Defined terms in the registry — page 5
195 documents of type defined term.
Documents
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Repeated freezing and thawing of a solution. Concentrates solutes in the shrinking liquid fraction, drives pH excursion as buffer components crystallise differentially…
30 Jul 2026 -
The time a reconstituted preparation may be stored and used, supported by stability-indicating data on that presentation. The Institute publishes no in-use claim for any…
30 Jul 2026 -
Loss of peptide to container and syringe surfaces, material at low concentration in the absence of a surfactant. A source of content loss that no certificate reports.
30 Jul 2026 -
The document accompanying a batch, reporting the determinations made and the results obtained. Its value depends entirely on which fields it carries and whether the…
30 Jul 2026 -
The Institute’s specification of the fields a certificate must carry for a purity or content claim to be interpretable. Fields are classified as critical or recommended…
30 Jul 2026 -
The linkage between a certificate and the specific batch supplied, by batch identifier and date. A certificate that cannot be linked to the material in hand is a…
30 Jul 2026 -
Analysis performed by a laboratory independent of the supplier. Stronger evidence than a supplier-issued certificate, and weaker than analysis of an independently…
30 Jul 2026 -
The record of where an analysed sample came from and who selected it. A supplier-selected sample and an independently purchased one are different classes of evidence and…
30 Jul 2026 -
In an Institute supplier dossier, a determination supported by documentation the Institute has examined. Verification is of the documentation and never of the product…
30 Jul 2026 -
In an Institute supplier dossier, a claim for which the Institute has looked for supporting documentation and not found it. Distinct from not assessed.
30 Jul 2026 -
In an Institute supplier dossier, an attribute the Institute did not examine. Carries no implication about the attribute and is recorded so that a reader can distinguish…
30 Jul 2026 -
A supply designation indicating that material is not manufactured under a marketing authorisation and is not approved for human or veterinary use in any jurisdiction. A…
30 Jul 2026 -
A regulated system of controls over manufacture, in which a claim of compliance is meaningful only where an inspecting authority is named. An unverified compliance claim…
30 Jul 2026 -
The international standard for the competence of testing laboratories. Accreditation is granted for named tests within a defined scope; a laboratory accredited for one…
30 Jul 2026 -
Permission from a competent authority to place a medicine on the market for a stated indication. Specific to product, indication, presentation and jurisdiction.
30 Jul 2026 -
Holding no marketing authorisation for the use in question. A compound may be approved in one indication and unapproved in another, and approved in one jurisdiction and…
30 Jul 2026 -
Use of an authorised product outside the terms of its authorisation. A regulated product used outside its licence, and distinct from an unapproved product, though the…
30 Jul 2026 -
The most prominent warning a competent authority can require in product information. Signals regulatory concern; does not itself establish that the risk is realised in…
30 Jul 2026 -
The collection and analysis of reports of suspected adverse reactions after authorisation. Establishes that an event has been reported and, for an event named in a…
30 Jul 2026 -
Increased reporting of an adverse event following publicity about it, which inflates a pharmacovigilance signal without any change in incidence.
30 Jul 2026 -
The Anatomical Therapeutic Chemical classification assigned by the World Health Organization. Assigned to authorised substances; its absence indicates that no…
30 Jul 2026 -
A unique identifier assigned to a chemical substance by the Chemical Abstracts Service. An identifier and not a statement of legal or quality status.
30 Jul 2026 -
A preparation made by a pharmacy for an individual patient. Subject to a different regulatory framework from a manufactured medicine, and not equivalent to an authorised…
30 Jul 2026 -
The quarterly period in which the Institute ratifies documents. Every document carries the cycle in which its current version was ratified.
30 Jul 2026 -
Approval of a document by the assessment committee following external review and, where applicable, the disposition of a public comment period. A document is published…
30 Jul 2026 -
A defined window during which formal submissions may be made on a draft. Every submission is signed, carries a declared interest, receives a secretariat response and is…
30 Jul 2026 -
The Institute’s recorded decision on a submission: accepted, accepted in part, noted without amendment, or not accepted with a stated reason. Submissions that are not…
30 Jul 2026 -
A financial or non-financial relationship disclosed by a person contributing to an Institute document or submitting to a comment period. A declaration is not a…
30 Jul 2026 -
An Institute-constructed trial record representing an instalment, sub-study or regional extension of a real development programme, published to carry a methodological…
30 Jul 2026 -
A marker applied to any figure, worked example or value the Institute has constructed for teaching purposes rather than extracted from a source. The boundary between…
30 Jul 2026 -
The cycle in which a document is scheduled for re-examination. A document past its next-review date without a new version is flagged in the registry.
30 Jul 2026 -
The edition of a document. Any change to a number, a rating or a conclusion increments the version; superseded versions remain published, marked and linked from the…
30 Jul 2026 -
The record of every correction made to a published document, including corrections that do not change a conclusion. Published in full so that a reader can judge which…
30 Jul 2026 -
The record of third-party data submitted to the Institute, what was submitted, by whom, and whether it was used. Data submitted and not used are recorded with the reason.
30 Jul 2026 -
The stable reference for an Institute document, of the form CEI-XX-nnn. A document that changes type retains its original identifier so that citations to it remain…
30 Jul 2026
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