- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
Administrative regulation 9/93  regulates the status of herbal products in Finland. It takes into account the provisions of Directives 65/65/EEC  - especially article 4.8 (a) (ii), 75/318/EEC , and 75/319/EEC  with later amendments. Herbal products contain traditionally used plants or their parts as such or in dried form, extracts or tinctures prepared from them, or traditionally used essential or fatty oils.
In accordance with the European Directive 75/319/EEC , an expert report shall be submitted on the pharmaceutical and chemical characteristics. With regard to these, a summary based on the application material shall be submitted which briefly describes the main indications for the products, the usual dose, mechanism of action, side effects, interactions with other medicinal products, and other facts which the manufacturer considers to be of significance in the evaluation of the application .
The documentation on pharmaceutical and chemical characteristics shall be presented in accordance with the European Directives 75/318/EEC  and 91/507/EEC  which are applicable for all kinds of medicinal products. The particulars on the quality and manufacture of herbal remedies shall further take into account the European guideline "Quality of Herbal Remedies". Raw materials have to meet the requirements of the pharmacopoeia or, if there are none, detailed quality requirements shall be drafted in accordance with the model of the monographs of the European Pharmacopoeia. Quality requirements for intermediate and finished products have to be presented, the latter covering, for example, identification and determination of active ingredients with validated methods, and a purity test. If the product contains more than one herbal remedy, these shall all be identified e.g., by the TLC finger print method.
The applicant shall present a proposal for the indications of the product, its dosage and, where necessary, its instructions for use. If the herbal remedy or its active ingredient has been used for a long time in Europe or in countries close to Europe with regard to their health care traditions, the safety and proposed indication of the product can normally be explained by information available in scientific literature, which shall be verified in accordance with the European Directive 91/507/EEC . If this cannot be reliably verified, an application for a marketing authorization with a full dossier shall be made. Where a bibliographic application is made, copies of the references in the scientific literature verifying the safety and indications of the product shall be submitted. The application shall also include a bibliography of the material that is appended or otherwise referred to in the application. Proposals for labelling and the package leaflet and the Summary of Product Characteristics shall be submitted to the National Agency for Medicines together with the application. The label of a herbal remedy clearly states that it is a herbal remedy .
Herbal products are normally sold in pharmacies with the exception that, if they are not registered as medicines, they can be sold as health products in pharmacies, department stores and health shops .