Over the past few months, the European Medicines Agency (EMA) has issued a series of guidance documents to reach a point of harmonisation when it comes to terminology, quality and specification of herbal medicinal products. These guidelines serve as a broad-based understanding to guide the transparency of the industry towards a point where everybody speaks the same language.
It’s a young business and roles aren’t that defined yet, so it is only natural that there will be a discrepancy between what some people mean and what some people hear. Your cannabis may be my dagga, or your marijuana may be someone else’s bubatz.
Guidelines on terminology, quality and specification of herbal medicinal products
Requested by the European Commission, the EMA, reflecting the growing interest in cannabis-based medicine, has compiled a defined glossary of terminology to be used when making certain claims to products. They have followed this up with a guideline to quality and specifications to herbal medicinal products. This includes a written GACP confirmation for the herbal substance.
This attempt is a solid step towards standardising the industry in Europe where language, cultural differences and the way in which business is done varies from country to country. Most importantly it will try to create a uniform set of rules in order to level the playing field. Making rules and sticking to them increases the transparency of the business and ups the legitimacy of how it works. The glossary summarises existing scientific and legislative terminology taking into account EU legislation, EU pharmaceutical quality guidelines and European Pharmacopoeia standards.
Here you can find all the details you need:
- Guideline on quality of herbal medicinal products/traditional herbal medicinal products
- Concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin
- Breakdown of new terminology defined by the EMA
- Press release ‘EMA Publishes Final Guidelines on Quality and Specifications for HMPs’
Do you have any questions about the guidelines or need help implementing them? Contact us, we are happy to help.