MAHs must ensure that product labelling and packaging conform to the updated best practices, which may involve modifications to existing labelling SOPs and review processes.
Improved labelling and packaging practices are essential for the safe use of medicines and can significantly reduce the risk of medication errors that affect patient safety.
MAHs must update labelling components to meet new criteria, including a minimum font size of 7 points and essential information requirements regarding the medicine's name, strength, route of administration, posology, warnings, and indications as per the guidance. New packaging must be incorporated into stocked products within six months of approval.
Regulatory Intelligence Lead
Quarterly reviews recommended to ensure ongoing compliance with labelling updates.
Updated recommendations for the design, layout, and content of medicines labelling and packaging, with a focus on risk minimisation and the clarity of safety warnings.
Marketing Authorization Holders (MAHs) must ensure that product labelling and packaging align with these updated best practices to support risk management and safety communications. This may require updates to existing labelling SOPs and artwork review processes.
Pharmaceutical companies may need to budget and allocate resources for user testing
Guidance on user testing may alter the submission process for changes to labeling
MAHs must update labelling components to meet new criteria, including a minimum font size of 7 points and essential information requirements regarding the medicine's name, strength, route of administration, posology, warnings, and indications as per the guidance. New packaging must be incorporated into stocked products within six months of approval.
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on labelling and packaging, requiring Marketing Authorization Holders (MAHs) to align their product labelling with new recommendations. These adjustments aim to improve clarity and risk management to minimize medication errors.
What changed: MAHs must ensure that product labelling and packaging conform to the updated best practices, which may involve modifications to existing labelling SOPs and review processes.
Why it matters: Improved labelling and packaging practices are essential for the safe use of medicines and can significantly reduce the risk of medication errors that affect patient safety.
Practical implication: MAHs must update labelling components to meet new criteria, including a minimum font size of 7 points and essential information requirements regarding the medicine's name, strength, route of administration, posology, warnings, and indications as per the guidance. New packaging must be incorporated into stocked products within six months of approval.
Published from the Firecrawl policy change extraction pipeline.
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