Efficacy and Safety (Module 4 and 5)

The documentation that describes efficacy and safety of a product is called non-clinical and clinical documentation (Module 4 and 5 of the dossier). Herbal medicinal products can be approved by a full or a bibliographic application, in the same way as conventional drugs. If the requirements for efficacy and safety documentation cannot be met in the same way as for conventional medicinal products it may be possible, for medicinal products for human use, to register a product based on traditional medicinal use.

Full application (product-specific efficacy and safety)

An application in accordance with the documentation requirements in Chapter 3 of the MPA’s provisions (LVFS 2006:11) on marketing authorisation for medicinal products (Article 8 of Directive 2001/83/EC) is a so called full application.
Efficacy and safety shall be demonstrated by data from product specific non-clinical studies and clinical trials in the same way as for conventional medicinal products. Read more in the EMA collection of non-clinical and clinical guidelines in the right pane menu.

Bibliographical applications / Well-established medicinal use (efficacy and safety data published in scientific literature)

For herbal medicinal products that have a documented medical use for at least ten years in the EEA application may be made in accordance with well-established medicinal use in the same way as for conventional medicinal products with well established medicinal use (application in accordance with the documentation requirements in Chapter 5 Section 6 and 7 LVFS 2006:11 (Article 10a of Directive 2001/83/EC)). Product-specific efficacy and safety data (pre-clinical and clinical data) can be replaced with information on "well established medicinal use" of the corresponding plant / plant preparation in the EEA for at least ten years, which is supported by scientific literature.

Traditional use

For traditional herbal medicinal products that have a documented medicinal use for 30 years (including at least 15 years within the EEA), a simplified application, without efficacy data (clinical trials) can be made. Safety of the product should be displayed and evaluated with relevant literature data, and supplemented by product-specific studies should essential data be missing.

EMA guidelines describe how the traditional use should be demonstrated. Herbal substances / herbal preparations included in the Commission's list of herbal substances, preparations and combinations thereof (Commission list entries) have demonstrated traditional use (see below).

Union herbal monographs

The European Commission adopts, on the proposal of HMPC (Committee on Herbal Medicinal Products at the European Medicines Agency) a list of herbal substances and preparations which may be part of traditional herbal medicinal products. For substances / preparations listed in the Commission list entries it is considered that traditional use and safety has been demonstrated and reference to the list may substitute efficacy and safety documentation. The list is binding, national authorities may not derogate from the Commission's decision. More information is available under Union Herbal Monographs in the left pane menu.

Commission list entries

The European Commission adopts, on the proposal of HMPC (Committee on Herbal Medicinal Products at the European Medicines Agency) a list of herbal substances and preparations which may be part of traditional herbal medicinal products. For substances / preparations listed in the Commission list entries it is considered that traditional use and safety has been demonstrated and reference to the list may substitute efficacy and safety documentation. The list is binding, national authorities may not derogate from the Commission's decision. More information is available under Union Herbal Monographs in the left pane menu.

 
 
 

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