Regional review
Europe
European Union buyers work within a harmonised system: EMA and national competent authorities for medicinal products, REACH and CLP for chemical registration and classification, and GMP requirements administered nationally with EudraGMDP records. The single market means a compliant import into one member state moves freely, which raises the evidentiary bar at the point of entry.
Sourcing considerations
For any substance placed on the EU market in volume, REACH registration status and the identity of the registrant or Only Representative determine whether import is possible at all. For active substances, importers must be registered and, for human medicinal use, active-substance import carries written confirmation and QP responsibilities that the buyer, not the supplier, must satisfy.
Documentation requirements
Buyers typically request a specification, a batch COA, an SDS prepared to REACH Annex II with CLP classification, and evidence of the substance registration route. Where an active substance is intended for medicinal use, additional documentation about the manufacturing site and quality system is expected.
Import considerations
Import into the EU requires an EORI-registered importer, correct CN classification, and CLP-compliant labelling in the language of the destination member state. Language-compliant SDS is a frequent cause of delay.
Shipping and transport
Transport follows ADR for road within Europe and IATA by air; cold-chain shipments into the EU generally require a validated packaging configuration and temperature record on arrival.
Questions buyers should ask
- What is the REACH registration status and who is the registrant or Only Representative?
- Is CLP classification and labelling supplied in the destination language?
- Which member state is the point of import?
- Is the material intended for medicinal, research, or industrial use?
- Who acts as importer and, if applicable, QP?