CRED SMPC 2024

17/09/2024

MHRA SmPC Template

How

Link to SmPC template: SPC_template.docx (live.com)

Link to SPC fragments: Medicines: apply for a variation to your marketing authorisation - GOV.UK (www.gov.uk)

The Organisation for Professionals in Regulatory Affairs

23

So how do you fill the boxes?

How

Internal Sources: •

•

Company Core Data Sheet

• The data (clinical, non-clinical, CMC, etc.)

External Sources: • Guidelines • Labelling precedent – other medicines in the same class or for the same indication • Class labelling • EMA training slides • QRD associated appendices • QRD reference documents • EDQM Standard Terms website

•

The Organisation for Professionals in Regulatory Affairs

24