Brussels, April 29 (EuAsiaNews): The 7-year transition period set out in the 2004 Herbal legislation of the European Union expires on Saturday which means that only medicinal products which have been registered or authorised can remain on the EU market after 1 May 2011.
In order to protect public health, all medicinal products, including traditional herbal medicinal products, need a marketing authorisation to be placed on the EU market, said a statement by the European Commission Friday.
If, by 30 April 2011, a herbal medicinal product is not registered or authorised, then it may not be on the EU market after 1 May 2011, said the EU’s executive body.
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, ie. that it has been used safely for at least 30 years �€\” 15 of these in the EU.
The statement clarifi!ed that some plants contain substances that may be used to treat diseases. 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 the EU pharmaceutical legislation, which aims to protect public health by ensuring the safety, efficacy and quality of medicinal products.
\”Traditional\” herbal medicinal products are a sub group of herbal medicinal products that have been in use for at least 30 years, including at least 15 years in the EU, and that are intended to be used without the supervision of a medical practitioner and are not administered by injection.
This category is not limited to European traditional herbal medicinal products; it can also include Chinese and Ayurdevic medicinal products, noted the EU statement.
John Dalli, European Commissioner for Health and Consumer Policy, said in press statement that , \”We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficacy. \”
\”Patients can now be confident about the traditional herbal medicinal products they buy in the EU, \” he said.
The statement clarified that the Herbal legislation \”does not ban traditional medicines from the European market. It does not ban vitamins, mineral supplements and herbal teas. It does not ban alternative therapies and therapists, homeopathy, plants or books on plants.\”