Grey Market
Definition
Supply that is legal somewhere but moves outside the channel a regulated medicine would travel through. The practical consequence is that chain of custody, storage history and identity cannot be verified by the buyer.
What this means for research sourcing
Regulatory status varies by jurisdiction and applies to research supply, not human use. Volta sells to researchers only.
Related Terms in Regulatory
EMA (European Medicines Agency)
The European Union agency that evaluates medicines for the EU market. Its scientific opinions lead to authorisations granted by the European Commission, so approval status in Europe can differ from the FDA's for the same molecule.
Health Canada
The federal department that authorises therapeutic products for the Canadian market and issues a Drug Identification Number to each one. Research-use material is not a therapeutic product and carries no DIN, which is the distinction that governs how peptides may be supplied in Canada.
MHRA (Medicines and Healthcare products Regulatory Agency)
The United Kingdom regulator for medicines and medical devices. It classifies most therapeutic peptides as prescription-only medicines, a category that governs supply rather than possession.
TGA (Therapeutic Goods Administration)
Australia's regulator for therapeutic goods. It places peptides in scheduling categories, commonly Schedule 4, and sets the rules for importation, which differ from both the US and the EU positions.
NMPA (National Medical Products Administration)
China's medicines regulator. Several metabolic peptides have been approved there on the strength of trials run in Chinese populations, so a compound's approval status is a question about a jurisdiction and not about the molecule.
Jurisdiction
The legal territory whose rules apply, which for peptides decides what may be imported, supplied and prescribed. Approval, scheduling and research-supply rules all vary by jurisdiction, so a single claim about legality is almost always incomplete.
Certificate of Origin
A trade document stating the country where goods were produced, used by customs to apply the correct treatment. It describes provenance and makes no statement about composition, purity or quality.
Boxed Warning
The most serious warning the FDA requires on a product label, set apart in a box. It describes a risk identified for an approved product and is part of the label rather than a statement about a substance in general.