Import authorisation for medicinal products

The import of medicinal products is governed by rules that vary according to the origin of the product and the status of the operator. From a third country, import into the Union is an activity treated as manufacturing, which requires a manufacturing authorisation and batch release by a qualified person, in accordance with Directive 2001/83/EC.

Import from a third country

An importer established in the Union must have an authorised establishment and have each imported batch tested, unless a mutual recognition agreement exists with the country of manufacture. The qualified person certifies that the batch has been manufactured in accordance with good manufacturing practice at least equivalent to that of the Union and that it complies with the authorisation. Imported active substances are subject to a separate regime, which generally requires written confirmation from the authority of the exporting country.

Import from another Member State

Intra-Union movement of a medicinal product by its marketing authorisation holder, where the product is already authorised in the Member State of destination, does not require a separate import authorisation. Where the product is authorised in the Member State of origin and the operator does not hold the French authorisation, parallel import requires a specific authorisation, granted on the basis that the imported product is identical to the medicinal product authorised in France. For medicinal products authorised under the centralised procedure, the operator falls under the parallel distribution regime, which requires a notification to the European Medicines Agency. Other special regimes exist, in particular for medicinal products imported under early access (accès précoce) or to address a shortage.

Customs control and intellectual property rights

Customs authorities may detain medicinal products suspected of infringing a patent, a supplementary protection certificate or a trade mark, on the basis of Regulation (EU) No 608/2013 and an application for action filed by the right holder. The Court of Justice has held, however, that goods placed in transit do not infringe a patent in force in the Union merely by passing through it, unless it is established that they are intended to be marketed there. Detention opens a short period within which proceedings on the merits must be brought.

Key points

The applicable regime depends on the origin of the medicinal product and the status of the operator. From a third country, import amounts to manufacturing and requires batch release in the Union. Between Member States, parallel import requires a specific authorisation. A right holder concerned about infringing imports would be well advised to file an application for customs action covering its patents, certificates and trade marks, and to keep it up to date.

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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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