What goes into a registration dossier
Before a supplement or cosmetic can be sold in many markets, an authority reviews a file describing exactly what it is and how it is made. These are the documents that file is built from.
MAS Pharma team
Requirements differ between authorities, and they change. The core of most dossiers is still the same set of documents, each answering one question about the product.
Composition: what is in it
The full formula: every ingredient, its quantity per unit or per 100 g, and its role, whether active, filler, preservative or flavour. Everything else in the dossier refers back to this document.
Specification: what it must measure up to
A list of tests for the finished product, each with its acceptance limit. Typical tests cover appearance, the amount of each active, and properties that depend on the form, such as pH for a cream, disintegration for a tablet or microbial limits for a syrup.
Method of analysis: how each test is done
For every test in the specification, the method used to run it, so the authority, or a laboratory acting for it, can repeat the result.
Certificate of analysis: proof for one batch
The results of those tests for a specific batch, set against the limits. It shows the specification is met in practice, not only on paper.
Stability: how long it stays within specification
The product is stored under set conditions of temperature and humidity and tested at intervals. The results support the shelf life printed on the pack and the storage advice beside it.
Method of manufacture: how it is made
The steps from weighing to packing, the equipment used and the checks made along the way.
Certificates and pack
- The manufacturer's certificates. Ours are ISO 22000 and GMP.
- The label, carton and leaflet artwork exactly as it will be printed.
- For some authorities, a certificate of free sale from the country of manufacture.
Why the documents have to agree
Most questions from an authority come from documents that contradict each other: a dose on the label that differs from the composition, or a test in the certificate that is missing from the specification. When the people who wrote the formula also wrote the methods and ran the stability study, the file holds together.
Need a dossier for a new market? Tell us which one and the product you want to register.
Keep reading
FormulationCream, syrup, tablet, powder or effervescent: choosing a dosage formThe same active can reach the shelf in several forms. The right one depends on who takes it, how big the dose is, and how it has to survive in storage.
PackagingPreparing artwork for a private-label packCartons, labels and leaflets are where a formula meets the shelf. A few decisions made early save a reprint later.