Workgroups of the Council on the Community Code and the European Parliament’s have conducted an overview and revision of legislations relating to medicinal products. Agreement was reached in the spring of 2004 concerning changes in the directives and regulations, as well as adding special provisions for so-called traditional herbal medicinal products. In Sweden, an amended Medicinal Products Act and its accompanying regulatory took effect in May 2006. The Medical Products Agency’s regulation (LVFS 2006:3) for traditional herbal medicinal products was adopted on 2 May 2006.
Herbal Medicinal Products (Växtbaserade läkemedel)
The concept “herbal medicinal products” was introduced into Swedish legislation already in October 2003 (LVFS 2003:7). Herbal medicinal products may be authorised similarly to other medicinal products.
Traditional Herbal Medicinal Products (Traditionella växtbaserade läkemedel)
Special provisions have been added to the amended medicinal products directive concerning so-called traditional herbal medicinal products. Concerning traditional herbal medicinal products (2004/24/EC) a simplified registration procedure has been introduced (and not authorization, as for other medicinal products). It was decided to set the requirements for documentation quality at the same level as for medicinal products, i.e. a complete dossier.
The therapeutic indications are strictly limited to self-care indications that do not require a physician’s diagnosis, prescription, or treatment monitoring. The preparations may only be intended for oral use, external application and/or inhalation.
Concerning the efficacy documentation, the requirement is that the applicant shall be able to demonstrate that the medicinal product in question, or a corresponding product, has been in medicinal use throughout a period of at least 30 years preceding the data of the application, including at least 15 years within the Community. To document safety, a review and evaluation of the relevant safety date in the literature is required, or if such is absent, supplementation with original research. This is specified in Articles 16a through 16h of Directive 2001/83/EC.
The Committee on Herbal Medicinal Products
The directive further orders that a Committee on Herbal Medicinal Products be established at the EMEA. The provisions in the Directive on Medicinal Products that concern the Committee for Medicinal Products for Human Use shall apply by analogy to the Herbal Medicinal Products Committee (HMPC). The most important mission defined for the Herbal Medicinal Products Committee is to compile a list of herbal substances and preparations that may be included in traditional herbal medicinal products. For each substance/preparation, the list shall contain information on indication, strength, posology and method of administration.
The Committee shall also prepare common EU monographs for both herbal medicinal products and traditional herbal medicinal products.
MRP and DCP for traditional herbal medicinal products
The Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP) may be used for the traditional herbal medicinal products appearing on the list or in the monographs. The Committee on Herbal Medicinal Products shall settle all issues up for arbitration.
Directives concerning herbal medicinal products
The directives concerning herbal medicinal products are:
- Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use
- Commission Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. This directive defines “herbal medicinal products”.
- Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency