Directive 2004/24/EC on traditional herbal medicinal products, has been fully transposed in almost all European member states since 2007. This legislation introduced a new pathway for marketing and licensing traditional herbal medicines. Under this regulation a company is required to show the quality, safety and efficacy of their herbal medicinal products by demonstrating traditional use within the EU for at least 15 years and at least 30 years outside the EU. In addition, the herbal medicines must be now manufactured under GMP conditions.
Following a public consultation on proposals to end the ‘sell through’ of unlicensed herbal remedies legally on the market in April 2011, the MHRA has decided that with effect from 1 May 2014, all herbal medicinal products sold in the UK that fall under Directive 2004/24/EC require either a full marketing authorisation (MA) or a traditional herbal registration (THR) in order to remain on the market.
The herbal medicines can be approved for marketing either through a Traditional Herbal Registration (THR) or a Marketing Authorisation registration (MA).
SEQ can help clients to register their herbal medicinal products in the UK, Ireland or other EU countries, by providing regulatory support including:
Construction of the Module 1, including writing of the SPC, product labelling and Patient Information Leaflet (PIL) texts
Performance of Readability User Testing
Generation of Braille
Construction and writing of CTD Modules 2, 3, 4 and 5
Wholesalers Authorisation – preparation, compilation, submission and project management
Manufacturer and Importer Authorisations – preparation, compilation, submission.