EMA: Q&A for Cannabis-Derived Medicinal Products
The EMA has published a question and answer document on the regulatory requirements for the authorisation of Cannabis-derived medicinal products in the EU and the work of the Committee for Herbal Medicinal Products (HMPC) in relation to medicinal plant monographs. This was considered useful as those involved in the production of Cannabis products often have little experience of the EU regulatory system for medicinal products.
The 9 answers explain, among other things, that there is no specific legal framework for Cannabis-derived medicinal products, but that EU pharmaceutical legislation applies and that a marketing authorisation is a prerequisite for placing a medicinal product on the market. It also explains that there are only exemptions for traditional herbal medicinal products in the EU and what is meant by an EU monograph for herbal substances and preparations.
Source:
EMA: Q&A Document
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
