Request for Information
Product list, target markets, storage model and documentation readiness.
MIA for EU Importation and Qualified Person Support
Manufacturing and Import Authorisation
Plan your importation route with us.
We review your product and the applicable MIA scope before agreeing the activities, quality agreements and QP/RP responsibilities needed for your project.
Licensed Route
Customer products can be added to the MIA scope after the right product, quality and partner framework is documented.
QP/RP Accountability
Primary QP, backup QP and RP/GDP interfaces are defined around batch certification, storage, transport and release evidence.
Inspection Readiness
The operating model connects QTA, QP-to-QP agreements, supplier qualification, eQMS records and authority expectations.
// Belgian MIA route
Discuss MIA access
Use QP Pro Services' Belgian MIA for EU importation and QP certification.
QP Pro Services holds MIA-2176 H and MIA-2176 IMP, issued by FAMHP / AFMPS for human medicinal products and investigational medicinal products. Eligible customer products can be added to the authorised scope once the quality, product and partner framework is documented.
- MIA-2176 H for human medicinal products
- MIA-2176 IMP for investigational medicinal products
- Belgian authorisation issued by FAMHP / AFMPS
- Fiscal and/or physical importation through Belgium
- EU QP batch certification and release evidence review
- RP/GDP, recall, authority and annual QP/RP review interfaces
1. Scope of Services
What can be covered under the MIA framework?
The exact scope depends on the product type, import route, target markets, storage model and documentation readiness. QP Pro Services provides the controlled QP/RP operating framework for the outsourced activities agreed in the QTA and QP-to-QP Agreement.
GMDP-compliant QMS support for the activities performed under the QP Pro Services MIA.
- SOP templates adapted to customer-specific requirements.
- Controlled procedures to operate as an extension of the customer organisation.
- eQMS onboarding, training records and documented quality responsibilities.
EU QP batch certification for products covered by the MIA.
- QP declarations where applicable.
- Primary QP assignment and trained backup QP coverage.
- Review of the release evidence defined in the quality agreement.
RP/GDP activities where distribution responsibilities apply.
- Administrative release after EU QP certification confirmation.
- GDP-compliant 3PL storage before market placement.
- Transport incidents, temperature excursions, returns and transport vendor approval.
QP oversight of the qualification status needed for the agreed route.
- Supplier qualification and audit report review.
- Formal supplier approval and QP-to-QP agreements.
- Maintenance of supplier and customer qualification status.
Operational support for quality events that may require QP/RP involvement.
- Participation in recalls and mock recalls.
- Shortage, Rapid Alert and authority platform notifications where applicable.
- Support for complaints, quality defects and ADR/PV reporting interfaces.
Regulatory interface and periodic quality review for the activities performed under the model.
- Interface with FAMHP / AFMPS and other competent authorities for EU matters.
- UK interface through the QP Pro Services UK QP network where required.
- Annual QP/RP Quality Management Review with the required customer inputs.
02
Service Delivery
Remote QP review, certification, documentation, eQMS and quality oversight, with on-site audits or inspection presence where the activity requires it.
03
MIA Overview & Implementation
Customer products are added to the licence after QTA and QP-to-QP Agreement execution. MIA scope extensions are agreed with FAMHP where required for the product scope.
04
Key Conditions & Notes
QTA and QP-to-QP Agreement are required before activities start. A separate quotation applies if the customer chooses to obtain its own MIA.
// 5. Next Steps
A controlled onboarding path.
The first discussion is used to confirm whether the MIA route is appropriate and what documentation must be ready before operational work starts.
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