# Marketing authorization

*Last updated: 2026-06-26*

> A consignment of pharmaceuticals is held at an EU external border because the importer cannot prove the product is authorised for that market—this is where marketing authorization becomes a customs issue.

A consignment of pharmaceuticals is held at an EU external border because the importer cannot prove the product is authorised for that market—this is where marketing authorization becomes a customs issue. Marketing authorization is the official permission granted by a competent authority allowing a regulated product—such as a medicine, medical device, food additive, or certain vehicle component—to be placed on the market. The authority assesses safety, quality, efficacy, and conformity with applicable standards before granting approval. In the EU, the procedure depends on the product category: human medicines typically follow the centralised route through the European Medicines Agency (EMA), while other products use national or mutual-recognition procedures. Products lacking authorization can be refused entry or seized at the border, making complete documentation a prerequisite for every import. The term refers strictly to product-specific approvals, not to the business licences required for a company to operate in a given market.

**Source:** [https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation](https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation)

## Quick Facts

| Property | Value |
|---|---|
| Term | Marketing authorization |
| Language | EN |
| Word count | 149 |
| Last updated | 2026-06-26 |
| Source | https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation |

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