On 21 January 2013 the European Medicines Agency (EMA) published on its website a guidance document for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.
EMA’s guidance (as highlighted in their press release below) consists of a set of presentations detailing the information that should be included in each of the sections of the SmPC, together with background information on SmPCs both as a presentation and a video. EMA also makes available two videos explaining how to complete the SmPC sections on the therapeutic indication and pharmacodynamic properties of a medicine, and on undesirable effects.
The guidance kit into account the principles contained in the European Commission’s guideline on SmPC. The purpose of the document is to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the Agency as part of applications for new marketing authorisations or updates to existing marketing authorisations.
The guidance kit includes the following presentations:
1. What is the summary of product characteristics (SmPC)?
2. Where can SmPC information be found?
3. Which information can be found in the SmPC?
4. Structure of the information within the SmPC
5. Essential information for the use of the medicine
6. Information on the benefits of the medicine
7. Information on the risks of the medicine
8. Information for individualised care
9. Pharmaceutical information
10. How is the information in the SmPC prepared?
11. What is not included in the SmPC?
12. How can you help maintain the best quality of information?
13. Test your knowledge on the SmPC
14. Where to find more information?
For further information