Herbal medicinal products in the European Union - AESGP

Summary
The quality of imported medicinal plants and their preparations is assessed
differently in the various Member States. Finished products are often treated as
New Chemical Entities (NCEs) requiring full proof of quality, safety and efficacy.
In several countries there are however no specific regulations on the control o f
raw materials or crude drugs. This is particularly the case for products entering the
market as foodstuffs or other products not controlled in the same way as herbal
medicinal products.
VII.3.5 Important Products
The number of herbal medicinal products authorised in each country together with their
major ingredients and indications are listed below insofar as the information is available.
Austria
Approximately 700 herbal medicinal products have been officially approved, around 400 of
which according to the normal registration procedure (Section 13 of the Medicines Law) and
approximately 300 under an abbreviated procedure (Section 17a). Herbal medicinal products
are usually combinations of herbal drugs, although some combinations with allopathic
chemical ingredients exist (e.g., “old approvals” without a modern marketing
authorisation). In addition, there are approximately six hundred homeopathics with herbal
ingredients approved or registered. In principle, any indication may be applied for if it is
supported by studies or bibliographic data. Lists of major ingredients are not available.
Belgium
Some herbal medicinal products sold on the market were notified in 1964. The validation
process for these products was supposed to be completed in 1990. However, for many of the
herbal medicinal products that are sold in traditional forms (e.g., herbal teas), the
validation process continues.
Apart from these products, a small number of herbal medicinal products (approximately 20)
are marketed according to the procedure implemented in 1995. Other registration
applications are pending. The indications accepted in the registration of these herbal
medicinal products are strictly scrutinised by the Ministry of Public Health.
Denmark
By 12 June 1998, 159 natural medicinal products were authorised [DK 4]. The list is not
exclusively made up of natural remedies with an active herbal ingredient.
Finland
There are 131 herbal medicinal products with a valid marketing authorisation.
Additionally, 140 anthroposophic products (with the indication: “to be used as anthroposophic
product”) and one homeopathic product (with the indication: “to be used as homeopathic
product”) have been approved as herbal medicinal products. Herbal medicinal products
contain more than 1/10 000 of the anthroposophic/homeopathic parent solution, so they cannot
be accepted in the registration procedure for anthroposophic/homeopathic products.
Below are lists of the main indications for and the main ingredients used in herbal
medicinal products in Finland.
• Mild symptoms due to common cold, headache, temporary cough
• Maintenance of vitamin A and vitamin D levels
• Mild stimulating effect on blood circulation in limbs
• Food additive containing ubidecarenone
• Favourable effect on the function of the bladder
73