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.
Partner with us!
ProPharma can perform QP services and Batch Certification under its own MIA licenses for pharmaceutical and biotech clients, facilitating the launch of clinical trials or commercial products to the European and UK markets, additionally, with our QP confirmation and release expertise, we support exporting products from the EU (e.g., to the United States). This applies to both new and existing products.
Listing your products on the ProPharma MIA licenses gives you access to skilled and experienced QP's for multiple types of products/formulations including ATMPs, Biologics, Radiopharmaceuticals, vaccines and small molecules for both IMP and commercial products.
|ProPharma MIA License
|Client MIA License
|Timeline: 6-10 Weeks
|Timeline: 9 Months or longer
|No need to hire FTEs or host agency audits
|Need to hire FTE (at minimum 1 QP and QA Officer) which could prove to be limiting when diversity of products and locations
|Flexibility scaling up and down
|Rigidity in scaling of capacity, which affects delivery and costs
|Established partnership with 3PLs, CLOs, and CMOs
|3PLs, CLOs, CMOs to be identified, adding to timeline
Manufacturing and Import License (MIA) and QP Batch Certification
Accelerate Product Launch and Market Access with Qualified Person, QP Certification and QP Declaration
Embarking on the journey to gain access to European markets involves navigating both the specific country and general European regulations and requirements, which can be quite a complex undertaking. In addition to the varying requirements, Sponsors looking to enter the EU/UK markets must create tailored market access strategies per country and establish a legal entity with a QP in the region. All of these tasks can be extremely challenging, even for the most experienced individuals.
ProPharma offers QP Batch Certification services under its own MIA licenses for pharmaceutical and biotech clients launching products to the European market (Schengen countries). Moreover, we offer release services for exporting products from the EU/UK markets (e.g., to the United States) and for existing products.
Immediate Market Access with ProPharma's MIA License
By partnering with the leading industry compliance experts, you can navigate through the complexities, improve business efficiency, shorten timelines, and reduce overall costs in the UK. This will allow you to focus on product development, clinical studies, and commercialization to support patient access and safety.
With ProPharma's MIA license you can effectively overcome the challenges of accessing the EU markets such as navigating country and EU regulations, creating tailored strategies per country, and lifting the Sponsor's need to obtain its own MIA license with a QP in the region. As a result, products can be released to patients in need across the EU in a quick and flexible way.
ProPharma's EU and UK MIA Timeline
ProPharma has been obtaining and expanding its EU and UK MIA license capabilities since 2020, adding extensions to support our clients and their diverse types of products.
2024 & Beyond
First MIA Client
ProPharma awarded with Import and QP certification services for a biological parenteral commercial product under ProPharma's MIA license.
First MIA License Obtained in The Netherlands
MIA license issued in The Netherlands for biological parenteral commercial products.
New QPs Added
New Qualified Persons added to the MIA license in The Netherlands, for a total of seven (7) QPs.
UK MIA License and EU Expansion
Second MIA license in the UK issued for Importation and QP Certification of non-sterile products.
Five (5) new clients added to MIA license in The Netherlands
IMP and Radiopharmaceuticals
Import and QP Certification of IMP and Radiopharmaceutical added to MIA license in The Netherlands.
Total of nine (9) QPs in The Netherlands.
First MIA IMP UK Client Signed
First MIA UK Commercial Client Signed
Extension of the EU license to include IMP biologics
Extension of the EU License
Pending to include commercial and IMP ATMPs and MIA IMP UK granted to oversee importation of IMP from EU which allows joint up services with the EU.
2024 & Beyond
ProPharma's MIA license will continue to expand as new clients and product types are onboarded.
Need Help Expediting Your Product Launch in the EU and UK?
Contact us to see how we can support your quest to get your products to patients in need throughout Europe.