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EU / MIA importation

A Belgian MIA framework for clinical and commercial products, with QP certification and RP/GDP support.

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// What we do

EU / MIA importation services

Importation and certification

  • MIA for clinical and commercial products
  • EU batch certification and importation
  • UK QP certification through partner QPs

Partners and distribution

  • Importer of Record (IOR) via broker partners
  • RP and GDP distribution support
  • EU testing, serialisation and distribution partners

Regulatory support

  • End-to-end eCTD review, improvement, publishing and submission
  • Change management
  • QPPV and Information Officer on behalf of the MAH
// Our expertise

EU / MIA scope

MIA and certification route

MIA and certification route

  • Belgian MIA-2176 H and MIA-2176 IMP for agreed product activities
  • Clinical and commercial products; fiscal and physical importation
  • Product scope review and any required authority extension
  • EU QP certification and declarations; UK certification through partner QPs
  • A separate scope applies when the customer obtains its own MIA
Quality agreements and eQMS

Quality agreements and eQMS

  • QTA and QP-to-QP agreements before activities begin
  • Primary QP, trained backup and applicable RP/GDP roles
  • Customer-specific procedures, SOP templates and training
  • Controlled records, access, qualification evidence and onboarding plan
Batch release and distribution

Batch release and distribution

  • Batch documentation, deviations, changes and transport evidence
  • QP certification and RP administrative-release interfaces
  • Customer and supplier qualification, audit review and formal approval
  • Transport vendor approval, excursions, incidents and returns
Testing and supply partners

Testing and supply partners

  • EU testing and serialisation partners
  • Storage and distribution interfaces
  • Importer of Record via broker partners
  • Manufacturer and MAH coordination; fiscal and physical flows
  • Partner qualification, agreements and readiness before shipment
Regulatory and safety interfaces

Regulatory and safety interfaces

  • eCTD review, improvement, publishing and submission
  • Regulatory change management and follow-up records
  • QPPV and Information Officer support on behalf of the MAH
  • ADR/PV interfaces, complaints and quality defects
  • Belgium / Benelux artwork review
Recalls and quality review

Recalls and quality review

  • Recalls, mock recalls and quality-defect assessment
  • Shortage, stock-out, Rapid Alert and PharmaStatus notifications
  • FAMHP/AFMPS liaison, inspections and authority requests
  • Self-inspections and annual QP/RP Quality Management Review
Onboarding and delivery

Onboarding and delivery

  • RFI: products, markets, partners, route and timeline
  • Scope call, documentation readiness and MIA extension needs
  • NDA, QTA, QP-to-QP, qualification and initial training
  • Secure remote documentation, certification and eQMS work
  • On-site audits and inspections; schedule agreed against readiness
Importation in practice

The essentials of your EU importation route

MIA framework

Clinical and commercial product scope, with qualification and onboarding under the agreed Belgian MIA framework.

Quality agreements

QTA and QP-to-QP agreements define the activities and interfaces between the manufacturer, MAH, importer and partners.

QP certification

Batch documentation and supporting evidence are reviewed for QP certification and the agreed release pathway.

GDP distribution

RP support connects partner qualification, storage and transport controls, incident management and distribution oversight.

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