Supply classifications

Approved medicine

A medicinal product that a regulator has assessed and authorised for a stated indication, in a stated form, by a stated route, in a stated territory. The authorisation attaches to a specific finished product made by a specific holder to a specific specification — not to the molecule in the abstract.

Three consequences follow, and all three are routinely missed. Authorisation in one territory says nothing about another. Authorisation of one brand says nothing about another brand of the same molecule. And authorisation of one route, such as an oral tablet, does not extend to another, such as an injection.

Supplying the active substance as a manufacturing material is a different activity from placing an authorised medicinal product on a market. Holding the former confers nothing in respect of the latter.

Investigational compound

A compound under clinical development that holds no marketing authorisation anywhere. It has not been assessed as safe or effective by any regulator, because that assessment is what an authorisation represents and it has not happened.

Human administration of an investigational compound outside an authorised clinical trial is not a lawful supply route. Regulators in several jurisdictions have published enforcement positions on precisely this point, and one developer has stated in writing that its investigational molecule cannot be legally sold or marketed for human use.

Positive trial results do not change this. A compound with reported phase 3 results and no filed application is in exactly the same regulatory position as one with no results at all.

Research and manufacturing use

Material supplied to a business as an input to research or to manufacturing, rather than to a person for administration. This is the basis on which HelixEVO supplies.

A label is not a legal status. Regulators have stated explicitly that describing a product as being for research use only does not change its regulatory status, does not permit importation, and does not remove supply or advertising obligations. Enforcement action has been taken against vendors whose products carried research-use labelling where the surrounding claims established an intended human use.

What determines the position is the whole picture: what is supplied, to whom, with what documentation, and what is said about it.

Cosmetic ingredient

A substance regulated under cosmetics law rather than medicines law. The applicable framework is ingredient safety assessment at stated concentrations in stated product types — not marketing authorisation.

An expert-panel conclusion that an ingredient is safe as used is not an approval, and it is not a finding of efficacy. It also does not transfer between substances: one assessment covering a family of copper tripeptides states expressly that its conclusions do not apply to other peptide sequences, and a closely related compound in this knowledge base is therefore not covered by it.

Responsibility for the safety assessment of a finished cosmetic product rests with the responsible person placing that product on the market, not with the ingredient supplier.

Novel food and food supplement ingredient

In the European Union a food not consumed to a significant degree before 15 May 1997 requires authorisation before it may be placed on the market. Authorisation is a Commission implementing act entering the food in the Union list with binding categories, maximum levels, target population and labelling.

A favourable scientific opinion is a risk assessment and is not authorisation. The gap between the two is real and can run to months or years, and a regulator may also depart from the scientific conclusion in either direction — one compound in this knowledge base was authorised for a category the assessment had not supported, and refused for another it had.

Status does not transfer between related substances. Of the three forms covered here, one is authorised, one is unauthorised and actively enforced against, and one is recorded as not novel in supplements on the basis of historical use — a non-binding record that places the evidential burden on the business, not on the catalogue.

Unlicensed and unapproved products

A product with no marketing authorisation in a territory where one is required. Unapproved is not the same as prohibited, and the difference matters: a substance may be unapproved while also being under active evaluation, subject to a named-patient or special-import derogation, or simply absent from every register.

Those are distinct regulatory states and this knowledge base keeps them distinct. Where the position could not be established from a primary source, it is recorded as unverified rather than as an absence.