Legal
Export and legal restrictions
Summary
The Products are laboratory reagents. Their legal position differs from one jurisdiction to another, and in several jurisdictions the supply of these substances to a private individual is a criminal matter. The restrictions below are conditions of supply, not guidance.
No marketing authorisation
No Product listed by the Supplier holds a marketing authorisation as a medicinal product in any EU/EEA Member State or in the United Kingdom, except where a product page states otherwise for the compound concerned. No Product is offered for, and no Product may be used for, any human or veterinary application.
Destination restrictions
Supply is limited to the destinations published for each compound. The published list operates as an allow-list: a destination that is not listed is not served, and the checkout country selector is generated from the allow-list for the compound ordered and cannot be altered by the Buyer.
Destination policy is determined by the medicines and anti-doping law of the destination state, not by carrier coverage. Destinations declined for one or more compounds include:
| Destination | Basis |
|---|---|
| Germany | Arzneimittelgesetz §73; Anti-Doping-Gesetz |
| France | Code du sport L.232-9 |
| Italy | Legge 376/2000 |
| Sweden | Lag 1991:1969 |
| Denmark | Lov 232/1999 |
| Spain | Código Penal art. 362 quinquies |
| Poland | Anti-doping Act 2017 |
| United Kingdom | Human Medicines Regulations 2012 reg. 46 |
| United States | Federal Food, Drug and Cosmetic Act — unapproved new drug |
| Australia, Japan, Singapore, United Arab Emirates, Switzerland | National medicines control legislation |
Regulation (EU) 2018/302 on unjustified geo-blocking does not require a trader to supply into a territory where supply would breach a prohibition applying in that territory. Art. 1(5) is express on the point. The Supplier geofences for legality.
Sanctions and embargoes
No supply is made to, or for the advantage of, a person or entity designated under EU restrictive measures, the United Kingdom sanctions regime, or the United States OFAC Specially Designated Nationals list. No supply is made into a comprehensively embargoed jurisdiction.
The buyer name and the destination country are screened at order time. Where screening returns a hit, or cannot be completed, the order is declined. An order is never released on the basis that a screening service was unavailable.
Export control
The Products are not, at the date of this document, listed in Annex I to Regulation (EU) 2021/821 on dual-use items. This does not relieve the Buyer of its own obligations, and the catch-all controls in that Regulation may apply according to the end use or the end user.
The Buyer warrants that it will not export, re-export or transfer any Product in breach of applicable export-control or sanctions law, and that no Product will be supplied for a use connected with chemical or biological weapons.
End-use declaration
A signed end-use declaration on institutional letterhead is required before an account reaches approved status, and a copy accompanies each cross-border consignment as standard customs practice. The declaration records the institution, the principal investigator, the intended in vitro research use and an undertaking not to transfer the Product onward.
Tariff classification
Each Product is classified for customs purposes with a customs broker, and Binding Tariff Information is obtained where the classification is open to argument. The classification applying to a Product is stated on its product page. Misclassification is a leading cause of consignment seizure and is managed accordingly.
Quantity ceilings
A ceiling applies to the quantity of each compound supplied to one account over a rolling thirty-day period. Research quantities are milligrams. An order that would exceed the ceiling is declined, and repeated approaches to the ceiling are examined.
Responsibility of the Buyer
The Buyer is responsible for establishing that possession, importation and use of a Product are lawful in its own jurisdiction and for its own intended research use, and for holding any licence, authorisation or notification required there. The Supplier's willingness to supply to a destination is not advice that receipt is lawful in that destination.
Breach
A breach of this document entitles the Supplier to cancel the order, suspend the account and decline future supply. Where a breach suggests onward supply for human use, the Supplier will notify the competent authority in the relevant jurisdiction.
Contact
Export and restriction enquiries: [[REGULATORY_CONTACT_NAME]] · support@dohrna.com · +63 927 499 4459.