manufacturing and import license (MIA) and batch certification 

Manufacturing and Import License (MIA) and Batch Certification 

EU and UK Batch Release through the ProPharma MIA License

Navigating both the specific country and general European regulations and requirements to supply medicinal products to the European markets can be a complex challenge. This applies both to Marketing Authorisation Holders (MAH) of approved commercial medicinal products and Sponsors of clinical trials.

In addition to the diverse requirements, Marketing Authorization Holders (MAH) and Sponsors aiming to enter the European markets must develop customized supply strategies for each country and establish a legal entity with a Manufacturing and Importation Authorization (MIA) along with a designated Qualified Person (QP) within the region.

All these tasks can pose challenges, even for the most experienced individuals. The QP holds the responsibility for ensuring that each individual batch has been manufactured and checked in compliance with the laws applicable in the Member State where QP certification takes place, in accordance with the requirements of the marketing or clinical trial authorisation (MA/CTA) and with GMP.

Partnering with the industry-leading compliance experts will help unravel these complexities and enhance business efficiency, resulting in shorter timelines, and reduced overall costs. With our support, you can focus on product development, clinical studies, and commercialization to ensure patient access and safety, while we handle all the complexities of QP services and QP confirmation.

ProPharma holds both EU and UK MIAs, enabling us to assist clients in overcoming intricate challenges of accessing the EU and UK markets. From navigating UK and EU regulations to crafting tailored strategies and QP declaration for each region, we provide comprehensive support. Moreover, our MIAs eliminate the need for MAH/Sponsors to obtain their own licenses and hire a QP in the region.. All of which greatly contributes to ensuring products are released to patients in need across the EU and UK in a prompt and flexible way, particularly if speed to market or budget constraints are concerns. Obtaining your own MIA license typically takes much longer, (over 9 months), while listing your medicinal products on ProPharma's license only requires about 6 weeks.

This streamlined process with ProPharma also leads to a budget reduction of approximately 35%. Additionally, with ProPharma's MIA license, scaling up and down is just a call away, greatly increasing flexibility and reducing costs. Last but not least, with the ProPharma's MIA license you secure a channel with our established partners in third-party logistics (3PL), Contract Laboratory Organisations (CLOs) and CMOs.