As of August 2024, antibiotic manufacturers aiming to secure NHS contracts under the NHS antimicrobial product subscription model must comply with a specific environment manufacturing standard designed to contribute to mitigating the threat of antimicrobial resistance (AMR). To evidence the compliance, suppliers must obtain the BSI Kitemark for Minimized Risk of AMR certification. This certification not only aligns with NHS requirements but also enhances your commitment to environmental responsibility and countering the threat of AMR.
In this blog we outline the steps each antibiotic manufacturer has to take to be compliant to access opportunities using the NHS antimicrobial product subscription model.
Why is the BSI Kitemark for Minimized Risk of AMR certification crucial?
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 does the certification entail?
The BSI Kitemark certification is based on the AMR Industry Alliance’s Antibiotic Manufacturing Standard. This standard requires the control of antibiotic residue emissions from waste streams, ensuring they stay within safe Predicted No Effect Concentration (PNEC) thresholds. Achieving this certification signifies adherence to global best practices for managing AMR in the environment and aligns with national action plans, including the recent UK National Action Plan on AMR.
Aligning with NHS requirements
The NHS antimicrobial product subscription model is a pioneering program that pays companies a fixed annual fee for antimicrobials based on their value to the NHS, rather than the volumes used. This innovative approach encourages essential advancements in pharmaceutical antimicrobial research and development while setting stringent requirements to drive real progress on AMR in the Environment. The NHS tender responsible manufacturing requirement mirrors the recommendation from the 2024-2029 UK National Action Plan on AMR to implement the Antibiotic Manufacturing Standard and adopt the BSI Kitemark.
Steps to achieve certification for NHS antimicrobial product subscription model tenders
Securing the BSI Kitemark for Minimized Risk of AMR certification involves several key steps:
1. Application and Self-Certification:
- NHS Requirement:
- During the NHS contract application process, 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.
- BSI Requirement:
- Submit an enquiry on the dedicated BSI/NHS AMR certification webpage to receive the Kitemark company information form. You will automatically receive a link to the form upon enquiry submission to enter your antibiotic and site information.
- BSI will provide a letter of intent to submit to the NHS, indicating your commitment to achieving the Kitemark.
2. Delivery Plan Submission:
- NHS Requirement:
- Before the NHS contract begins, provide a detailed delivery plan to the NHS outlining how you will achieve the BSI Kitemark for Minimized Risk of AMR certification.
- BSI Requirement:
- Formally contract with BSI for the certification process.
- BSI will provide a full delivery plan to submit to the NHS once the contract is signed.
3. Certification Achievement:
- NHS Requirement:
- Achieve the BSI Kitemark for Minimized Risk of AMR certification within 12 months of the contract start date.
- Support from BSI:
- Once certified, download your Kitemark certificate and provide it to the NHS. Display the Kitemark on your product, website, and in tender submissions.
- The NHS can verify the certificate's validity through the publicly available BSI directory.
Benefits of obtaining the BSI Kitemark certification
Obtaining the BSI Kitemark for Minimized Risk of AMR certification offers several advantages:
- Unlock opportunities: Eligibility for NHS antimicrobial product subscription model and other healthcare tenders.
- Global recognition and trust: Enhance your company’s reputation with a globally recognized symbol of commitment.
- Enhanced environmental stewardship: Showcase your dedication to reducing antibiotic residues and contributing to global AMR efforts.
- Future-proofing: Ensure resilience to future regulatory changes and client expectations.
How do I get started?
Getting started with the BSI Kitemark for Minimized Risk of AMR certification is easy with our dedicated landing page and suite of resources. Here you will find further information as well as an enquiry form to access the application form to start the process of certification.
Don’t miss out on this crucial step to meet NHS subscription model tender requirements and enhance your commitment to responsible manufacturing of antibiotics and mitigating the threat of AMR.
