Herbal product manufacturers having available the services of a Qualified Person, a resident of an EU member state, need to apply to the Medicines and Healthcare Products Regulatory Agency (MHRA) for the grant of a traditional herbal registration for every product and each must comply with the official published standards. The application should include

1. Statement indicating whether the herbal medicinal product is one that should be available only from a pharmacy or should be on general sale.
2. Product medicinal indications must be as per the listing in the annexures to the EMEA Guidelines.
3. Safety data put together as a bibliographic review along with an expert report on both non-clinical and clinical aspects of safety. As per EMEA the expert can be a registered doctor, registered pharmacist or other scientifically qualified individual with relevant competence, for example, a toxicologist or an herbal practitioner who is a member of a professional body that is working towards the statutory regulation of the herbal medicine profession, or a registered herbal practitioner.
4. As covered in the ‘Key Requirements’ section, the application will need to be accompanied by bibliographic or expert evidence that the medicinal product or a corresponding product has been in medicinal use throughout a period of 30 years. The new European Committee, the Committee on Herbal Medicinal Products (HMPC) will establish the ‘European positive list’ provided for in Directive 2004/24/EC.
5. Product quality should be supported with a technical dossier covering quality of herbal ingredients and the finished product including details of all necessary physicochemical, biological and microbiological tests, covering residual solvents, pesticide residues, microbial limits and heavy metal residues.
6. Finished product specifications should include summary of stability studies undertaken (conditions, batches, analytical procedures) results and conclusions, the proposed storage condition and shelf life.
7. The labelling and patient information as per requirements of MHRA Guidance Note 25 should include name of the product, strength, pharmaceutical form, quantity of active ingredients posology, method of administration, indications, contraindications, excipients, shelf life and any special warnings and precautions for use and a summary of product characteristics.

An independent body concerned with the advancement of the status of phytomedicine in Europe is the European Scientific Cooperative of Phytotherapy (ESCOP). It is an umbrella organization representing national herbal medicine phytotherapy associations across Europe. Among its other activities ESCOP endeavours to assist with the harmonization of the regulatory status of phytomedicines at the European level. In particular it provides state-of the-art reviews of the therapeutic use of leading herbal medicinal products based on leading expertise across Europe. From 1997 to 2010, it has published 108 monographs and has coordinated and completed EU BIOMED research programme determining European standards for the safe and effective use of phytomedicines.