Classifying a Product Before Supplement Registration
The short answer
Start with composition, dosage form, intended use, claims and target users. These can change the regulatory route and required documents, so do not infer classification from the trade name.
Three actions to take
- Write a technical rather than promotional product description.
- Separate intended use from medical claims.
- Confirm classification before final packaging design.
Start with the real scope
Start with composition, dosage form, intended use, claims and target users. These can change the regulatory route and required documents, so do not infer classification from the trade name.
- Write a technical rather than promotional product description.
- Separate intended use from medical claims.
Review the points that change the decision
Why product nature, dosage form and claims should be resolved before finalising the label or manufacturer agreement. Record assumptions clearly and separate confirmed data from items that need checking against the official source or actual operation.
- Separate intended use from medical claims.
- Confirm classification before final packaging design.
Turn the review into a usable output
Finish with an owner, version, date and follow-up indicator. This keeps the file useful after delivery and allows it to change with the activity, product or system.
- Write a technical rather than promotional product description.
- Confirm classification before final packaging design.
Need to apply this to your facility?
Share the activity, city and current stage, and we can help define an appropriate work scope.
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