SmPC: summary of product characteristics

Article 8(3)(j) of Directive 2001/83/EC requires every marketing authorisation application to include a summary of product characteristics, and Article 11 lists its contents in order: the name, strength and pharmaceutical form; qualitative and quantitative composition; clinical particulars including therapeutic indications, posology, contraindications, warnings, interactions, use in pregnancy and lactation, effects on driving, undesirable effects and overdose; pharmacological properties; pharmaceutical particulars such as excipients, shelf life and storage; the marketing authorisation holder and number; and the dates of first authorisation and of the last revision. Article 21 requires the authority to make the approved SmPC public. The Commission's guideline on the summary of product characteristics explains how each section should be written, and the QRD template fixes the layout.

The SmPC is the legal basis for the package leaflet, which must be drawn up in accordance with it, and for every promotional claim, which must be consistent with it. It is also the document that changes most often during a product's life: new indications, posology changes and safety updates are all Type II or Type IB variations to the SmPC, and the outcome of a PSUSA or a referral usually arrives as mandatory SmPC wording with a deadline to implement. For generics, Article 11 allows parts of the SmPC that refer to indications or pharmaceutical forms still protected by patent in a Member State to be omitted, which is the basis for the so-called carve-out.

What goes wrong: national SmPCs of the same product drift apart after years of variations that were approved in some markets and not others, until an Article 30 referral harmonises them; the leaflet is not updated when section 4.4 or 4.8 changes, so the two documents conflict; translations introduce clinical differences, for example in a posology table; generic SmPCs lag behind the reference product after a safety variation, which the Member States then chase; and section 10, the date of revision, is not updated, so nobody can tell which version a pack follows. Most of these faults surface during inspections or at the next variation, when the whole document has to be reconciled before anything new can be approved.