Traditional Herbal Medicinal Products THMP
Pharma Experts has received a number of calls from potential clients based in the UK and India with an interest in the process involved in the marketing and distribution of Traditional Herbal Medicinal Products THMP including Ayurvedic medicines.
The European Commission Report Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products ( THMP ) mentions Ayurvedic medicines as a non-European medicine systems in which herbal medicinal products are traditionally use.
Under Directive 2001/83/EC the legislation establishes specific requirements for THMP with regards to their placement on the market however it does not regulate the practice of traditional medicine.
To market a THMP (herbal medicines) in the UK an application for registration needs to be made to the MHRA. The application requires the submission of a number of documents with including:
- • A technical dossier covering the quality of the herbal ingredients
- • A safety review by an expert (e.g. doctor, pharmacist, practitioner etc)
- • Summary of product characteristics
- • Patient information leaflet and labelling
We recommend the applicant checks the banned or restricted list of herbal ingredients is first checked.
The supply and distribution of THMP is regulated by the MHRA and therefore wholesale distributors of human medicines will need to ensure that they are licensed to do so.
Good Distribution Practice GDP and THMP
Current holders of Wholesale Distribution Authorisations who wish to distribute this category of medicines should check it is clearly listed on their licence. If not, a variation needs to be submitted to the MHRA.
It should be noted that herbal practitioners are not required to hold a licence for the supply of herbal medicines created on their premises for the supply to patients following one to one consultation.
For clients new to the Wholesale Distribution of human medicines we recommend they attend one of our training events on Good Distribution Practice which will give them a comprehensive insight into the regulations.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.