· 10 min read
The possibility of having a Manufacturer's and Importer's Authorization (MIA) suspended strikes fear into the hearts of pharmaceutical executives everywhere. License suspensions can have considerable consequences for the security of the company’s workforce. It can cause reputational damage and have an impact on revenue.
In this case study, we examine a client NSF supported to address the significant issues that resulted in an MIA suspension and outline how we helped bring them back to full manufacturing.
We look at:
European regulators have the power to suspend, vary or evoke an MIA from a company if the regulator identifies critical or major findings during an audit1.
To ensure compliance, MIA license holders must:
Regulatory inspectors who identify critical or numerous findings can move swiftly to issue a suspension, although the timing does depend on the seriousness of the findings and the risk to patients. Manufacturing must cease as soon as a suspension of an MIA is issued unless it is a partial suspension. Furthermore, the suspended MIA license is listed on the EUDRAGMP database and other regulatory authorities are informed. Suspension can last for a considerable period, often for months.
NSF was called to work with a UK-based pharmaceutical manufacturer following the suspension of their MIA by the UK regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA).
A GMP inspection of the site had found:
Initially, the company began responding to inspection findings. However, it quickly became evident that they did not have the expertise required to manage a project of this scale. The company’s management engaged NSF to manage the project and help the manufacturing site resume operations with MIA reinstatement.
NSF worked over 18 months to bring the site back into compliance and, importantly, helped provide continuity to the company as staff turnover was high during that time. NSF handled multiple elements of this complex project, including:
During this significant undertaking, NSF experts worked to bring the site back to manufacturing and to secure the company’s MIA reinstatement.
The company’s license was reinstated after 12 months, and they could supply products from the site six months later. In total, the company could not supply products from the site for 18 months.
NSF’s multi-disciplinary team spent a significant period working with the company to remediate the issues and reinstate the MIA license. When asked about lessons learned and observations from the project, our experts identified five key takeaways:
In this instance, the company was aware that they were not prepared or capable of effectively managing the issue at an early stage. They called on NSF’s expert team to guide them through a lengthy process, ensuring the reinstatement of their MIA. The NSF multi-disciplinary team has put the company and its staff on a secure footing, ready to supply their products to market.
NSF can help your company prevent issues like this from happening, or, if the worst happens, we can work with your company to get your MIA reinstated. Contact us today by using the form below.
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1Medicines and Healthcare Products Regulatory Authority (MHRA), Notes for Applicants and Holders of a Manufacturer’s Licence, MHRA Guidance Note 5, available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/405883/Medicines_-_notes_for_applicants_and_holders_of_a_manufacturer_licence.pdf (2014).