After many years and numerous amendments, the Traditional Herbal Medicinal Products Directive has been formally adopted by the European Union Council of Ministers. Its publication in the Official Journal of the European Community was due to occur as FF&N went to press, after which EU members have 18 months to implement it into their national legislatures.
A seven-year transitional period has been granted; herbal products that come under the jurisdiction of the directive will not be required to obtain appropriate registrations until 2011.
?This could lead to the introduction of a simplified registration scheme for manufactured over-the-counter traditional herbal remedies in the second half of 2005,? noted the UK-based Medicines and Healthcare products Regulatory Agency.
?There would then be a further ?transitional? period of five-and-a-half years to allow all existing herbal medicines to gain a Traditional Registration.?
Under the directive, herbal manufacturers will have to demonstrate that products have been safely used for 30 years in the EU, or for a combination of 15 years within the EU and 15 years outside it. Manufacturers will be required to register unlicensed products and produce them according to ?good manufacturing practices.?
Active ingredients will be rigorously tested for safety and proof of quality.
The directive will apply to the 10 countries that joined the EU on May 1.