Q.01

What is a summary of product characteristics?

In EU medicines law, the summary of product characteristics (SmPC) is the approved document that sets out the authorised information about a medicinal product for human use. Article 11 of Directive 2001/83/EC lists what it must contain and the order of sections, and the competent authority approves its wording when it grants the marketing authorisation [1][2]. The patient package leaflet must be drawn up in line with it [3].

Approach: I read the current consolidated text of Directive 2001/83/EC and the European Commission's SmPC guideline in EudraLex Volume 2 (Notice to Applicants). This covers the EU definition only. I did not research equivalents in other jurisdictions, such as the US prescribing information.

What Article 11 requires, in this order [1]

SectionContent
1Name of the medicinal product, then strength and pharmaceutical form
2Qualitative and quantitative composition (active substances and excipients that matter for proper use)
3Pharmaceutical form
4Clinical particulars: 4.1 indications; 4.2 posology and method of administration; 4.3 contraindications; 4.4 special warnings and precautions; 4.5 interactions; 4.6 pregnancy and lactation; 4.7 effects on driving and using machines; 4.8 undesirable effects; 4.9 overdose
5Pharmacological properties: 5.1 pharmacodynamics; 5.2 pharmacokinetics; 5.3 preclinical safety data
6Pharmaceutical particulars: 6.1 excipients; 6.2 incompatibilities; 6.3 shelf life; 6.4 storage; 6.5 container; 6.6 disposal
7–10Marketing authorisation holder; authorisation number(s); date of first authorisation or renewal; date the text was revised
11–12For radiopharmaceuticals only: internal radiation dosimetry, and instructions for extemporaneous preparation and quality control

Article 11 also requires:

  • Additional monitoring: products on the additional-monitoring list under Article 23 of Regulation (EC) No 726/2004 must carry the black symbol and the statement "This medicinal product is subject to additional monitoring".
  • Adverse reaction reporting: every SmPC must include standard text asking healthcare professionals to report suspected adverse reactions through the national spontaneous reporting system.
  • Generics: for generic applications under Article 10, parts of the reference product's SmPC on indications or dosage forms still covered by patent law at the time the generic was marketed need not be included.

[1]

Its legal role

  • Approval: when the authorisation is issued, the competent authority informs the holder of the approved SmPC. It must make sure the information stays in line with what was accepted at authorisation or later [2].
  • Publication: national competent authorities must publish the SmPC, together with the marketing authorisation and the package leaflet [2].
  • Link to the leaflet: the package leaflet is the patient-facing document and must follow the SmPC (Article 59(1)) [3].

How the sections are written in practice

The Commission's SmPC guideline sets out section-by-section drafting rules for applicants and holders. Some examples:

  • Section 4.2: must always include a "paediatric population" sub-section, with standard statements where the product has no paediatric indication [4].
  • Section 4.4: should cover risk-minimisation measures requested in the Risk Management Plan [5].
  • Section 4.6: should give the reasons behind recommendations for use in pregnancy and breastfeeding [6].
  • Section 6.3: stated shelf lives, including in-use and temporary storage periods, must be based on stability data [7].
Q.02

Is there a template for writing one?

Yes. In the EU you don't write an SmPC from a blank page. You use the QRD (Quality Review of Documents) product-information template, which Member States and EMA agreed. It lays out the SmPC, labelling and package leaflet in the required order, with the standard headings and statements. An "Annotated QRD Template" gives detailed guidance on how to fill in each section [8].

Approach: I searched the European Commission's guidance in EudraLex Volume 2 (Notice to Applicants), including the SmPC guideline and the readability guideline. I then opened EMA's product-information templates page to see which versions are current.

What the guidance says

  • When you submit to national competent authorities or EMA, the product-information text must follow the "QRD convention" format and layout and use the electronic product-information templates. The templates are available in all EEA languages [8].
  • When you use the templates, you should also follow the relevant Community guidelines (such as the SmPC guideline), the QRD guidance and the Annotated QRD Template. EMA and the Heads of Medicines Agencies (HMA) both publish the annotated template [8].
  • The SmPC guideline is written to line up with the QRD template. Where a heading differs, it points to the template wording; for example, section 6.6 is "Special precautions for disposal " in the QRD template [9].
  • Following the QRD templates does not remove the duty to user-test the package leaflet (or consult patients in another way) [8].

Which version to use, according to EMA's product-information templates page:

ProcedureTemplate
Centralised (EMA)QRD template version 10.4, in 26 languages. The English annotated template was last updated 29/02/2024.
Mutual recognition, decentralised, referrals and PSUSA (nationally authorised products only)Template version 4.2. The page points to the CMDh annotated QRD template for these procedures.
ATMPs containing genetically modified cellsA separate template, version 1.1

Pending change: a draft QRD template version 11 went out for public consultation from 14/04/2025 to 31/08/2025. It mainly aims to make the package leaflet shorter and more patient-friendly through new standard statements. The EMA page did not show an adoption date for version 11, so version 10.4 is the one currently listed for centralised products.

The templates are Word files on the EMA (and CMDh/HMA) sites; the datasets I searched don't hold the files themselves. I can go through the annotated template's instructions for a particular SmPC section if that helps.

Q.03

Where can I find the SmPC for a medicine?

Where you find an SmPC depends on how the medicine was authorised. For a medicine authorised through the EU centralised procedure, use its EPAR page on the EMA website. For a medicine authorised nationally (including through mutual recognition or the decentralised procedure), use the national competent authority's medicines web-portal. EU law requires those authorities to publish SmPCs [2][10].

Approach: I read Directive 2001/83/EC and Regulation (EC) No 726/2004, then checked EMA's register of centrally authorised medicines and the Danish Medicines Agency's register of approved medicines, using Humira as the example. This covers the EU only. I did not look at other jurisdictions such as the US (FDA prescribing information) or the UK.

1. Centrally authorised medicines: EMA

  • EMA's register gives each medicine a link to its EPAR page. For Humira (EMEA/H/C/000481) the link is https://www.ema.europa.eu/en/medicines/human/EPAR/humira. The SmPC is part of the product information on that page [11].

  • To see whether the text is recent, the register shows:

    • the latest procedure that changed the product information (for Humira, EMA/VR/0000287800);
    • the revision number (99);
    • the date the record was last updated (14/10/2026).

    [11]

  • The register's "Therapeutic indication" field may just say "Please refer to the product information document", so for the approved wording you need the SmPC itself [11].

  • If the medicine is under additional monitoring, the EMA list of those medicines must link to its product information [12].

2. Nationally authorised medicines: the national authority

  • Article 21(3) of the Directive requires national competent authorities to publish, without delay, the marketing authorisation, package leaflet and SmPC for each medicine they have authorised [2].
  • Article 106(b) requires each Member State to run a national medicines web-portal that publishes SmPCs and package leaflets, linked to the European medicines web-portal [10].
  • National registers also list centrally authorised products. Denmark's register, for example, shows Humira with the procedure "Central" [13]. For those products, EMA's EPAR page is still where the English reference text is held.

Practical tip: if you don't know the route, search EMA's register first. If the medicine isn't there, it was authorised nationally, so go to the authority of the Member State where it is marketed.

I can look up a specific medicine in EMA's register or the Danish register and give you its EPAR link and latest product-information procedure.

Q.04