Labelling: text on the outer and immediate packaging
Labelling is the information Articles 54 and 55 of Directive 2001/83/EC require on a medicine's outer and immediate packaging, from name to batch number.
Directive 2001/83/EC defines labelling in Article 1 as the information on the immediate or outer packaging, and Title V sets what must appear there. Article 54 lists the particulars for the outer packaging, or the immediate packaging where there is none: the name with strength and pharmaceutical form, the active substances per dosage unit, the pharmaceutical form and contents, the excipients that the Commission's excipients guideline requires to be declared, the method and route of administration, the warning to keep the product out of the sight and reach of children, any special warning, the expiry date, storage precautions, disposal precautions, the name and address of the holder, the marketing authorisation number, the batch number, instructions for use for non-prescription products and, for most prescription medicines, the safety features required by the Falsified Medicines Directive. Article 55 allows a shorter set on blisters and on small immediate packaging, and Article 56a adds the name in Braille on the outer packaging.
The labelling is Annex IIIA of the product information and follows the QRD template, which also fixes standard abbreviations such as EXP and Lot. Articles 57 and 62 allow national particulars and pictograms, kept in the Blue Box, and Article 63 requires the text in the national language or languages, although the authority may accept several languages on one pack as long as the content is the same. Any change to the labelling that is not connected with the SmPC goes through an Article 61(3) notification; a change connected with the SmPC travels with the variation.
What goes wrong: the excipients list on the pack does not match the SmPC after a composition change; the strength expression differs between carton, blister and SmPC; the holder's name is not updated within the transition period after a transfer; small-pack exemptions are claimed for packs that are not small; multilingual packs leave no room for the Blue Box of every market; and artwork is approved from a PDF that does not show the final print size, so the minimum font size in the readability guideline is missed. Serialisation adds a second class of fault, where the human-readable code and the 2D barcode do not agree.
Used in
Packaging teams check carton and blister artwork against the approved labelling text in Print Proofreader before the print run is released.
Related terms
- Package leaflet: patient information leaflet in the packThe package leaflet is the patient-facing text in every medicine pack, required by Articles 58 and 59 of Directive 2001/83/EC and based on the SmPC.
- SmPC: summary of product characteristicsThe summary of product characteristics (SmPC) is the approved document that tells healthcare professionals how to use a medicine safely and effectively.
- Mock-ups: full-colour drafts of packaging and leafletMock-ups are full-colour, actual-size drafts of the outer packaging, immediate packaging and leaflet that authorities review before a medicine is marketed.
- Braille: product name in Braille on the outer packagingBraille on medicine packs is required by Article 56a of Directive 2001/83/EC: the name, and strength where needed, in Braille on the outer packaging.
- Unique identifier: serialised code on prescription medicine packsThe unique identifier is the serialised 2D code on a prescription medicine pack that pharmacies verify against the EU repository before supply.
Last updated