Natural remedies and Traditional Herbal Medicinal Products may be placed on the market only if they have been authorised by the Medical Products Agency. An authorisation is valid for five years after which it must be renewed. A herbal medicinal product can be authorised, like any other medicinal product, after submission of a full application according to either Article 8 in the Directive 2001/83/EC (PDF) or to Article10 a from the same Directive. (Notice to Applicants)
Application
Applications must be made according to the CTD format and the same form that is used for conventional medicinal products should also be used for natural remedies and traditional herbal medicinal products. It has to be clearly indicated in the covering letter that the application is regarding an approval as a natural remedy or as a traditional herbal medicinal product.
The application should be sent to the Medical Products Agency with the reference documentation enclosed. The application fee will be invoiced to the applicant. The application and the enclosed documentation should be in either Swedish or English. The Medical Products Agency will assess the application with regard to quality, safety and efficacy (see below). After an application for approval is received, normally a maximum of three injunctions for supplementary documentation (denials) are sent, unless special circumstances apply, before a final decision is made.
Quality
The quality documents are to be compiled according to the guidelines that apply to regular medicinal products, i.e. "Notice to Applicants", Volume 2 (EudraLex.) The guidelines can be downloaded from the website of the Pharmaceuticals Unit of the European Commission. The quality requirements are generally the same as for conventional medicinal products. Guidelines and requirements can be found in documents published by the CPMP (Committee for Proprietary Medicinal Products), a sub-committee of the European Medicines Agency, EMEA. A copy of a valid manufacturing license that supports that the manufacturing processes adhere to the GMP standard should be enclosed.
Efficacy and safety for natural remedies
Efficacy and safety can be documented in two different ways. A bibliographical application may be submitted if the use of the product is well-established and documented. This means that for products with a well established use, full documentation of the results of pharmacological and toxicological investigations or clinical trials may be replaced by data from published scientific literature. If there is not enough bibliographical data available, the efficacy and safety must be documented based on the applicant’s own studies. The guidelines for clinical trials for natural remedies are the same as for conventional medicinal products. For more information, e.g. about the documentation that should be enclosed in an application, please refer to LVFS 1995:18 (PDF).
Efficacy and safety for traditional herbal medicinal products
To fulfil the requirements regarding safety and efficacy the applicant must be able to verify that the product in question or a corresponding product has been used for medicinal purposes for a period of at least 30 years at the time of the application, including at least 15 years of use within the European Union. For further information regarding variations, renewals see links under Medicinal Products.