Wednesday, May 04, 2011

EU Directive on Traditional Herbal Medicinal Products Goes into Full Force on May 1, 2011: Alternative Medicines to be Sold Must Be Registered for Safety and Efficacy

After a seven-year transition period which started in 2004, alternative, herbal, Ayurvedic, Chinese, African, etc. medicines must be registered in the European Union for safety and efficacy as of May 1, 2011, or they may not be sold as "medicines".

The EU Directive on Traditional Herbal Medicinal Products does not prohibit the sale of traditional herbs or plants but they can not be sold as "medicines" without registration, which requires proof of safety and efficacy.

The EUROPA Press Release of April 29, 2011 by the European Union provides as follows:
"Traditional herbal medicines: more safety for products put on EU market
From tomorrow, EU citizens can be reassured that the traditional herbal medicines they buy in the EU are safe and effective. The expiry of the 7 year transition period set out in the 2004 Herbal Directive (2004/24/EC) means that only medicinal products which have been registered or authorised can remain on the EU market after 1 May 2011. 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. At the same time, the Directive provides the necessary guarantees of their quality, safety and efficacy.
John Dalli, European Commissioner for Health and Consumer Policy, said, "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."
Simplified procedure
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. The simplified procedure introduced by the Herbal Directive allows these products to be registered without the safety tests and clinical trials that a full marketing authorisation procedure would involve.
Instead, 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.
Seven years to register
The Herbal Directive was adopted by the European Parliament and the Council on 31 March 2004. It gave an exceptionally long transition period of 7 years for manufacturers to register their traditional herbal products already on the EU market when the Directive entered into force.
Applicants have had 7 years to apply to the competent authority in the Member States(s) where they wanted to market their product. 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. After this date, producers of traditional herbal medicines can still apply for a registration through the simplified registration procedure.
The Herbals Directive:
  • Does not ban traditional medicines from the European market. On the contrary, it introduces a lighter, simpler and less costly registration procedure than for other medicinal products. Plus it has given producers of traditional herbal medicinal products an exceptionally long transition period of 7 years to register their products.
  • Does not ban vitamins, mineral supplements and herbal teas.
  • Does not ban alternative therapies and therapists, homeopathy, plants or books on plants.
Background
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 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.
The Herbals Directive updated the 2001 Directive on the Community code for medicinal products for human use (Directive 2001/83/EC) by introducing a simplified procedure specifically for traditional herbal medicinal products.
Link to MEMO/11/71
Further information:
"

Hat tip to EUobserver.

Our Websites and Blogs

3D Printing and More 99 is not 100 Aabecis AK Photo Blog Ancient Egypt Weblog Ancient Signs (the book) Ancient World Blog AndisKaulins.com Anthropomorphic Design Archaeology Travel Photos (blog) Archaeology Travel Photos (Flickr) Archaeo Pundit Arts Pundit Astrology and Birth Baltic Coachman Bible Pundit Biotechnology Pundit Book Pundit Chronology of the Ancient World Computer Pundit DVD Pundit Easter Island Script Echolat edu.edu Einstein’s Voice Energy Environment and Climate Blog Etruscan Bronze Liver of Piacenza EU Laws EU Legal EU Pundit FaceBook Pundit Gadget Pundit Garden Pundit Golf Pundit Google Pundit Gourmet Pundit Hand Proof HousePundit Human Migrations Idea Pundit Illyrian Language Indus Valley Script Infinity One : The Secret of the First Disk (the game) Jostandis Journal Pundit Kaulins Genealogy Blog Kaulinsium Kiel & Kieler Latvian Blog LawPundit.com Law Pundit Blog LexiLine.com LexiLine Group Lexiline Journal Library Pundit Lingwhizt LinkedIn Literary Pundit Magnifichess Make it Music Maps and Cartography Megalithic World Megaliths Blog Megaliths.net Minoan Culture Mutatis Mutandis Nanotech Pundit Nostratic Languages Official Pundit Phaistos Disc Pharaonic Hieroglyphs Photo Blog of the World Pinterest Prehistoric Art Pundit Private Wealth Blog PunditMania Quanticalian Quick to Travel Quill Pundit Road Pundit Shelfari Sky Earth Drones Sky Earth Native America SlideShare (akaulins) Sport Pundit Star Pundit Stars Stones and Scholars (blog) Stars Stones and Scholars (book) Stonehenge Pundit The Enchanted Glass Twitter Pundit UbiquitousPundit Vision of Change VoicePundit WatchPundit Wearable Technology Wizard WeTechWi Wine Pundit Word Pundit xistmz YahooPundit zistmz