Legal Compliance for Traded Products Procedure

Make legal acceptability a defined supply-approval decision

Before a traded product is approved for supply, the procedure requires the applicable legal requirements to be identified and kept current. Technical / Quality Management reviews the current approved traded product specification together with the supporting evidence relevant to those requirements.

Where applicable, the review covers labelling against the requirements for the known country of sale and, where relevant, the intended country of use; legal compositional requirements against current composition or formulation information and supporting technical evidence; and quantity or volume requirements against declared product information and available evidence of conformity.

Approval is conditional on both parts of that assessment being satisfied: the applicable legal requirements must have been identified, and the available information must provide sufficient evidence that those requirements are met. This preserves a clear distinction between holding product information and demonstrating legal acceptability for supply.

Keep decision authority with Technical / Quality Management

The procedure gives Technical / Quality Management responsibility for identifying and maintaining applicable legal requirements, determining the applicability of labelling, composition and quantity or volume requirements, reviewing specifications and evidence, and confirming legal acceptability.

Senior management provides the resources needed to support verification and maintenance of legal compliance and supports organisational arrangements that allow Technical / Quality Management to withhold approval where compliance cannot be demonstrated. Employees are required to follow the controls relevant to their activities and report missing, inconsistent or uncertain product information or other concerns that may affect demonstrated compliance.

That allocation keeps the legality decision with the function authorised to assess the evidence, while making the reporting of potential information gaps a wider organisational responsibility. 

Reassess approval when the basis of compliance changes

Legal acceptability is reviewed where a relevant change may affect the basis on which a traded product was approved. Technical / Quality Management determines the extent of reassessment from the nature of the change and the product information affected.

Reassessment is initiated where relevant changes affect the country of sale or intended country of use, applicable legal requirements, product specification, composition or formulation, labelling information, quantity or volume requirements, or supporting information used to demonstrate existing compliance. Changes to relevant legislation identified through the Senior Management Commitment & Continual Improvement Procedure are also assessed for their effect on approved traded products.

Where reassessment confirms that the applicable requirements continue to be met, Technical / Quality Management confirms continued approval for supply. Where continued compliance cannot be demonstrated, approval remains withheld until the affected information has been reviewed or corrected and legal acceptability has been confirmed.

Recognise customer-undertaken responsibilities only when contractually clear

The procedure allows a customer-undertaken responsibility to form part of the legality determination only where that responsibility is clearly stated in the applicable contract and applies to the product concerned.

If the contract does not clearly state the responsibility, it cannot be relied upon until the contract has been clarified. A change to the responsibility also requires the legality assessment to be reviewed before continued approval for supply is confirmed. This keeps customer responsibility as a defined input to the legality assessment rather than an assumed allocation.

Withhold supply approval when legal compliance is not demonstrated

Missing, inconsistent or insufficient information prevents approval for supply until sufficient information is available and Technical / Quality Management has confirmed that the product is legally acceptable.

The procedure also distinguishes the legality decision from the controls applied after a problem is identified. Product already under site control that cannot be confirmed as legally acceptable is identified and controlled through the Non-Conforming Product Control Procedure. Where a legality issue is identified after affected product has been placed onto the market, the issue is escalated and managed through the Incident Management, Product Withdrawal & Recall Procedure.

Inspection, sampling, testing or laboratory analysis may support the legal-compliance assessment, but the requirements for generating and reviewing that evidence sit within the Inspection and Laboratory Testing of Traded Products Procedure. 

Connect legal review with controlled specifications, labelling and evidence

The procedure uses current controlled product information as the basis for legal-compliance verification while preserving the boundaries between related FSQMS controls. Approved specifications and associated product information are governed through document control; specification establishment, approval, review and amendment are managed through the Traded Product Specifications Management Procedure; and label-content verification and artwork approval sit within the Product Labelling & Artwork Control Procedure where applicable.

Records of legal-compliance reviews, approval decisions and reassessment decisions are retained and controlled through the Record Completion & Maintenance Procedure. These interfaces connect the legality assessment with controlled information and supporting evidence without attributing those separate control mechanisms to this procedure.

Maintain competence for legal-compliance decisions

Personnel who review, assess, verify, approve, maintain or escalate traded-product legal-compliance controls are required to be trained in the requirements relevant to those activities. The training scope includes the correct application of product-information review controls, recognition of circumstances requiring reassessment or restriction of approval, and the interaction with specification, labelling, testing, non-conforming product and incident-management controls.

Training delivery and record control are managed through the Training & Competence Procedure, keeping competence requirements connected to the wider FSQMS framework.