Only medicinal products which have been registered or authorised can remain on the EU market after 1 May 2011. From that date, the Herbal Directive will have completed the seven year transition period.

On the 1 of May, the Directive (2004/24/EC) will complete the transition period. It means that only medicinal products which have been registered or authorised can remain on the EU market. The Herbal Directive introduces a simpler registration procedure than for other medicinal products, in respect of the long history of use of traditional herbal medicinal products. Besides it provides the necessary guarantees of their quality, safety and efficacy.

The simplified procedure introduced allows these products to be registered without the safety tests and clinical trials that a full marketing authorisation procedure would involve. Nevertheless, an applicant who wishes to register a traditional herbal medicinal product must provide documentation showing that the product in question is not harmful in the specified conditions of use. They must also provide evidence that the product has a proven track record, i.e. that it has been used safely for at least 30 years with 15 of these in the EU.

Medicinal products that are made from these substances are known as "Herbal Medicinal Products". Even though they are natural, a number of these products may be harmful to health. Therefore, these products are covered by pharmaceutical legislation, which aims to protect public health by ensuring the safety, efficacy and quality of medicinal products. However, this Directive does not ban vitamins, mineral supplements and herbal teas and it does not ban alternative therapies and therapists, homeopathy, plants or books on plants.