Supporting existing and prospective MAHs.
As a leading provider of Pharmacovigilance and Regulatory Affairs services in the EEA and beyond, we can provide a comprehensive service solution for Marketing Authorization Holders who are already marketing medicinal products, or prospective MAHs, coming to the fast-growing cannabinoid derivative area.
We DO NOT support the development, manufacture or distribution of Cannabis and CBD products available over the counter.
Our support is strictly limited to regulated cannabinoid based medicinal products which are subject to the same obligations as other pharmaceutical products, including clinical trials.
Our experience with existing cannabinoid-based medicines, as well as with advanced therapies and biotech products, makes us ideally suited to provide expert guidance and support from clinical development and core risk management planning, through to all your registration, post-marketing, and life-cycle maintenance needs.
Arriello currently services multiple centrally approved cannabinoid-based medicinal products and can provide expert, tailored solutions in the following phases:
Country by country guidance for MAHs in Europe and the CIS regions.
The market for medicinal cannabis products is growing fast around the world and the UN commission have just reclassified these products in line with World Health Organization recommendations, yet despite the idea of a harmonized European market there are in fact multiple variations and requirements at the national level that can make it unclear… without the brand new Arriello guide!
Put together by Director of Drug Safety, Peter Kohut and MENA PV specialist Ibrahim Said Abdeldayem, the Arriello guide to marketing medicinal cannabis products in Europe illustrates the situation across this and the adjacent CIS region with details for each country and links to specific regulations.