Why has the BSI AMR Kitemark been updated?
Antimicrobial resistance is one of the defining public health challenges of this century. Responsible antibiotic manufacturing sits at the heart of any credible global response to it, and the BSI Minimized Risk of Antimicrobial Resistance Kitemark has become a trusted signal that a manufacturer is doing the work.
Following a comprehensive review, BSI has enhanced the scheme to align with the May 2025 revision of the Antibiotic Manufacturing Standard published by the AMR Industry Alliance. The enhanced AMR Kitemark scheme is effective from 1 January 2026. For certificate holders, the message is deliberately calm. What has improved is the sharpness of the guidance, the proportionality of surveillance, and the clarity of the rules that govern the wider antibiotic supply chain.
The transition timeline at a glance
Four dates shape the transition. In 2022, the Antibiotic Manufacturing Standard was first published, and all BSI AMR Kitemark certifications to date have been assessed against this version. In May 2025, the AMR Industry Alliance published the revised standard. On 1 January 2026, the enhanced BSI AMR Kitemark certification scheme takes effect, and all future assessments are conducted against the May 2025 revision. On 1 January 2028, the transition period ends, and certificates referencing the 2022 standard remain valid only until their existing expiry date.
What has been enhanced?
Four areas carry almost all of the change. Certification scope remains fully aligned with the AMRIA Antibiotic Manufacturing Standard. Primary packaging continues to be covered under audits of antibiotic drug product manufacturing sites, and detailed guidance now also enables the certification of stand-alone primary packaging sites, where applicable. The surveillance framework has been refined so that assessment activity aligns with actual risk and with the corresponding time and cost. Client guidance and the application form have been updated with more detailed information to support your AMR certification journey, end to end.
Your two transition pathways
Existing certificate holders can choose when and how to move to the 2025 version of the standard. Both options are fully supported. Under Option 1, you continue on the 2022 standard: your current certification continues unchanged until its expiry date, with no additional cost and no immediate documentation updates. Under Option 2, you transition to the 2025 standard: your certificate is re-issued to reference the 2025 version following a surveillance audit, while your expiry date and certification cycle do not change. A minimal administrative fee applies for re-issue, and additional assessment time may be required where new or more stringent requirements apply, for example enhanced PNEC values.
A surveillance framework matched to your risk
The refined framework applies customized surveillance pathways based on client-specific scenarios. Three scenarios cover most certificate holders. Where there is no production of the certified antibiotic, a remote surveillance assessment is conducted within 18 months of initial certification. Where there is ongoing production with no operational changes, which is the default for contracts, a remote surveillance assessment is conducted within 12 months. Where there are changes in manufacturing or management systems, a 12-month assessment applies. Clients may declare 'No Production' by contacting BSI and submitting the PF1946 form.
What does this means for you
If you are an active AMR certificate holder, there is no significant impact: you continue with the usual certification cycle, and current certificates referencing the 2022 version remain valid until their expiry date. If your application is currently in progress, the scope has been revised in our systems to the 2025 standard, and Stage-1 and Stage-2 assessments will be carried out against it. If you are a new applicant, contracts will reflect the 2025 standard from the outset, with no separate transition required.
Whether you plan to continue on the 2022 version until expiry or move to the 2025 standard at your next surveillance audit, your BSI account manager can guide the path that fits your operation.
