Expanding EU & UK Market Access with eQMS & Manufacturer's Import Authorisation (MIA) License

April 4, 2023

This article has been updated since its original publication date.

ProPharma holds its own MIA licenses both in the Netherlands to cover batch importation and Qualified Person (QP) batch certification across all EU countries, and in the UK to cover this market post Brexit.

In today's competitive market, expanding into the EU and UK presents unique challenges for companies seeking to maintain quality standards and compliance across borders.

Recognizing the pitfalls experienced by many international companies when quality activities are undertaken in silos, the EU and UK groups determined to ensure cross-company continuous improvement and leverage a common cloud based electronic Quality Management System (eQMS).

To ensure efficient cross company collaboration, the eQMS that supports the EU and UK MIAs held by ProPharma has some 90% shared Standard Operating Procedures (SOPs) supplemented by country-specific ones.

eQMS & Remote Working

A (QMS) serves as the infrastructure that aligns an organization's individual compliance practices with regulatory requirements, ensuring consistency and effectiveness in their operations.

While paper-based QMS can make for a fast deployment, it often becomes bogged down as an organization develops. A paper-based QMS also has pitfalls, as trending and effectiveness checks are more complicated to perform, and it cannot be easily accessed remotely.

These issues have been amplified due to the complexity that organizations faced during the COVID-19 pandemic, necessitating a shift from purely office-based to remote or hybrid working practices. The regulatory agencies within the EU and UK now accept the concept that QP batch certification does not have to be physically undertaken onsite, but can be carried out remotely provided the QP has secure access to all the appropriate documentation at all times.

eQMS software, while requiring more effort at the start of the implementation and qualification, allow for ready access to all information, and progress of data, independent of the employee's location. It ensures a consistent approach for all sites involved, and accessibility to all information, at all times.

Recognizing the strategic advantage of having Qualified Persons (QPs) positioned across Europe, ProPharma initiated the development an eQMS deployment of the Dot Compliance system to be utilized by all MIA sites (now and in the future). DOT Compliance is a cloud-based eQMS solution for life science companies. This system allows the employees to be based practically anywhere provided they have an internet connection.

Furthermore, the system allows for distinction between the two sites, and their respective MIA licenses, allowing for sharing of data were possible, and limited access to data when required.

Efficiency

By securely granting access to all relevant employees, ProPharma ensures the availability of all ProPharma and client documentation via a cloud-based eQMS. This streamlined approach facilitates smoother documentation review and approval surpassing the complexities of physical paperwork relocation.

Compliance

By using the same eQMS across sites, ProPharma QPs can ensure that any improvement opportunities identified for processes at one site can be rolled out across the organization with ease. ProPharma sites continue to set excellent examples of compliance and efficiency because of ongoing improvements in operations . The system also allows for combined management review operations to be carried out, providing high quality input from a different perspective for each individual site.

Collaboration

Having identified partners to serve as storage and QC importation testing sites across the EU and within the UK, ProPharma can offer a one stop shop system of importation, storage, QC testing, QP batch certification and distribution of both commercial and clinical products to prospective clients.

This makes ProPharma the go-to partner for the launch of products in the EU and the UK.

Contact ProPharma today and let our experienced team guide you through the complexities of expanding your market access, ensuring compliance, and maximizing efficiency.

Contact Us



Meet the Expert

April 12, 2023

Meet the Expert: Cyril van Erp

Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...

Read the Full Article
Compliance Life Science Consulting

November 13, 2013

OIG Signals Importance of Board-Level Compliance Committee in J&J Corporate Integrity Agreement

In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...

Read the Full Article
FDA Life Science Consulting

April 21, 2023

FDA Form 483: Common Pitfalls You Can Avoid

This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...

Read the Full Article