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Description
The European regulatory framework for medicinal products covers authorised cannabis-containing pharmaceutical products. The latter are subject to the general requirements applicable to medicinal products, meaning that the European Union does not have a specific framework for cannabis-derived medicinal products
This report seeks to outline the labelling and packaging requirements that cannabis-containing medicinal products need to comply with when their placing on the European market is authorised.
Reasons to buy
A CannIntelligence regulatory report will provide you with:
- A clear and detailed understanding of current regulatory requirements affecting this sector in a specific jurisdiction, enabling you to be confident your business and your products are compliant.
- The ability to plan ahead for specific regulatory changes.
- Strategic understanding of the policy climate within the jurisdiction, enabling you to forecast how it might affect business development.
- Sources of further information, for example, links to full texts of legislation and contact details for relevant government offices.
Table of contents
- Executive summary
- Introduction
- Overview of the authorisation procedure
- Common labelling requirements
- Outer packaging
- Immediate packaging
- Package leaflet
- Labelling requirements for medicinal products in the UK
- Labelling guidelines for marketing authorisation holders
Methodology
Our research is completely independent and original. It is conducted by CannIntelligence’s multilingual legal analysis team, all specialists in this sector, and goes through a rigorous review and editing process before publication. Research draws on multiple sources, including: online and offline resources and data, specialist legal software, our own extensive databases and report archives, interviews with key stakeholders and government officials, and collaboration with local legal firms and on-the-ground professionals in the jurisdictions covered.
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