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TL;DRSmPC stands for Summary of Product Characteristics, the legally approved product information that a competent authority issues for a medicine and that is addressed to healthcare professionals. In Germany it is called the Fachinformation. Its content and its order are prescribed by Article 11 of Directive 2001/83/EC.
The SmPC is not marketing material and it is not a patient document. It is the reference text a competent authority approves when it grants a marketing authorisation, and it defines what may be said about a medicine at all: the indications, the posology, the contraindications, the known risks. Company communication about the product has to stay inside it, and the package leaflet handed to the patient is derived from it rather than written independently.
Two layers apply in Germany at the same time, and they say the same thing from different directions.
At EU level, Article 11 of Directive 2001/83/EC on the Community code relating to medicinal products for human use sets out the content. The wording is prescriptive rather than advisory: the summary of the product characteristics "shall contain, in the order indicated below, the following information". The sequence of sections is therefore not an editorial convention, it is law.
At national level, § 11a AMG (Arzneimittelgesetz) obliges the pharmaceutical company to supply the Fachinformation on request, and it mirrors the same numbered structure. The addressees named in § 11a AMG are physicians, dentists, veterinarians and pharmacists. That provision is what makes the SmPC a Fachkreise document in German law: it is written for people who are qualified to weigh a contraindication, not for the person taking the tablet.
The authority that grants the marketing authorisation also approves the SmPC. Under Article 21 of the Directive, the holder is informed of the summary of the product characteristics "as approved by it", and the competent authorities have to make the authorisation together with the SmPC publicly available without delay.
Which authority that is depends on the route:
Article 11 fixes the order and the EMA QRD template gives the sections their working titles. For an ordinary medicine, ten numbered sections apply. Article 11 adds two further points, 11 and 12, but both concern radiopharmaceuticals only, which is why the SmPC is normally described as a ten section document.
| Section no. | Title (EMA QRD template) | What it contains |
|---|---|---|
| 1 | Name of the medicinal product | Product name followed by strength and pharmaceutical form. |
| 2 | Qualitative and quantitative composition | Active substances and those excipients whose knowledge is essential for proper administration, under the usual common name or chemical description. |
| 3 | Pharmaceutical form | Tablet, solution for injection, and so on, with appearance where relevant. |
| 4 | Clinical particulars | The clinical core, in nine subsections: 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 | Name and address of the holder. |
| 8 | Marketing authorisation number(s) | The authorisation number or numbers. |
| 9 | Date of first authorisation/renewal of the authorisation | Date of first authorisation and of the most recent renewal. |
| 10 | Date of revision of the text | The version stamp. This is the field that tells you whether the copy in front of you is current. |
Two details are worth knowing because they trip people up. First, the template and the Directive are not word for word identical: the QRD template titles section 4.6 "Fertility, pregnancy and lactation", while the Article 11 text speaks of "use during pregnancy and lactation". The template wording is what you will see in current documents. Second, for a medicine under additional monitoring, the inverted black equilateral triangle and its standard statement sit before section 1, not inside a numbered section.
This is the distinction that decides which document you should be quoting. They are not two versions of the same text written for different reading levels. One is derived from the other, and the direction is fixed by Article 59 of the Directive: "The package leaflet shall be drawn up in accordance with the summary of the product characteristics".
| SmPC (Fachinformation) | Package leaflet (Packungsbeilage, PIL) | |
|---|---|---|
| Audience | Healthcare professionals: physicians, dentists, veterinarians, pharmacists (§ 11a AMG) | The patient or the person administering the medicine |
| Legal status | The approved reference text; content and order fixed by Article 11 of Directive 2001/83/EC | Derived from the SmPC under Article 59; must not contradict it |
| Who approves it | The competent authority that grants the marketing authorisation (Article 21) | The same authority, as part of the same product information set |
| Language level | Technical, complete, quantified | Plain language, selective, aimed at safe use rather than completeness |
| Practical use | Prescribing, dispensing, clinical decisions, interaction and contraindication checks | Patient counselling and self-administration |
The practical consequence: if a leaflet and an SmPC appear to disagree, the SmPC is the document that governs. The leaflet is a simplification of it, and a simplification is allowed to omit but not to contradict.
An SmPC is never finished at approval. Article 23 of the Directive requires the authorisation holder to "forthwith supply to the competent authority any new information which might entail the amendment of the particulars or documents referred to in" Article 11, among others. New safety data therefore has to flow back into the text for as long as the product is on the market, and a five year old copy of an SmPC is not a slightly outdated document, it is potentially a wrong one.
A typical update runs like this:
The Rote-Hand-Brief is the part that is easy to miss operationally. It travels faster than the document it describes, so for a period the letter is current and the SmPC copy in your system is not.
In practice there are three routes, and they answer different questions. Under § 11a AMG you can request the Fachinformation from the pharmaceutical company directly, which is the route with the strongest legal standing but the slowest turnaround. Under Article 21(3) the competent authority publishes the SmPC alongside the authorisation, which works well for centrally authorised products. For day to day work across a whole product range, most professionals reach the document through the article master data they already use, where it sits attached to the specific pack.
On pharmazie.com the documents are attached to the article record itself, which means you arrive at them from the PZN rather than searching for them by product name:
One honest limitation: the Stand date is the point of the field, not decoration. Fachinformation and Packungsbeilage for the same pack routinely carry different dates, because they are revised through separate variations, and a database copy is a copy. Where a decision turns on the exact approved wording on a given day, the authoritative version is the one published by the competent authority or supplied by the marketing authorisation holder under § 11a AMG. What an aggregator gives you is reach across the whole range and a visible date stamp to check it against.
