Package leaflet and labelling of medicinal products

The package leaflet is the information document for patients that accompanies the medicinal product, and the labelling comprises the particulars appearing on the outer packaging and on the immediate packaging. Their content is laid down by Directive 2001/83/EC, transposed into the French Public Health Code, and approved by the authority when the marketing authorisation is granted. They must be consistent with the summary of product characteristics and drafted in the official language of the State where the medicinal product is marketed.

Mandatory particulars

The labelling includes, in particular, the name of the medicinal product, its composition in active substances, the pharmaceutical form, excipients with known effect, the method and route of administration, warnings, the expiry date, storage precautions, the batch number and the authorisation number. The name of the medicinal product also appears in Braille on the packaging. The package leaflet sets out, in accessible terms, the indications, contraindications, posology, adverse reactions and precautions for use. Its readability must be verified through consultation with target patient groups. The package leaflet of medicinal products subject to additional monitoring bears an inverted black triangle.

Safety features

Since Directive 2011/62/EU and Delegated Regulation (EU) 2016/161, prescription medicinal products bear, subject to exceptions, a unique identifier and an anti-tampering device. The identifier is verified and decommissioned when the product is dispensed to the patient, by means of a repositories system. These features, designed to combat falsified medicines, complicate any subsequent intervention on the packaging, in particular by a parallel importer, who must replace them with equivalent features.

Packaging and trade mark law

The obligation to draft the labelling and package leaflet in the language of the State of destination leads parallel importers to repackage or relabel medicinal products. The trade mark proprietor may oppose these operations despite exhaustion of rights, unless the conditions laid down by the Court of Justice of the European Union are met. The Court requires that repackaging be necessary for marketing in the importing State, that it not affect the original condition of the product, that it identify the repackager, that it not damage the reputation of the trade mark and that the proprietor be given prior notice. The regime is detailed in the entry on repackaging of imported medicinal products.

Key points

The package leaflet and labelling convey to patients the information in the summary of product characteristics, in the language of the State of marketing and with the safety features required against falsification. Any change to these documents requires a variation procedure. Their role in parallel import places them at the intersection of pharmaceutical law and trade mark law. An importer should check the conditions for repackaging and give notice to the trade mark proprietor before any marketing, and a proprietor should check that repackaged packs comply.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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