To supply antibiotics to the NHS under the NHS antimicrobial product subscription model, you must demonstrate your commitment to managing AMR environmental risks during the manufacturing of antibiotics by obtaining the BSI Kitemark for Minimized Risk of AMR Certification. This certification is a requirement for the NHS subscription model tender, and you will need to either:
a) Provide evidence that certification has been achieved, or
b) Submit a delivery plan to achieve certification that is acceptable to the NHS before a contract is awarded.
The certification process is straightforward, and BSI is here to guide you every step of the way. Learn how to achieve certification and meet NHS requirements by reading the details below.
What is the BSI Kitemark for Minimized Risk of AMR certification?
The BSI Kitemark for Minimized Risk of AMR certification is a distinguished program aimed at mitigating the threat of antimicrobial resistance (AMR) through environmental controls. It confirms that antibiotic manufacturers effectively manage and reduce the environmental impact of antibiotic waste discharge. By adhering to rigorous standards, this certification demonstrates a commitment to responsible manufacturing practices and ultimately contributes to safeguarding antibiotic efficacy for future generations.
What standard does the BSI Kitemark for Minimized Risk of AMR certification certify against?
The BSI Kitemark for Minimized Risk of AMR certification is based on the AMR Industry Alliance’s Antibiotic Manufacturing standard. This standard requires manufacturers to control emissions of antibiotic residues from their waste streams, ensuring they remain within safe Predicted No Effect Concentration (PNEC) thresholds. Achieving this certification signifies adherence to global best practices for managing AMR risks associated with antibiotic manufacturing.
Why has the BSI Kitemark for Minimized Risk of AMR certification been introduced?
AMR is identified by the World Health Organization (WHO) as one of the top ten global health threats, compromising the effectiveness of antibiotics. The BSI Kitemark for Minimized Risk of AMR certification addresses this pressing issue by ensuring manufacturers contribute to mitigating the threat of AMR and meet stringent environmental standards.
This certification is a requirement for NHS antimicrobial product subscription model and is also recognized by antibiotic tenders in Nordic countries and other healthcare procurement requirements. It is also one of the priority recommendations in National Action Plans on AMR, including the recently released 2024-2029 UK National Action Plan on AMR (recommendation 9.4).
How to certify to the BSI Kitemark to meet NHS antibiotic subscription model tender requirements
To qualify for NHS contracts under the NHS antimicrobial product subscription model, antibiotic manufacturers must secure the BSI Kitemark for Minimized Risk of AMR certification. This certification is required for all manufacturing sites involved in producing the relevant antibiotic, including drug product and Active Pharmaceutical Ingredient (API) sites, as well as any sites from contract manufacturing suppliers.
Follow these steps to achieve certification and meet NHS requirements:
Application and self-certification:
- Required by the NHS procurement process:
- During the NHS contract application process, you must self-certify your commitment to obtaining the BSI Kitemark for Minimized Risk of AMR.
- The subscription model uses the standard NHS procurement process and is advertised on the GOV.UK Find A Tender service and Contracts Finder Notice site.
- Required by BSI:
- Submit an enquiry to BSI on this webpage to receive the Kitemark application form. You will automatically receive a link to the application form when an enquiry is submitted, enabling you to enter your antibiotic and site information to start the process.
- Once BSI receives the completed application form, BSI will provide a letter of intent to the applicant for them to provide to the NHS, indicating their commitment to achieving the Kitemark.
Delivery plan submission:
- Required by the NHS procurement process:
- Before the NHS contract begins, you must provide a detailed delivery plan to the NHS outlining how you will achieve the BSI Kitemark for Minimized Risk of AMR certification.
- Required by BSI:
- Each applicant must be formally contracted with BSI for the certification process.
- Once the BSI Kitemark contract is signed, BSI will provide a full delivery plan to the applicant for them to provide to the NHS.
Certification achievement:
- Required by the NHS procurement process:
- Achieve the BSI Kitemark for Minimized Risk of AMR certification within 12 months of the contract start date.
- Support from BSI:
- Once certified, the applicant can download their Kitemark certificate and provide it to the NHS. The applicant is also permitted to display their Kitemark on their product, website, and in tender submissions.
- The NHS can verify the validity of the certificate through the publicly available BSI directory.
Certification process overview:
The Kitemark certification is valid for a 3-year cycle and involves the following steps:
- Initial assessment:
- Stage 1: Virtual assessment to review documentation and assess the site's capability to meet certification requirements.
- Stage 2: On-site assessment to evaluate the effectiveness of procedures through an audit, including validation of adherence to Predicted No Effect Concentrations (PNECs) via methods like mass balance, sampling and analysis, and/or Zero Liquid Discharge.
- Non-conformities:
- Minor: Requires root cause analysis and Corrective and Preventive Actions (CAPA) submitted within 30 days for review and acceptance.
- Major: Requires root cause analysis and CAPA, plus an additional assessment to confirm effectiveness.
- Annual surveillance:
- Following successful recommendation for certification, an annual ongoing surveillance assessment is conducted to ensure ongoing compliance and capability.
- Full recertification occurs every 3 years.
By following these steps and maintaining ongoing compliance, you will meet the NHS tender requirements and demonstrate your commitment to managing antimicrobial resistance effectively.
What are the benefits of BSI Kitemark for Minimized Risk of AMR certification?
This certification presents a wide range of benefits to antibiotics manufacturers:
- Unlock Opportunities: Certification makes you eligible for NHS antimicrobial product subscription model by meeting eligibility requirements.
- Global Recognition and Trust: The Kitemark is a globally acknowledged symbol of trust and commitment, enhancing your company’s reputation among healthcare procurers, investors, and patients. You can feature the Kitemark on your website and in the healthcare system and client tender submissions.
- Enhanced Environmental Stewardship: Certification highlights your commitment to controlling and reducing antibiotic residues from manufacturing waste, contributing to global AMR efforts.
- Future-Proofing Your Operations and Your Supply Chain: The certification process ensures your manufacturing practices and suppliers are resilient to future regulatory changes and client expectations.
How do I find out more?
Furthermore, our team of experts is here to assist you throughout your certification journey. Please fill out the form on this page to access your application form and register any further queries. We will be in touch to provide the support you need.
We also have a set of frequently asked questions available here.
