Guidance documents
EMA Pre-authorisation requirements
1/27/17
This is a useful start page for European pre-authorisation requirements. It includes a useful summary of product information requirements under point 3.1.8. It&…Read more.
The European Commission’s readability guideline
1/27/17
This is the core text for anybody drafting leaflets or needing to run usability testing in Europe. It is often known simply as the European guideline. Legally, it is more significa…Read more.
EMA guidance: template version 10, and risk management in lay language
1/17/16
The pan-European regulator publishes a number of guidelines on its requirements for written style, for timetables, and process. But the single most important document is probably t…Read more.
Useful start page for UK MHRA document requirements
10/22/15
Patient information is the subject of more regulatory guidance than any other area of the MHRA’s operations. This link takes you to the best start page on the MHRA’s we…Read more.