SmPC and PIL (Summary of Product Characteristics and Patient Information Leaflet)
The SmPC is the official, regulator-approved description of a licensed medicine and the conditions of its use, written for healthcare professionals; the PIL is the leaflet in the pack, based on the SmPC and written for patients.
Full definition
When a medicine is licensed in the UK, it comes with two key documents. The Summary of Product Characteristics (SmPC, sometimes written SPC) is, in the MHRA's words, "a description of a medicinal product's properties and the conditions attached to its use". It tells doctors, nurses and pharmacists how to prescribe and use the medicine: what it is licensed for, the dose, who should not take it, warnings, side effects, and how the body handles it. The Patient Information Leaflet (PIL) is the leaflet in every medicine pack, written for patients and based on the information in the SmPC. The eMC, the UK's main online library of this information, explains that the pharmaceutical company drafts these documents and the MHRA (or, historically, the European Medicines Agency) checks and approves them, and that an SmPC follows a standard numbered format. That format is useful once you know it: section 4.1 is what the medicine is licensed for, 4.4 is special warnings, 4.8 is side effects and 5.2 covers how the body absorbs and clears the drug, including its half-life. The documents are updated when new safety information emerges. For example, the MHRA's Drug Safety Update of 11 May 2026 announced updates to the finasteride 1 mg SmPC and PIL, and a precautionary mood warning for dutasteride; see our MHRA safety updates page. You can read the SmPC and PIL for UK medicines free on the eMC (medicines.org.uk) or the MHRA's products website. Our product pages, such as finasteride 1 mg, link to the relevant SmPC. When a medicine is prescribed off-label, the leaflet may describe a different condition or dose from yours, and the MHRA highlights this as a known source of confusion.
What it does not mean
An SmPC is not marketing material and it is not a personal prescription: it describes the medicine in general, and your prescriber decides how it applies to you. Its absence also tells you something. A compounded unlicensed special has no UK marketing authorisation, so it has no SmPC of its own, and the MHRA notes that some unlicensed medicines come with little or no product information. A US label or "FDA approval" is not a substitute for a UK SmPC.
Examples in use
Honest use
"The Propecia SmPC (section 4.2) says three to six months of once-daily treatment are generally needed before evidence of stabilisation of hair loss can be expected."
Common misuse
"Clinically proven formula, see our product information." (Pointing to a brand's own product sheet as though it were an MHRA-approved SmPC, for a product that has no UK licence.)
UK regulatory source
MHRA, Find product information about medicines (GOV.UK); eMC (Datapharm), About the eMC; MHRA Drug Safety Update, Off-label or unlicensed use of medicines: prescribers' responsibilities; MHRA Drug Safety Update, 11 May 2026