Summary of product characteristics (SmPC) contents and template
A summary of product characteristics (SmPC) gives approved information for healthcare professionals. Find its sections, QRD templates and official sources.
Summary of product characteristics (SmPC)
A summary of product characteristics (SmPC, or SPC in the UK) is the approved document that tells healthcare professionals how to use a medicine safely and effectively (SmPC guideline). For an EU SmPC, Article 11 of Directive 2001/83/EC sets the contents and the section order.
SmPC meaning, legal role and the SmPC guideline
The European Commission's SmPC guideline (Revision 2, September 2009, applies from 1 May 2010) says the SmPC is "the basis of information for healthcare professionals on how to use the medicinal product safely and effectively." The text sets out the position agreed during assessment, and it "cannot be changed except with the approval of the originating competent authority." It "forms an intrinsic and integral part of the marketing authorisation." General advice on treating a condition does not belong in it.
Every marketing authorisation application must include an SmPC under Article 8(3)(j) of Directive 2001/83/EC, with the packaging mock-ups and the package leaflet. The leaflet is for patients and must follow the SmPC (Article 59(1)). If the labelling or the leaflet doesn't match the SmPC particulars, Article 61(2) tells the authority to refuse the authorisation. The SmPC guideline says the Commission and certain Member States require a separate SmPC for each pharmaceutical form and strength. A new EU pharmaceutical directive to replace Directive 2001/83/EC has been politically agreed but not yet adopted, so Directive 2001/83/EC still applies.
What an SmPC contains
Article 11 lists the sections in a fixed order. The table uses the headings in the QRD annotated template v10.4. A few of those headings differ from the Directive. The template says "Fertility, pregnancy and lactation", "Contraindications" and "Incompatibilities". The Directive says "use during pregnancy and lactation", "contra-indications" and "major incompatibilities". Draft from the template.
| Section | Heading and subsections |
|---|---|
| 1 | Name of the medicinal product |
| 2 | Qualitative and quantitative composition |
| 3 | Pharmaceutical form |
| 4 | Clinical particulars: 4.1 Therapeutic indications; 4.2 Posology and method of administration; 4.3 Contraindications; 4.4 Special warnings and precautions for use; 4.5 Interaction with other medicinal products and other forms of interaction; 4.6 Fertility, pregnancy and lactation; 4.7 Effects on ability to drive and use machines; 4.8 Undesirable effects; 4.9 Overdose |
| 5 | Pharmacological properties: 5.1 Pharmacodynamic properties; 5.2 Pharmacokinetic properties; 5.3 Preclinical safety data |
| 6 | Pharmaceutical particulars: 6.1 List of excipients; 6.2 Incompatibilities; 6.3 Shelf life; 6.4 Special precautions for storage; 6.5 Nature and contents of container; 6.6 Special precautions for disposal (and other handling) |
| 7 | Marketing authorisation holder |
| 8 | Marketing authorisation number(s) |
| 9 | Date of first authorisation/renewal of the authorisation |
| 10 | Date of revision of the text |
| 11-12 | Dosimetry; instructions for preparation of radiopharmaceuticals (radiopharmaceuticals only) |
The SmPC guideline adds drafting rules on top of that list. Section 4.2 always needs a paediatric population subsection. Section 4.4 carries the risk-minimisation measures from the Risk Management Plan, and section 6.3 shelf lives must rest on stability data.
Article 11 also covers monitoring statements and generics. A medicine on the additional-monitoring list must include the black symbol and the sentence "This medicinal product is subject to additional monitoring". The QRD template places that statement before section 1. Every SmPC includes standard text asking healthcare professionals to report suspected adverse reactions through the national spontaneous reporting system. And for a generic authorised under Article 10, the SmPC may omit indications or dosage forms of the reference product that patent law still covered when the generic was marketed.
The QRD template (SmPC template)
EMA's Quality Review of Documents (QRD) template is the SmPC template. It also covers Annex II (conditions of the authorisation and batch release) and Annex III (labelling and the package leaflet). The EMA templates page lists the versions in use:
- centralised procedure: QRD template version 10.4, last updated 29 February 2024, in all EU languages plus Icelandic and Norwegian
- mutual recognition, decentralised and referral procedures, and PSUSA for nationally authorised products: version 4.2, also updated 29 February 2024
- ATMPs containing genetically modified cells: a separate template, version 1.1
Version 10.4 is for the centralised procedure only. The readability guideline says submissions to national authorities or EMA must follow the QRD format and use the electronic templates. A draft version 11 was consulted from 14 April to 31 August 2025, mainly to shorten the package leaflet. It hasn't been adopted.
Where to find the SmPC for a medicine
For a centrally authorised medicine, open its EPAR page on the EMA site and download the "Product information" document. The SmPC is Annex I. Mounjaro and Humira are two examples.
For a nationally authorised medicine, including MRP and DCP products, use the national regulator's register. Articles 21(3) and 106 require each Member State to publish the SmPC and to run a national medicines web-portal. In the UK, MHRA Products publishes SPCs, patient information leaflets and public assessment reports for UK-licensed medicines.
SPC in the UK
UK content rules sit in Schedule 8 of the Human Medicines Regulations 2012. The MHRA licensing guidance (updated 2 October 2026) asks for the SmPC on the SPC template and warns: "If this template is not used the submission will be rejected." Since 1 January 2025 the MHRA licenses medicines UK-wide, Northern Ireland included, under the Windsor Framework.
Is there a US SmPC?
The FDA does not use "SmPC". The nearest equivalent is the prescribing information for prescription drugs, in the Physician Labeling Rule format under 21 CFR 201.56 and 201.57. The FDA's PLR content and format guidance explains that layout.
RegAffairs AI answers these SmPC questions with links to the Directive and the guideline.