Traditional Herbal Medicinal Products

1. In which form should the documents be submitted?

Applications for the registration of a traditional herbal medicinal product should be submitted in accordance with the Austrian Medicines Act (Arzneimittelgesetz, AMG) as amended. The documents to be submitted as part of the application for registration are specified in Article 12a AMG, and they should be submitted in CTD format.

2. Which application form should be used for the registration of a traditional herbal medicinal product?

Please use the form available on the website of the Austrian Federal Office for Safety in Health Care. Choose
“F Z13 Antrag Registrierung.doc” (Application form for the registration of a traditional herbal medicinal product).

3. Under which conditions can a medicinal product be registered in accordance with Article 12 AMG?

The applicant has to demonstrate the following:
The indications are exclusively appropriate to traditional herbal medicinal products. The medicinal product is, by virtue of its composition and purpose, designed for use without prescription. The medicinal product is exclusively designed for administration in accordance with a specified strength and posology. A corresponding product has been in medicinal use throughout a period of at least 30 years, including at least 15 years within the European Economic Area. The data on the traditional use, including safety and plausibility of efficacy, are sufficient. The traditional use can be demonstrated either by bibliographical data or by means of an expert report. No additional demonstration of the traditional use is required when a reference is made to a Community Monograph according to Article 16(h)3 of Directive 2001/83.

For combinations with vitamins or minerals and for medicinal product containing more than one active ingredient, data on the combination should be provided. In case traditional use has been demonstrated for the combination, but not for the single active substances, data on the single active substances should be provided.

Evidence of a person responsible for pharmacovigilance; description of the pharmacovigilance system and (if appropriate) the risk management system.
Details are given in Articles 12 and 12a AMG.

4. What is a ‘corresponding’ herbal medicinal product in accordance with Article 12a AMG?

A corresponding herbal medicinal product has the same active ingredient, the same or similar indications, an equivalent strength and posology, and the same or a similar route of administration, as the herbal medicinal product which is submitted for registration.

The phrase ‘same active ingredient’ is somewhat difficult to interpret, especially with respect to extracts from herbal drugs. However, what is clear is that ‘same active ingredient’ means the same plant, plant part, and extraction solvent; moreover, a similar concentration of the extraction solvent (especially with water-alcohol mixtures) and a similar drug-extract ratio are required. Overall, therefore, the traditional herbal medicinal product must be closely related to published data or to other medicinal products.

5. Can an extract whose efficacy and safety has previously been demonstrated in clinical studies performed according to GCP be registered with the same indications as a traditional herbal medicinal product?

No. In this case, either a bibliographic application (“well–established use”) or a full application will have to be submitted.

6. How can the evidence of traditional use be demonstrated?

Evidence of traditional use can be demonstrated through any form of scientific documentation. Also, it is important to document that the medicinal use of the product has not been just sporadic, but that the product has been used continuously over longer periods within the requested 30 years.

7. What are the requirements with respect to the quality of traditional herbal medicinal products?

The quality aspect of a medicinal product is independent from whether it has a traditional use. Therefore, no exemptions can be made with respect to the physicochemical, biological, and microbiological data to be submitted.

Traditional herbal medicinal products may contain herbal drugs which are not the subject of a pharmacopoeia monograph and for which only limited analytical procedures have been published. Therefore, the quality of traditional herbal medicinal products must be determined on a case-by-case basis, taking into consideration its composition and the analytical procedures available to document its quality.

8. Are stability tests necessary for traditional herbal medicinal products?

Yes, stability tests are necessary both for the active substance(s) and for the finished product. The data have to be submitted as part of the registration dossier. When adequate instructions for storage are foreseen, stress tests at higher temperatures may be waived.

The selection of adequate analytical markers may be difficult, especially for preparations containing several herbal drugs. The applicant should try to document that the extracts in their totality are sufficiently stable.