Commercialisation of healthcare in Austria: overview

A Q&A guide to the commercialisation of healthcare in Austria.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Austria. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Karina Hellbert, Fiebinger Polak Leon & Partner Rechtsanwälte
Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

Medical products are regulated by the Medicines Act, which contains rules on:

  • Manufacturing and distribution.

  • Marketing authorisation.

  • Clinical trials.

  • Advertising.

  • Gifts to healthcare professionals.

The manufacturing of products is further detailed by an Ordinance governing the Activities of Companies Producing, Controlling, or Placing Medicinal Products on the Market. The import of medicinal products is also separately regulated by the Act on Importation of Medicinal Products 2010.

For medical devices, the main body of rules can be found in the Medical Devices Act and in the Act on the Manufacturing of Medical Devices. All types of medical devices are governed by the Medical Devices Act. Under the Trade Act, medicinal products and medical devices can normally only be manufactured and distributed by individuals who have passed a certain examination and can prove practical experience concerning these product categories. However, for certain medical devices, the Ministry of Health issued a specific ordinance also allowing general retailers and specialised shops providing primarily health-related products to sell certain low-risk medical devices.

Regulatory authorities

Generally, the Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) is the regulatory authority responsible for medicinal products, in particular for granting marketing authorisations and supervising compliance with medicine rules. The BASG itself is supervised by the Federal Ministry for Health. In particular, it is assisted with marketing authorisations, scientific evaluations and inspections by the Medicines Agency (Medizinmarktaufsicht), which is organised as a limited liability company. Therefore, the Medicines Agency has the expertise and the resources for handling marketing authorisations, inspections and surveillance measures and prepares the decisions for the BASG. The decisions adopted are publically available. The Medicines Agency also handles the granting of marketing authorisations for Liechtenstein.

The BASG and the Medicines Agency also handles medical devices.

For more information on the BASG and Medicines Agency see box: The regulatory authorities.

Private parties

Private parties do not play any role in the evaluation of marketing applications for medicinal products. They simply file an application and therefore become a party to the administrative proceedings. Competitors play an indirect role since, if there are violations of advertising rules applicable to medicinal products or medical devices, then competitors can initiate civil proceedings based on the Act against Unfair Competition (Gesetz gegen den unlauteren Wettbewerb). With a medical device, private bodies accredited by the Ministry for Economics are involved in establishing conformity with the essential requirements imposed by the EU legislation applicable to medical devices. If conformity is established, a CE marking can be affixed to the product.

 
2. What types of medical products are regulated?

The Medicines Act covers various types of medicinal products, including:

  • Medicinal products per se.

  • Generics.

  • Biosimilars.

  • Homeopathic products.

  • Traditional herbal products.

  • Products used for somatic gene therapy.

  • "Traditional" drug substances.

For medicinal products containing genetically modified organisms, the Gene Technology Act also applies. Food products serving special dietary needs must be notified to the Ministry of Health before being placed on the market for the first time. For this notification, the label must be enclosed. For other food products, such as food supplements, no licence is needed for placing those products on the market. These products are generally governed by the Act concerning the Safety of Food Products and Protection of Consumers. In essence, these products are not allowed to be of such quality that would endanger human health and must not contain any disease-related claims. The Medical Devices Act covers:

  • Medical devices.

  • In vitro diagnostics.

  • Active medical devices.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

The manufacturing of medicinal products is governed by the Trade Act and the Medicines Act. It is a "restricted trade" that requires a specific licence under the Trade Act.

The manufacturing, distributing or controlling of medicinal products requires an authorisation from the Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) (section 63, Medicines Act). An application for such a manufacturing licence must include:

  • A description of the tasks envisaged.

  • The production volume.

  • The place of manufacturing.

  • The condition of the manufacturing facility.

  • The size of the facility.

  • The zoning classification.

  • The equipment used.

  • A description of the technical equipment.

  • The name of the qualified person, if applicable.

Before such a licence is granted, the BASG performs at least one inspection of the manufacturing premises.

If the facility does not compromise human or animal health, the authorisation is granted after an initial inspection. Further inspections will occur regularly (at least every three years).

To obtain the necessary approval under the Trade Act, at least one person must have passed an examination, proving that he has the necessary legal and scientific knowledge and skills for manufacturing or distributing medicinal products. In addition to the licence under the Medicines Act, an operation licence under the Trade Act is also required.

Advertising

Advertising medicinal products is regulated in the Medicines Act and via codes of conduct, for example, the industry association Pharmig's Code of Conduct. Generally, advertising must not be misleading, either to consumers or to healthcare professionals. This means that, for example:

  • Properties of the medicinal product must not be exaggerated.

  • Information or pictorial presentation must not indicate that the product's effect exceeds the actual effect.

  • Success cannot be claimed as achievable in any event.

Violations of those rules can be enforced by public authorities or competitors under the Unfair Trade Practices Act, or arbitrated under the Pharmig Code of Conduct. Off-label advertisement is prohibited, except during international congresses.

Sale

For medicinal products to be sold, the BASG must issue a marketing authorisation, which is granted to applicants established within the European Economic Area (EEA) and fulfilling the requirements imposed by the Medicines Act. Once granted, the authorisation is initially valid for five years and then subsequently indefinitely unless revoked or suspended. For certain products, a second five-year period can be imposed. An authorisation can be revoked if the BASG finds evidence of non-compliance with certain requirements during one of their regular inspections of manufacturing facilities, or if the risks associated with the product outweigh the benefits.

Medicinal products can only be sold by pharmacists (a pharmacy monopoly). Recently, sale via the internet through approved internet pharmacies has also been allowed. This is regulated by the Medicines Act and the Pharmacy Act, which clearly establish the distribution chain for sales of medicinal products. The fees that can be charged by wholesalers are also regulated.

Regarding the price of medicinal products, marketing authorisation holders can freely determine the price of over-the-counter (OTC) products. However, the price of prescription products is fixed and reimbursed under the national health insurance system. This price cannot exceed the EU average price. People who work in Austria (and certain non-working family members such as spouses and children) are members of mandatory regional health insurance funds, which reimburse pharmacists for prescribed medication. To be reimbursed, products must be included in the Reimbursement Codex, which consists of four types of box:

  • The red box is where every reimbursement application begins.

  • Within 180 days, those products are then placed in the:

    • dark yellow box (this is for products with a significant therapeutic value and the use of which must be approved by a physician employed by one of the sick funds;

    • light yellow box (this is for products that do not need to be approved by a physician employed by one of the sick funds but must be documented according to binding guidelines); or

    • green box (this is for all other products whose prescription by physicians must be medically and economically justified).

 
4. Are there different requirements for patented and generic drugs?

The Medicines Act provides that a patent is not an obstacle for the review of a generic product's marketing authorisation. In addition, if a product is not marketed due to an existing patent, the marketing authorisation of the generic product will not automatically be withdrawn after three years of non-marketing (as stipulated in the sunset clause).

Marketing authorisations for generic products are granted through a simplified procedure. There is no need for applicants to provide documents concerning pre-clinical and clinical trials if:

  • The active substance has been in well-established use for ten years within the EU.

  • The marketing authorisation holder has consented to using the data.

  • The product has been on the EU market for eight years.

Biosimilar medicinal products are regulated slightly differently because, due to their characteristics, they are not classified as generics. Applications for biosimilar medicinal products must show that, due to the degree of natural variability, the biosimilar does not affect safety or effectiveness in comparison to the innovator.

The provisions of Austrian law comply with EU legislation, but fees in the approval process are substantially reduced for generic products.

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) is the regulatory authority responsible for regulating drugs, in particular for granting marketing authorisations. The technical aspects of the dossier are examined by the Medicines Agency, which also prepares the decision on whether a medicinal product should be approved or not.

For more information on the BASG see box: The regulatory authorities.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

Under Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive), there is a mutual recognition procedure (MRP) and a decentralised procedure (DCP). For an applicant that chooses one of these routes, the Medicines Agency has posted on its webpage the relevant forms to be completed, depending on whether Austria acts as a reference member state or as a concerned member state. In relation to quality or efficacy, the requirements cannot be lowered. However, in countries where the Medicines Agency only acts as a concerned member state, the fees for obtaining a marketing authorisation are substantially lower. Concerned member states have limited possibilities to object to a marketing authorisation if the reference member state is of the opinion that the marketing authorisation must be granted or has already been granted. In cases of objections, an arbitration procedure applies at EU level.

In addition to the Medicines Act, the Act Governing the Importation of Medicinal Products regulates the commercial and private importation of medicinal products, in particular over the internet.

The importation of medicinal products not covered by a European Economic Area (EEA) marketing authorisation must be approved in Austria. Imported products with an EEA marketing authorisation which do not have a national authorisation and are either re-exported or used for scientific or medical purposes must be notified to the Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG). If the products are used as investigational products, no notification is required. Recently, this has also applied to products manufactured in Switzerland.

The following can be imported freely without the necessity of approval by or notification to the BASG:

  • Centrally-approved products.

  • Products with an Austrian marketing authorisation.

  • Products that do not require a marketing authorisation at all.

However, blood products must always be notified to the BASG, even if they have been approved within the EEA.

If products are imported in violation of these rules, they will be sent back or destroyed at the cost of the purchaser, and fines of up to EUR3,600 can be imposed (this amount is doubled in the case of repetition). The BASG can carry out inspections, open containers and take samples at premises (including customs warehouses) suspected of storing these products. Parallel-imported products can only be distributed if the BASG has granted a parallel import licence. To apply for this licence, information is required on, among other things:

  • The name and marketing authorisation number of the product authorised in Austria.

  • The state where the parallel-imported product is authorised.

  • The name and marketing authorisation number of the product to be parallel-imported.

  • The name and address of the marketing authorisation holder.

  • The name and address of the person responsible for re-labelling and re-packaging.

  • A declaration that, for example, the summary of product characteristics (SPC) and packaging and labelling do not deviate from the product authorised in Austria.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

For private purposes (that is, up to three packages), a private person can buy non-prescription medicinal products from a pharmacy established within the European Economic Area (EEA) over the internet.

However, prescription-only products can only be purchased in a national public pharmacy. Such pharmacies must comply with strict documentation requirements controlled by the Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG).

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

Over-the-counter (OTC) products that are not reimbursed by the social security funds can be advertised to consumers. Even reimbursed OTC products can be advertised if they were included against the will of the marketing authorisation holder in the Reimbursement Codex. Such advertising must objectively describe the properties of the medicinal product without any exaggeration:

  • It cannot include information or illustration indicating an effect exceeding its actual effect.

  • It cannot indicate that success can be expected in any way by taking such medicinal product.

  • Any and all information must be in line with the summary of product characteristics (SPC).

Non-approved medicinal products can be advertised at scientific events that primarily target non-Austrian professionals.

The Pharmig Code of Conduct also specifically regulates advertising via the internet. For example, websites can include non-promotional information on medicinal products, such as information on side effects or interaction with other substances. However, such information must be accompanied by an instruction to contact a physician or pharmacist. A company can also link complete evaluation reports, for example, those published by the Committee for Medicinal Products for Human Use (CHMP) established by the European Medicines Agency (EMA), or on websites of national authorities or medical research institutions. The Code also requires that, in the case of advertising to healthcare professionals, an access system is implemented so that only healthcare professionals can actually gain access to such information.

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

Manufacturing

The manufacturing and distribution of medical devices is regulated by the Medical Devices Act and by implementing regulations such as the Regulation for the Establishment, Manufacturing, Use and Maintaining of Medical Devices in Institutions Active in the Health Field. There is also an ordinance issued by the Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) which imposes on retailers and physicians the requirement to pay a contribution in the form of lump sums to the BASG in exchange for performing its vigilance tasks. The provisions of the Trade Act must also be complied with.

To manufacture medical devices, the Medical Devices Act does not require a specific authorisation for operating a production facility. However, a licence is required under Trade Act. The manufacturer must also comply with the Medical Devices Manufacturing Regulation 2007. Medical device manufacturers, when placing a medical device on the market for the first time, must notify Gesundheit Österreich Gmbh.

Advertising

The advertising of medical devices is regulated by the Medical Devices Act. Any advertising for medical devices must not:

  • Attribute characteristics that the product does not have.

  • Convey the message that success can be expected in any case.

  • Convey the message that (if used in compliance with the manual for use) the products cannot be harmful.

  • Contain misleading representations on complying with the essential requirements as imposed by the relevant legislation.

It is also forbidden to advertise products that by their presentation could be considered as medical devices, but which do not have the characteristics of a medical device.

Sale

The retail sale of medical devices requires a trade licence (with a few exceptions).

Medical devices bearing a CE mark, even if affixed in another EU member state, can be freely sold in Austria. They do not need any further approval by any Austrian authority.

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) and Medicines Agency (Medizinmarktaufsicht) are responsible for regulating the manufacture, advertising and sale of medical devices.

For more information on the BASG see box: The regulatory authorities.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

Medical devices can be freely imported from any other EU/European Economic Area (EEA) member states provided that they bear a CE mark.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

Medical devices bearing the CE mark can be freely imported by individuals from other EU/European Economic Area (EEA) member states.

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

Advertisement to consumers is prohibited for medical devices that:

  • Bear no CE mark.

  • Are only available on prescription.

  • Are intended to be solely used by professionals.

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

Biological products are medicinal products and must also be licensed.

Manufacturing

See Question 3, Manufacturing.

Advertising

See Question 3, Advertising.

Sale

See Question 3, Sale.

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

The Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) and Medicines Agency (Medizinmarktaufsicht) are responsible for regulating the manufacture, advertising and sale of medical devices.

For more information on BASG see box: The regulatory authorities.

 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

Biological products are considered medicinal products. Therefore, to be sold in Austria, biological products that have already been licensed/approved in another jurisdiction must therefore be authorised under the mutual recognition procedure (MRP) or the decentralised procedure (DCP).

 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

All biological products sold in Austria are prescription-only products, so they can only be obtained via a pharmacy. In general, buying prescription-only products over the internet is prohibited. The Medicines Importation Act allows the importation of three packages for personal use; in the case of prescription-only-products this must be through a public pharmacy.

 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

All biological products sold in Austria are prescription-only products and cannot be advertised to consumers.

 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

Natural health products include different types of product:

  • Traditional medicinal products and homeopathic medicinal products are covered by the rules of the Medicines Act.

  • Food supplements, vitamins, dietary products, minerals or similar products are normally considered as food governed by the food provisions, in particular by the Federal Safety Act concerning Food, Commodities and Cosmetic Products for the Protection of Consumers.

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Manufacturing

Traditional medicinal products and homeopathic products. The manufacturing, advertising and sale of traditional medicinal products and homeopathic products are regulated by the Medicines Act and the Trade Act.

Traditional medicinal products or homeopathic medicinal products must simply be registered. The following restrictions apply to homeopathic products:

  • They can only be administered orally or externally.

  • They cannot bear any specific therapeutic indication.

  • They must have a sufficient degree of dilution to guarantee the safety of the homeopathic product.

The following restrictions apply to traditional herbal medicinal products:

  • They can only display an indication exclusively appropriate to the traditional use of such products.

  • They must be exclusively used for administration in accordance with a specific strength and posology.

  • They can only be used orally, externally or via inhalation.

The registration procedure for traditional herbal medicinal products does not act as a substitute for a normal marketing authorisation procedure. Therefore, the period of traditional use (that is, the product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the EU) must have elapsed. The requirements regarding quality of these products are the same as for conventional medicinal products.

Food products. The production facilities for food supplements must be approved in accordance with the Trade Act. To obtain such approval, the application must contain among other things:

  • Details of the applicant.

  • Location of the facility.

  • A brief description of the activities that are planned to be undertaken at the facility.

  • An extensive project description of the business undertaking.

  • An assessment of the influence on the neighbourhood of the emission of noise, smell and water pollution.

  • Technical details concerning the equipment used in the facility and waste disposal.

Approval is granted by the competent regional trade authority.

Advertising

Whether advertising restrictions apply depends, for example for homeopathic products, on whether the homeopathic product requires a full licence or a simplified registration. If it is fully licensed, the same rules apply as for medicinal products (see Question 3, Advertising). If it only requires registration, claims for the homeopathic product must not contain any reference to a disease. Therefore, no therapeutic claims can be made. The claim used for homeopathic products cannot suggest nor imply efficacy, which is normally permissible for medicinal products. Food supplements can be advertised provided that the advertisement is not misleading and does not make any disease-related claims. Health-related claims are permissible if such claims have been approved by the European Food Safety Authority.

Sale

Traditional medicinal products and homeopathic products. These products can only be sold if they are registered in Austria. Such products can only be sold in pharmacies (pharmacy monopoly).

Food products. To place food products and supplements on the market, the following requirements must be met:

  • They must be safe.

  • They cannot endanger human health or be of minor quality.

  • They must be labelled in accordance with the relevant provisions.

For food supplements, the Ministry for Health has issued its own ordinance concerning labelling requirements. There is no need to obtain prior approval for placing these products on the market. These products do not need to be either notified to or registered with any Austrian authority. Food supplements can be freely sold in Austria if they comply with the requirements imposed at EU level.

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

Natural health products do not qualify as medicinal products provided that, taking into account the scientific state of the art, they do not trigger any adverse events. Therefore, they are considered as normal food products for which the Austrian Agency Food Safety (Österreichische Agentur für Ernährungssicherheit) (AGES) and the Ministry of Health are responsible.

Homeopathic and traditional medicinal products

The Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) and Medicines Agency (Medizinmarktaufsicht) are responsible for regulating the manufacture, advertising and sale of Homeopathic and traditional medicinal products.

For more information on the BASG see box: The regulatory authorities.

Food products

Food regulations are normally enforced by the nine Austrian regions. Several institution are involved in risk management and general policies. For example, the Austrian Agency Food Safety (Österreichische Agentur für Ernährungssicherheit) (AGES) is responsible for:

  • Evaluating the risk of food.

  • Providing risk communication.

  • Carrying out risk management for the public sector.

The Austrian regions are responsible for enforcing food regulations. The Ministry of Health oversees all activities in this field.

For more information on the Ministry of Health see box: The regulatory authorities.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

Homeopathic and traditional medicinal products

A product must always be registered in Austria. For homeopathic products, the mutual recognition procedure (MRP) and decentralised procedure (DCP) are also available. This means that the fees for obtaining a registration under Austrian law are lower and the Federal Office for Safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG) can only object to the registration for limited reasons.

For traditional herbal medicinal products, certain restrictions apply to the use of the MRP or DCP procedures.

Food products

Food products that are sold in other EU member states can also be sold in Austria, provided that the labelling is in German. However, certain food products may be considered by Austrian authorities to be, for example, medicinal products as Austria is still applies medicine rules to many food supplement products (for example, those containing a high level vitamins).

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

Homeopathic and traditional medicinal products

The same restrictions apply as for medicinal products. Therefore, these products can be sold over the internet if they are considered as over-the-counter (OTC) products, and by a registered "internet" pharmacy. No such restrictions apply to food products (see below, Food Products).

Food products

Any and all advertising of food supplements must not be misleading nor drafted in such a way that indicates that they will cure a disease or that the use of such products constitutes a surrogate for a healthy life. The electronic sale of food supplement products is possible, but has no good standing because of counterfeits, products of poor quality being sold and so on.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

Homeopathic and traditional medicinal products

For traditional medicinal products and homeopathic products, certain restrictions apply under the Medicines Act. In particular, homeopathic products cannot have any specific therapeutic indication.

Food products

Any and all advertising of food supplements must not be misleading nor drafted in such a way that indicates that they will cure a disease or that the use of such products constitutes a surrogate for a healthy life.

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

The rules applying to medical products are constantly changing. The framework for these rules is adopted at EU level and the authors are not aware of major changes to the Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive), which is the core legislation for the marketing of medicinal products.

 

The regulatory authorities

Ministry of Health (Bundesministerium für Gesundheit)

W www.bmg.gv.at

Principal responsibilities. The Ministry of Health oversees all activities relating to food safety, medicinal products and medical devices.

Federal Office for safety in the Health Field (Bundesamt für Sicherheit im Gesundheitswesen) (BASG)

W www.basg.gv.at

Principal responsibilities. The BASG is responsible for regulating the licensing, manufacturing of medicinal products and for enforcing rules relating to medicinal products. It is also in charge of enforcing rules and carrying out inspections relating medical devices.

Austrian Agency for Food Safety (Österreichische Agentur für Ernährungssicherheit) (AGES)

W www.ages.at

Principal responsibilities. The AGES's main task is to provide risk management relating to food products and investigate food. In particular, AGES operates various laboratories to examine food.



Online resources

Austrian Laws

W www.ris.bka.gv.at

Description. This is a cost-free website allowing all Austrian laws to be downloaded as well as the laws of the nine regions. Certain laws are also provided in English.



Contributor profile

Dr Karina Hellbert, Head of the Life Sciences and Pharmaceutical Law Department

Fiebinger Polak Leon Rechtsanwälte

T + 43 1 582 58
F + 43 1 582 58 2
E k.hellbert@fplp.at
W www.fplp.at

Professional qualifications. Austria, Lawyer, 2007

Areas of practice. Pharmaceutical law; medical devices; intellectual property law; patent litigation; data protection; unfair competition law; licensing; custom matters; IT; product liability; food law.

Languages. German, English, French

Professional associations/memberships. International Association of Young Lawyers (AIJA); International Association for the Protection of Intellectual Property (AIPPI); Österreichische Medizinische Gesellschaft.

Publications. Handbuch Pharmarecht, LexisNexis ARD ORAC, 2013.


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