1. What are the criteria for a drug to be authorized as a pharmaceutical product in Austria?

In general, a pharmaceutical product is always produced

• in advance (before distribution to doctors, pharmacies, etc.)
• using the same ingredients in the same proportion
• under the same name
• using the same ingredients in the same proportion
• to be distributed only in a form designated for the end user (final packaging)

A drug is authorized as a pharmaceutical product after the authorization procedure (see below) is complete. It receives an authorization number and is entered into the “pharmaceutical products register”. All authorized phar-maceutical products are listed in the so-called “Austria-Codex”.

A pharmaceutical product contains the following:

• The actual preparation, containing

a) the active ingredient (synthetic or natural)

b) the excipient (fillers, coatings, flavors, etc.)

• The packaging, i.e.

a) primary packaging (around the actual product, e.g. tube, bottle, etc.)

b) outer packaging (folding box)

• Directions for use

Drugs can be distributed in Austria only after being authorized for Austria (or the EU – authorization is binding for all member states).

In order for the authorization to be granted, documentation regarding the quality, effectiveness and safety of the drug must be submitted

The authorization is only granted if the responsible authority deems the risk-reward relationship to be positive.

During the authorization process, the content of the SPC (summary of product characteristics) and directions for use as well as the labeling are determined and must be approved.

2. Which authority is responsible for the authorization of pharmaceutical products?

BASG (Bundesamt für Sicherheit im Gesundheitswesen – Austrian Federal Agency for Safety in Healthcare). Ap-plications for authorization, applications for clinical tests, notifications of side effects, and any other relevant in-formation must be submitted to this authority. It is also responsible for issuing authorization notification.

These applications are then transferred to AGES PharmMed, which is responsible for processing them and for corresponding with the applicant during the processing. After the processing has been completed, BASG, as the official body, issues the authorization

AGES PharmMed is the branch of the Austrian Agency for Health and Food Safety, AGES (Oesterreichische Agentur fuer Gesundheit und Ernaehrungssicherheit GmbH), which is responsible for pharmaceuticals. It com-prises seven divisions responsible for the following areas:

• OMCL (Official Medicines Control Laboratories)
• Authorization & Lifecycle Management of Medicinal Products
• Inspections
• Pharmacovigilance
• Pharmacovigilance
• Controlling & Services
• Science & Information

For a complete diagram of the structure of AGES PharmMed and its department heads, please see :

Diagram

Further information (in English) about AGES PharmMed can be found at

Contacts

BASG – Bundesamt für Sicherheit im Gesundheitswesen
Schnirchgasse 9
A-1030 Wien
Austria
Chair: Dr. Hubert Hrabcik

AGES PharmMed
Schnirchgasse 9
A-1030 Wien
Austria

General information and inquiries:

Mrs. Carmen Ofner
Tel: +43 (1) 42707-101
OMCL (Official Medicines Control Laboratories):

email:carmen.offner@N0SPAM.ages.at

Dr. Gerhard Beck
Schnirchgasse 9
A-1030 Wien
Austria
email:gerhard.beck@N0SPAM.ages.at

Authorization & Lifecycle Management of Medicinal Products:

Mrs. DI Dr. Christa Wirthumer-Hoche
Tel: +43 (0) 50 555-36500
OMCL (Official Medicines Control Laboratories):

email:christa.wirthumer-hoche@N0SPAM.ages.at

Inspections:

DDr. Alexander Hoenel
Tel: +43 (0) 50 555-36400

email:alexander.hoenel@N0SPAM.ages.at

Pharmacovigilance & Medical Devices:

Dr. Reinhard Berger
Tel: +43 (0) 50 555-36200

email:reinhard.berger@N0SPAM.ages.at

Quality Management:

Mr. Mag. Werner Steininger
Tel: +43 (0) 50 555-36700

email:werner.steininger@N0SPAM.ages.at

Science & Information:

Ms. Ao.Univ.Prof. Dr. Andrea Laslop
Tel: +43 (0) 50 555-36800

email:andrea.laslop@N0SPAM.ages.at

For deliveries containing samples and data concerning marketing surveillance of medicinal products:

AGES PharmMed
OMCL
Zimmermanngasse 3
A-1090 Wien
Austria

For deliveries concerning batch release and plasma pool testing and the related documentation:

AGES PharmMed
OMCL
Possingergasse 38
A-1160 Wien
Austria

3. Which forms do I need in order to apply for authorization?

All required forms can be obtained from AGES PharmMed at

http://www.ages.at/servlet/sls/Tornado/web/ages/content/0096D1A8CA69F5C4C12570D5002C02BE

The available forms are subdivided into the different divisions of PharmMed and can be accessed by clicking on the relevant area (division of AGES) on the menu.

The forms and website are only available in German.

The forms required for application for authorization can be found at

http://www.ages.at/servlet/sls/Tornado/web/ages/content/E1FC19A9A2D95D18C12570D5002C02C0

Additional forms must be submitted shortly before authorization to the relevant contact person at AGES. The final version must then be sent to spc@N0SPAM.ages.at . These forms are FI/GI/KE (Fachinformation – SPC, Gebraucherinformation – directions for use, and Kennzeichnung – labeling). They can be found at http://www.emea.europa.eu/htms/human/qrd/qrdplt/H01a-DE-SPC-II-lab-pl.doc . The set of three forms is a single document. However, the three forms must be submitted separately to AGES.

4. Can I submit the application in English?

No. Forms are only available in German and the official language of subsequent correspondence is only German.

5. Can I submit the documentation required for the application in English?

Additional documentation to be attached to the application forms (e.g. test results) can be sent in English. How-ever, as mentioned above, the forms must be filled out in German.

6. Is there an English version of the Austrian Law on Pharmaceutical Products?

Yes, there is an English Version of the AMG (Arzneimittelgesetz). It can be ordered from Pharmig (Association of Pharmaceutical Companies) by submitting the Faxorder (29KB)

7. Where do I send the application?

Bundesamt für Sicherheit im Gesundheitswesen
Institut: Zulassung & Lifecycle Management
Schnirchgasse 9
A-1030 Wien
Austria

8. Can I apply for authorization online?

Yes. However, this can only be done by following e-CTD (electronic Common Technical Document) regulations. Information can be found at http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2a . Please note that standardized software, databases, etc. are required for this type of application, though. Some applicants use this method, however, most apply using the CTD-form, i.e. the hardcopy (CD-ROM or DVD is preferred). Applications cannot be sent via e-mail as attachments.

However, texts provided in the forms FI/GI/KE (Fachinformation – SPC, Gebraucherinformation – directions for use, and Kennzeichnung – labeling) mentioned above shall only be submitted to the relevant contact person after prior agreement, and shortly before authorization of the new product. After coordination with the contact person, the final document must be sent to spc@N0SPAM.ages.at .

These FI/GI/KE forms can be found at http://www.emea.europa.eu/htms/human/qrd/qrdplt/H01a-DE-SPC-II-lab-pl.doc. The set of these three forms is a single document. However, they must be submitted separately to AGES.

9. How many copies of the application do I have to submit?

For electronic registration (e-CTD):

Two hard copies of Module 1. Further hard copies are to be submitted on request.

For mail registration:

Submission by CD-ROM or DVD is preferred.

Two hard copies each of Module 1 and 2. Hard copies of Modules 3, 4 and 5 are to be submitted upon request.

10. Which additional documents must be submitted?

The additional documents to be submitted with each form and the number of copies required are indicated on the form itself.

11. How much does the authorization cost?

National authorization:

• New API (active pharmaceutical ingredient): EUR 10,700.00
• Known API: EUR 7,000.00
• Bio-similar and bibliographic application: EUR 5,600.00
• Generic medicinal product: EUR 4,200.00
• New combinations: EUR 7,000.00

These are just a few of a very large number of different fees. The entire list of fees (renewal, import, EU registra-tion, etc.) can be found (in German) at http://www.ages.at

12. When and how do I pay?

Fees must be submitted by electronic bank transfer. Checks are not accepted.

Bank details:

Bank Austria-Creditanstalt
Account no: 50670 871 619
Bank/sort code (Bankleitzahl): 12000
IBAN: AT971200050670871619
BIC/SWIFT: BKAUATWW

The applicant receives an invoice with a client ID and an invoice number. These two pieces of information must be included in all bank transfers. Costs for transfers are paid by the applicant.

No fees are to be transferred before the application has been submitted. After the formal requirements have been assessed and the documents have been submitted, a fee payment order is issued.

If the application is recalled before the completion of the assessment of the formal requirements, 10% of the esti-mated fee is to be paid. If it is recalled after this time, the complete fee must be paid.

13. How long does the authorization process take?

The processing time alone is seven months. However, this does not include time-out periods, i.e. when docu-ments and/or tests are missing or incomplete. These must be submitted and the extra time required is added on to the seven months needed for processing.

14. Is it necessary to have an Austrian subsidiary or branch?

No. However, if there is none, there must be a subsidiary or branch in another EEC member state; authorization for companies based only in the United States is not possible. Having an Austrian representative does make the Austrian application procedure easier, since the working language during the authorization process is German.

15. Does prior FDA (U.S. Food and Drug Administration) approval influence the authorization by Austria?

No. Austrian regulations are stricter than those of the FDA, and therefore products must be inspected and tested in the same way that new Austrian products are.

16. Does the authorization expire?

Yes. The authorization is valid for only five years. However, authorization can be renewed. The forms relevant for renewal can be found at http://www.ages.at/servlet/sls/Tornado/web/ages/content/E1FC19A9A2D95D18C12570D5002C02C0

17. What are the scientific requirements for pharmaceutical products?

It is prohibited to produce or distribute drugs that do not reflect the current state of scientific knowledge.

18. How are clinical tests conducted?

Clinical tests are conducted before a pharmaceutical product is authorized. These tests involve the systematic examination of a drug on humans in order to

• discover or verify the effect and effectiveness
• identify undesirable (side) effects
• examine absorption, dispersion, effect on metabolism and elimination of the drug in order to ensure the effectiveness and harmlessness of the drug.

Clinical tests may only be conducted if

• their goals satisfy the objectives mentioned above
• information about relevant physical and chemical data or biological characteristics as well as the technol-ogy employed is available
• their goals satisfy the objectives mentioned above

The sponsor, monitor and examiner work together to conduct the clinical tests. However, in general the sponsor is put in charge of the testing. The specific responsibilities of each are regulated by the AMG ( (Arzneimittelgesetz - Law on Pharmaceutical Products). Their main responsibilities are the following:

• The sponsor is responsible for acquiring detailed SOPs (standard operating procedures) and for ensuring that the tests comply with them.
• The monitor is responsible for establishing communication between sponsor and clinical examiner. He or she must be qualified for specialized supervision of the clinical tests.
• The examiner may only be a physician or dentist, licensed to practice medicine in Austria, who has rele-vant experience and knowledge about clinical tests and the intended area of indication.

Every clinical test must follow a testing plan that ensures that evaluation and replication of the results are possi-ble. Details for the planning, conducting and evaluation are also regulated by the AMG (Arzneimittelgesetz – Law on Pharmaceutical Products).

Clinical tests must be conducted in compliance with the AMG (Arzneimittelgesetz - Law on Pharmaceutical Products). The regulations of GCP (Good Clinical Practice) must also be followed.

19. What is the registration number used for?

It is required for the BASG pharmaceutical products register. Every authorization, and every amendment or can-cellation of an authorization, has to be recorded in this register.

The registration number has six digits. The first digit indicates what type of pharmaceutical product it is: Numbers 1 to 7 indicate preparations for human use; number 8 is for veterinary use.

Along with the registration number, the following must be listed in the BASG pharmaceutical products register:

• name of the product
• holder of the authorization
• areas of application
• composition with respect to the active ingredients
• packaging sizes
• shelf life
• information regarding distribution (i.e. prescription required)

20. What are the regulations on misleading information?

It is prohibited to distribute drugs

• whose name or packaging could mislead users
• about which misleading claims are made (e.g. incorrect information about effectiveness or healing proper-ties).

21. Is there a specific import analysis or quality control procedure for pharmaceutical products originating from the United States?

No. There is a bilateral agreement with the United States, which eliminates the requirement for a complete quality and quantity control. The latter would otherwise be necessary for products imported from countries outside the EEC (European Economic Community).

22. What are the conditions for obtaining an import license?

Pharmaceutical products which have not been authorized in Austria require an import license. This license is only granted under the following conditions:

• The product is intended for re-export
• The product will be used for scientific purposes only (e.g. lab analysis), and will not be administered to humans
• The product will be used in clinical tests or for similar medical research, and only in this context will it be administered to humans or animals

23. Which drugs can be imported without an import license?

• Authorized pharmaceutical products (nationally or EU-centrally)
• Pharmaceutical products not requiring authorization (e.g. those intended for a military mission)
• A product for which a doctor has submitted an attestation that the drug is needed for an urgent (for exam-ple a life-threatening) case, and a similar product is not available in Austria
• Drugs needed in the event of a disaster
• Drugs that have been granted licenses under the Animal Epidemic Law

24. Can unauthorized drugs be imported?

Yes. Import licenses can be granted for unauthorized drugs which otherwise would require authorization. How-ever, the license is only granted on the following conditions:

• The drug will be used for clinical or non-clinical tests
• The drug is needed in an instance in which pharmaceutical products authorized in Austria are not suffi-cient for the effective treatment of humans or animals. Here a specialized or scientific justification must be given by the doctor or veterinarian.

In general, import licenses are only granted if there are no health-related concerns regarding the drug.

25. What are the regulations regarding advertising of pharmaceutical products?

• authorized pharmaceutical products
• registered herbal pharmaceutical products
• registered homeopathic pharmaceutical products
• pharmaceutical products imported from a lower priced to a higher priced country, which is a member of the EEC (“parallel-imported” [sic])
• pharmaceutical products authorized specifically for pharmacies

It is prohibited to advertise pharmaceutical products that have not been authorized (except at international con-gresses).

The advertisement must present the product’s characteristics objectively and without exaggeration. Thus, neither wording nor graphic representation may

• promise effects that are not authorized
• promise regular or guaranteed effectiveness
• display information contradicting the product’s labeling, SPC (summary of product characteristics) or di-rections for use.

Comparison advertising is allowed, however, deprecatory or false advertising is not.

Non-specialized advertising to the general public (in magazines, on TV or the radio, on billboards, etc.) is only allowed for Over The Counter (OTC) pharmaceutical products.

It is prohibited to portray or imply the endorsement of healthcare professionals, healthcare authorities, or celebri-ties in advertising in order to encourage the use of a pharmaceutical product. Similarly, it is prohibited to show a bodily injury in advertising for the purpose of dramatizing the positive effect of a product.

Specialized advertising may only be used in literature distributed to healthcare professionals (i.e. doctors, hospi-tals) and may not be aired on TV or the radio.

26. How are pharmaceutical products distributed?

The product follows a particular distribution-chain in order to get from the manufacturer to the patient: manufacturer – wholesale – public pharmacy or hospital pharmacy – patient.

Some physicians maintain a small pharmacy. (They are called self-dispensing doctors.) These doctors can only purchase the drugs from public pharmacies.

Exceptions to the above rule: OTC products listed in the “classification regulation” (Abgrenzungsverordnung) can also be sold in drug stores. For details please go to http://www.apotheker.or.at/internet/OEAK/NewsPresse_1_0_0a.nsf/agentEmergency!OpenAgent&p=C6B3051E2CC8CE0CC1256E58002CE405&fsn=fsStartHomeFachinfo&iif=0

27. Can pharmaceutical products be sold via the Internet?

No. It is prohibited to distribute pharmaceutical products via self-service outlets (retails stores and vending ma-chines) or via the Internet in Austria. However, this is not necessarily the case in other EEC countries.

28. What must be indicated on the packaging?

Authorized pharmaceutical products may only be distributed if they are labeled correctly.

The labeling must

• be clearly legible, with a font size of at least 1.8 mm
• be an integral part of outer and primary packaging, i.e. not removable

The labeling must contain the following:

• name
• holder of the authorization
• authorization number
• composition (active ingredients and excipients)
• volume
• pharmaceutical form or category
• method of application
• batch number
• expiration date
• warning about children

Additionally the following (according to the type of pharmaceutical product) may be required:

• indication of availability in pharmacies only
• indication of availability with prescription only
• description of the effect on reaction time (e.g. on ability to drive after taking the product)
• method of administration or application (e.g. serums, vaccines)
• homeopathic effects
• indication of use by veterinarians
• wait time before using an animal for food production after administering the drug
• batch clearance information
• radioactivity information
• information on proper storage
• name of the parallel importer

All of the regulations mentioned above are contained in the AMG (Arzneimittelgesetz – Law on Pharmaceutical Products) and the Labeling Regulation (Kennzeichnungsverordnung) .

The name of the pharmaceutical product as well as the dosage must be indicated on the packaging in Braille. The “Marburg Medium” is suggested as a standard for the distance between and height of dots. Literature Braille (not computer or abbreviated Braille) should be used.

Exceptions to the above rule on Braille are:

• analgesic products
• registered homeopathic medicines
• products only to be used by physicians and trained personnel (vaccines, intravenous solutions, etc.)
• small packages (less than 10 ml) – abbreviations of the required information can be applied for
• packages with more than one language – any names that are different must be printed in Braille as well

Further information and specifications on using Braille can be found at

http://www.ages.at/servlet/sls/Tornado/web/ages/content/D34CCE768F9CED01C12571390034CDFB#14

29. What must be included in the directions for use?

Authorized pharmaceutical products may only be distributed if the packaging contains directions for use. These directions are meant for the user, and the information they contain is based on the SPC (summary of product characteristics).

The information must be detailed enough to ensure safe, effective, appropriate and harmless use. Everything must be clear and legible (using a font size of at least 1.8 mm.

The directions for use must contain at a minimum the following:

• name, pharmaceutical form or category
• authorization number
• manufacturer
• composition, i.e. ingredients
• characteristics and effectiveness
• areas of application
• method of application
• strength, concentration and directions on dosage
• contra-indications (circumstances when the drug should not be used)
• side effects
• interaction with other products
• warning on risk of addiction
• other relevant warnings
• warning to “keep out of reach of children” ("Für Kinder unerreichbar aufbewahren")
• available packaging sizes
• date when directions for use were issued or altered

Pharmaceutical products that are definitely not going to be given to patients (e.g. radioactive pharmaceuticals, narcotics) do not need to contain directions for use.

30. What must be included in the SPC (summary of product characteristics)?

The SPC (Fachinformation) must be available for experts and specialists in the field, i.e. doctors, veterinarians, dentists, pharmacists, business owners (manufacturers, and also those allowed to distribute pharmaceuticals, e.g. drug stores, op-ticians).

The Austrian Chamber of Pharmacists works with the Chamber of Physicians to publish the SPC in the so-called “Austria Codex Fachinformation”. The SPC is also made available in other publications, such as “Vidal”. Health-care specialists must have access to up-to-date SPC information at all times.

The SPC must contain at least the following information:

• name of pharmaceutical product and its strength
• composition, i.e. ingredients
• pharmaceutical form or category
• clinical information ( area of application,strength, concentration and instructions on dosage,method of application, o specific warnings and precautionary notices, contra-indications, instructions for use during pregnancy and while nursing an infant, side effects,effects of and remedy in case of overdose, pharmacological characteristics, pharmaceutical characteristics
• name and address of the holder of the authorization
• authorization number
• date of the first authorization
• date of SPC
• specific warnings and precautionary notices for radioactive products

31. What is the procedure for registering a pharmaceutical product in another EU (European Union) country?

As soon as more than 1 EU country is involved in the registration, EU regulations apply. There are some differ-ences, but in general the requirements (for product quality, effectiveness and safety) for the Austrian national au-thorization are based on the EU regulations for authorization.

The Austrian authorization process is regulated by the AMG (Arzneimittelgesetz – Law on Pharmaceutical Products).

The EU authorization requires that the authorization be carried out using the same criteria in every country and that, in the end, the SPC (summary of product characteristics) is identical in all countries.

There are two types of authorization procedure: the local and the central.

Local authorization procedure (= procedure of mutual approval):

1. An RMS (Reference Member State) examines the drug.
2. Other member states, that will also be authorizing the drug – they are termed CMS (Concerned Member State) – inspect the application based on the appraisal of the RMS.
3. For a product to be authorized, it must be authorized by the RMS and all CMSs.
4. If the authorities of the RMS and CMSs cannot agree, the drug cannot obtain EU-wide authorization.

Central authorization procedure:

1. The EMEA(European Medicines Agency) in London, not the individual member states, examine the drug and the application for authorization.
2. Based on the EMEA’s appraisal, the EU Commission issues an EU-wide authorization, which is binding for all member states.
3. This procedure is mandatory for several pharmaceutical products (including drugs produced by using ge-netic or bio technology, and new drugs for use against AIDS, cancer, diabetes and asthma). For other drugs the applicant can choose between the local and the central procedure.

For more information on registering a product in the EU please see

http://www.emea.europa.eu/index/indexh1.htm

32. How do I find out whether to apply for authorization of the product as a pharmaceutical product or a food supplement?

There are consulting companies that can determine which category your product falls under, after examining it (its ingredients, its strength etc.). This saves you time and can enable you to submit the correct form to the BASG. These companies can also help you with the further application process.

Contacts:

Agneter Pharma Consulting GmbH
http://www.pharmaconsulting.at/
Contact: Univ. Doz. Dr. Ernst Agneter, MBA

Dr. Robert Heinz & Partner GmbH
http://www.heinz-consulting.com/en/index2.htm
Contact: Dr. Christian Wolflehner

INFO-Service
http://www.info-service.cc/
Contact:Contact: Ms. Karin Herzele

NetContact OEG, Pharma-Consulting
http://www.netcontact-oeg.at/
Contact: Dipl.Ing. Josef & Eva Maria Schwarz

Pharma Consulting Dr. Heimo Stroissnig
http://www.pharmaconsult.at/
Contact: Dr. Heimo Stoissnig

Vetcom BT
http://www.vetcom.at/
Contact: Dr. Mag. med.vet. Eszter Aykler

ZAK – Pharma Dienstleistung Ges.m.b.H
http://www.zakpharma.at/
Contact: : Jean-Jacques Chirikdjian

There is also an authority, the Abgrenzungsbeirat (Classification Committee), that determines whether a drug is a pharmaceutical product or a food supplement, for example. An applicant may submit a form to that office, which then determines what product type the drug falls under. The relevant form can be found at http://www.ages.at/servlet/sls/Tornado/web/ages/content/E1FC19A9A2D95D18C12570D5002C02C0.

Questions regarding the classification of drugs can also be sent to the same office at the following email address:

abgrenzung@N0SPAM.ages.at

To avoid the somewhat more bureaucratic procedures of the Classification Committee, applicants may prefer to use a consulting company.

33. What is the difference between the application for the authorization of a food supplement and the applica-tion for the authorization of a pharmaceutical product?

The laws that apply to the two different types of product are completely different, as are the authorization re-quirements for each.

The AMG (Arzneimittelgesetz – Law on Pharmaceutical Products)is the relevant law applying to the authorization of pharmaceutical products.

The LMSVG (Lebensmittelsicherheits- und Verbraucherschutzgesetz – Food Safety and Consumer Protection Law) applies to food supplements. The EU Directive2002/46/EC on food supplements has been incorporated into Austrian law.

Food supplements can be distributed in Austria without being authorized or registered beforehand. Every com-pany distributing food supplements is responsible for ensuring that the products comply with the legal require-ments of the Food Safety Law.

34. What are the regulations for food supplements?

• The only ingredients food supplements may contain are single or multiple nutrient (vitamins and minerals) concentrates or other substances that are not vitamins or minerals, but have a physiological effect.
• The types of vitamin and mineral combinations that are permitted in food supplements are regulated throughout the entire EU by the Directive2002/46/EC on the Approximation of the Laws of the Member States Relating to Food Supplements.
• Maximum amounts of vitamins and minerals in food supplements, as well as the addition of substances that are neither vitamins nor minerals, are still regulated on a national basis. A list (PDF file) of these can be found at the bottom of the following site http://www.apotheker.or.at/internet/OEAK/NewsPresse_1_0_0a.nsf/agentEmergency!OpenAgent&p=C6B3051E2CC8CE0CC1256E58002CE405&fsn=fsStartHomeFachinfo&iif=0.
• There is no restriction as to who can distribute food supplements (retailers include pharmacies, drug stores, and also supermarkets).
• § Advertisement for foodstuffs and therefore also food supplements may not be misleading and must con-vey the truth. Furthermore, it may not be illness-related, i.e. may not contain claims about prophylaxis, treatment or cure for a human illness or give the impression it might have these effects.

35. Which authorities are involved in the regulation and distribution of food supplements?

The Bundesministerium für Gesundheit, Familie und Jugend (Ministry of Health, Family and Youth), http://www.bmgfj.gv.at/ is responsible for legislation.

AGES as well as authorized foodstuffs experts and evaluators are responsible for the evaluations of distribution.

36. Is there a different application form for traditional herbal medicines?

Yes. The relevant form can be found here (Austrian Health and Nutrition Agency). As for other pharmaceutical products, an Austrian (or other EEC member state) subsidiary is required in order to apply for authorization.

37. What are the requirements for registering a product as an herbal medicine?

• The areas of application must be only those for which herbal medicine is traditionally used.

•The product must be designed to be an OTC product based on its ingredients and its purpose.

• The product must be designed to be applied in only one available strength and dosage.

• An equivalent product must have been used for medical purposes for at least 30 years, of which at least 15 years must have been in the EEC.

• In the declaration on the traditional usage of the products, its harmlessness and the plausibility of its ef-fectiveness must be sufficiently documented (with bibliographic information or a specialist’s report).

• For a product that is a combination of vitamins and minerals, or if the product contains more than one ac-tive ingredient, information about the combination of the intgredients must be submitted.

• The contact information of a person responsible for pharmacovigilance, proof of the necessary infrastruc-ture, a description of how pharmacovigilance is conducted and evidence that a risk management system is in place must be submitted.

38. What are the pharmaceutical industry’s main industry organizations and interest groups?

In Austria there are two types of interest groups in this sector: those with mandatory and those with optional membership.

Mandatory groups (chambers):

• Chamber of Physicians (Ärztekammer) - http://www.aek.or.at/

• Chamber of Pharmacists (Apothekerkammer) - http://www.apotheker.or.at/

• Chamber of Commerce (Wirtschaftskammer) - http://wko.at/awo/chamberinfo.htm , pharmaceutical companies are represented in three sections in the Chamber: business, manufacturing, and trade

Optional groups (associations, unions):

• ARGE Pharmaceuticals: Pharmaceutical wholesale (Vereinigung der Pharmazeutischen Vollgrosshaendler Österreichs) - http://www.argepgh.at/arge.htm

• IGEPHA: Austrian Self Medication Industry (Interessensgemeinschaft Österreichischer Heilmittelhersteller und Depositeure) (OTC) http://www.igepha.at/

•PHARMIG: Association of pharmaceutical companies (Verband der pharmazeutischen Industrie Österreichs) - http://www.pharmig.at/modules.php?name=Content&home=1&SESS=37f836f2d3bf2d2fdb8c672704f84ac4

•FOPI: Forum for the Pharmaceutical Industry involved in research (Forum der Forschenden Pharmazeutischen Industrie) - http://www.fopi.at/page.asp/86.htm

• ÖGB: Austrian Labor Union Alliance (Österreichischer Gewerkschaftsbund) -http://www.oegb.at/servlet/ContentServer?pagename=OEGBZ/Page/OEGBZ_Index&n=OEGBZ_0

• Federation of Austrian Industrialists (Industriellenvereinigung) http://www.industriellenvereinigung.at/