The European regulatory framework for medicinal products covers authorized 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 labeling and packaging requirements that cannabis-containing medicinal products need to comply with when their placing on the European market is authorized.
This regulatory report will provide you with:
- A clear and detailed understanding of current regulatory requirements affecting this sector in a specific jurisdiction, enables you to be confident your business and your products are compliant.
- The ability to plan ahead for specific regulatory changes.
- Strategic understanding of the jurisdiction's policy climate enables 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 authorization holders
Methodology
General Methodology/Sources
- Consumer and market participant (manufacturer/brand) surveys.
- Consolidation of publicly available information.
- Legal tracking through legal database checking and sourcing information from government regulators and other law-making bodies.
- Pricing and product information from online and offline retail data gathering, including local fieldwork teams.
- Findings from key industry events and interviews with leading market players and opinion leaders.
- Partnerships with leading research agencies.
- Quantitative and qualitative research and client collaborations.
- Cross-referenced data between markets.
- Tamarind Media proprietary market model.
Please note that each report has its own methodology, so you should always refer to the methodology applied in the report you purchase.
LOADING...
