after the application for inclusion in the EKO is submitted. This is repeated 18 months after the first price determination and 24 months after the second price determination. The Price Commission can initiate a new price determination 18 months after the third price determination.

In the case of medicinal products that are not included in the EKO but exceed an annual turnover of EUR 750,000 at the expense of public health insurance (based on the FAP in the previous 12 months), the Umbrella Organisation of the Austrian Social Insurance (Dachverband, or DVB) must immediately notify the Price Commission, which then has eight weeks to determine an EU average price for the medicinal product. If the determined EU average price is lower than the applied price, the company authorised to distribute must reimburse the difference to the social insurance institutions within six months of exceeding the sales threshold.

The DVB applies the principles of price determination in accordance with the rules of procedure for the issuance of the EKO, as well as the economic evaluation criteria of the Therapeutic Products Evaluation Commission, and negotiates the reimbursement price with the manufacturer on this basis. Once an agreement has been reached, the reimbursement price specified in the EKO is binding, albeit subject to adaptation in accordance with the EU average price. If, on the other hand, a medicinal product is removed from the EKO by the decision of the DVB, the companies authorised to distribute the drug have the option to appeal to the administrative court.

Furthermore, specific price regulations apply if a successor product with the same active ingredient (generic or biosimilar) is available in the EKO.

With regard to generics, the price of the first generic successor product must be at least 50% below the price of the original branded product whose patent protection has expired. The price of the second generic successor product must be 18% lower than the price of the first successor product, and the price for the third successor product must be 15% lower than that of the second successor product. The original product’s price must be reduced by at least 30% within three months of the inclusion of the first generic product in the EKO. If there is a third successor product, all other providers must reduce the price to the price of the third product. Additional successors must offer price reductions of at least EUR0,10 in order to be included in the EKO.

With regard to biosimilars, the price of the first successor product must be at least 38% lower than the original product. The price of the second successor product must be at least 15% lower than that of the first successor product, and the price of the third successor product must be at least 10% lower than that of the second successor product. After that, the same regulation applies as for generics (ie, the original product must reduce its price by 30% within three months, etc).

In principle, no legal price control mechanisms are available for medical devices and IVD devices.

The price of a medicinal product can, in principle, be freely determined by the company authorised to distribute it but is limited by the EU average price of said product (as further detailed in 8.1 Price Control for Pharmaceuticals and Medical Devices).

In principle, no legal price-control/price-setting mechanisms are available for medical devices and IVD devices.

The Austrian General Social Security Act (Allgemeines Sozialversicherungsgesetz, or ASVG) states that, in case of illness, the insured person is entitled to health treatment comprising the provision of remedies (Heilmittel) ‒ a term that includes medicinal products, in particular. According to the ASVG, medical treatment must be adequate and appropriate, but it should not exceed what is necessary.

Austria is one of the few EU countries where the costs of reimbursable medicinal products prescribed by a physician are, in principle, covered in full for the patients insured in the public insurance system. Patients only have to pay a flat fee (“prescription fee”) in pharmacies. Exemption from the prescription fee is possible under certain conditions.

Medicinal products included in the EKO can be prescribed at the expense of health insurance institutions (see 8.1 Price Control for Pharmaceuticals and Medical Devices). Other medicinal products are only reimbursed in medically justified individual cases.

Regarding medical devices and IVD devices, no system comparable to the EKO exists. The Austrian Social Security Act does not refer to “medical devices” as such but to Heilbehelfe and Hilfsmittel (therapeutic aids), which are reimbursed ‒ subject to a 10% deductible (or a current minimum of EUR 40,40) ‒ if a physician prescribes them. Typically, medical device/IVD device manufacturers sign contracts with the social insurance institutions in order to avoid the social insurance institutions requesting a cost estimate in advance regarding devices if no contract between the social insurance institutions and the manufacturer is in place.

Any entity authorised to distribute a medicinal product approved and available in Austria may apply for inclusion in the EKO. The medicinal products undergo a pharmacological, medical-therapeutic, and health-economic evaluation regarding their eligibility for reimbursement. In this process, the DVB is supported by the Medicines Evaluation Commission (Heilmittel-Evaluierungs-Kommission, or HEK), an independent advisory body that is not bound by instructions. The HEK’s recommendations form the basis of the DVB’s decisions.

The EKO is divided into three areas (known as “boxes”), which are outlined below.

• The Green Box contains medicines that the health insurance institutions reimburse to the socially insured without special authorisation. These are freely prescribable.
• The Yellow Box includes drugs that social insurance institutions consider to have a significant additional therapeutic benefit for patients but which were not included in the Green Box for medical or economic reasons. For these medicines, health insurers reimburse the insured if the prescription has been approved by their chief medical office (dark yellow area RE1). In some cases, a retrospective control is also accepted (light yellow area RE2).
• The Red Box contains medicinal products for a limited time while the company’s request for inclusion in the EKO is being reviewed. During this period, the costs are covered only if there is approval from the chief medical office of the social insurance institutions.

Finally, even the so-called “no-box” medicinal products – ie, products for which no application has been made to be included in the EKO – can be reimbursed if the individual prescription has been approved by the chief medical office. As this option is usually chosen for very expensive medicines, the Austrian legislator has introduced a requirement that the EU average price be relevant to these products if turnover exceeds EUR 750,000 (see 8.1 Price Control for Pharmaceuticals and Medical Devices).

Changes within the boxes and deletions from the EKO are possible at the request of both the company authorised to distribute the product and the DVB (supported by the HEK’s recommendations).

If the social insurance institution refuses reimbursement in an individual case, the patient can file an action before the civil courts. In these proceedings, typically, the court reviews the social insurance institution’s decision with the help of a specific expert, who is entitled to decide on the reimbursement. The court’s decision may be challenged before the Higher Regional Court and, eventually, before the Supreme Court.

No system comparable to the EKO exists for medical devices and IVD devices. For reimbursement of medical devices and IVD, see 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds.

Essentially, pharmacies may only retail medicinal products, and physicians may only provide patients with medicinal products that require a prescription.

So far, the aut idem rule has not been implemented into Austrian law. Pharmacists are required to dispense to the patient the actual medicinal product prescribed (even if, for example, a generic product is available). The pharmacist can only offer the patient a pharmaceutical equivalent if the prescribed product is unavailable.

Medical devices and IVD devices are not pharmacy-only products.