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Indicator 4.4.6
by Contact on 8 October 2026
Requirement
The UoC shall only use non-therapeutants registered or approved by applicable legal requirements and shall apply them according to the manufacturer’s instructions.
How Do I Interpret This Requirement?
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When using non-therapeutants:
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Verify product registration or approval (e.g. identify regulatory authorities, check official database, contact regulatory authorities in case of uncertainties, consult association, verify through manufacturers or suppliers, check for local regulations).
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Review product labels and documentation. Approved products usually have specific registration numbers or approval statements that indicate their status.
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Follow the manufacturer’s instructions to ensure their effectiveness and safety.
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Evidence of Implementation
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Verification of product registration or approval.
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Records:
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The name and amount of the product;
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The reason to use;
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The dosage and administration instructions.
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Auditors Should Confirm
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Adequate level of knowledge related to product registration or approval and cross-checking with use records.
