Parallel import supply, from Indian WHO-GMP origin to EU member-state importers.
EU parallel-import licence holders source finished-dose pharmaceutical product from regulated-market manufacturing origins where price differentials between member states make the parallel-import economics work. M Care is the manufacturer-side partner sourcing from Indian WHO-GMP facilities for EU parallel-import operations under Article 28 of Directive 2001/83/EC, with EU-GMP capable manufacturing partners and Qualified-Person release pathways arranged by the destination QP.
Article 28. National parallel-import authorisation. EU single market.
Parallel import in the EU is the practice of importing a medicinal product from one member state where it is authorised, into another member state where it is also authorised, by a parallel-import licence holder rather than the original marketing authorisation holder. The legal basis is Article 28 of Directive 2001/83/EC and the relevant national parallel-import authorisation (in Germany via BfArM, in France via ANSM, in the Netherlands via CBG-MEB, etc.). The parallel importer re-packages and re-labels for the destination market — typically with the destination-language SmPC and patient information leaflet.
Who the route serves
EU parallel-import licence holders running an active parallel-import desk alongside their primary wholesale operation. Specialist parallel-import re-packagers serving the German, French, Dutch and Italian price-differential lanes. EU wholesalers (PHOENIX, Sanacorp, NOWEDA, GEHE, Cardinal Health) holding parallel-import sub-licences.
Where we sit in it
Manufacturer-side. We are not the EU parallel-import licence holder and we do not hold a Wholesale Distribution Authorisation (WDA) in any EU member state. We are the Indian WHO-GMP facility's commercial and regulatory arm, supplying finished-dose product to the destination parallel-import licence holder for re-packaging and re-labelling under that licence.
What the importer gets
Finished-dose product from an Indian WHO-GMP and EU-GMP capable manufacturing partner, with the manufacturer-side QP release documentation pre-built so the destination QP can issue the EU release certificate efficiently. EU-zone batch numbering convention applied at dispatch, pharmacovigilance routing established before first carton.
Why an EU parallel-import desk phones us.
Source-side price differential
Where the same molecule's commercial price varies meaningfully across EU member states, parallel-import economics work. An Indian-manufactured generic equivalent — sourced under EU-GMP partner conditions — typically lands at a price point that beats any intra-EU parallel route, with the regulatory framework of an authorised parallel-import licence holder making the import legal and dispensable.
Stable multi-quarter supply
EU parallel importers operate on quarterly or annual contracts with destination wholesalers. They need supply continuity, not opportunistic batches. M Care arranges multi-quarter standing-order campaigns from the manufacturing partner, with batch-by-batch QP release coordination and stability data harmonised to the contract window.
Re-packaging support at-source
Where the destination market requires destination-language packaging or specific blister formats (German 30-pack, French boxed-30 etc.), at-source re-packaging at an EU-GMP manufacturing partner reduces destination-side handling and accelerates the time-to-pharmacy. M Care coordinates with the manufacturing partner's secondary packaging line.
Stability data for parallel-import dossier
An EU parallel-import authorisation requires the parallel importer to file a dossier referencing the original marketing authorisation. The Indian manufacturer-side documentation (CTD Module 3 stability, manufacturing-site GMP, BE reference) supports the parallel importer's dossier — at the EU-zone temperature-stability profile required by EMA convention.
Every document the destination QP and parallel-import authority asks for.
Prepared at the Indian end and cross-checked before dispatch. EU-GMP capable, QP-release ready, harmonised to the destination member state's parallel-import authorisation requirements.
QP audit pack
Manufacturer-side documents the destination Qualified Person needs to issue the EU release certificate: manufacturing licence, WHO-GMP and (where applicable) EU-GMP certificate, manufacturing batch records, dispatch QA sign-off, packaging records.
EU-zone stability data
Stability data harmonised to the EU temperature-zone profile (Zone II) required by EMA convention for parallel-import dossiers. Where the original Indian-domestic registration uses Zone IVb, bridging stability data is filed against the destination authorisation.
Bioequivalence / reference data
Where the parallel import requires bioequivalence to an EU reference product, the BE study report referenced to the original innovator brand. Required by destination-state parallel-import authorisations for non-innovator-sourced parallel imports.
EU-zone batch numbering
EU-zone batch numbering applied at dispatch, distinct from the Indian-domestic batch numbering, so the destination wholesale chain and pharmacovigilance routing track the parallel-imported batch separately.
Destination-language SmPC and PIL
Where the parallel importer arranges destination-language SmPC and patient information leaflet, we coordinate the at-source translation review and the manufacturing partner's secondary packaging line for destination-language carton printing.
Pharmacovigilance bridging
Pharmacovigilance routing established before first carton — ICH E2D ADR routing back to the manufacturing partner's QA team, with the destination parallel importer holding local PV responsibility under the parallel-import authorisation.
Molecule · destination member state · annual volume · QP partner. One working day.
- Send the parallel-import specifics. Molecule (INN), strength, dosage form, destination EU member state, annual volume, destination-language packaging requirement, the destination QP partner (or QP-on-shelf via outsourced QP arrangement), and the target start-of-supply date.
- Manufacturer match and EU-GMP confirmation. We confirm the Indian manufacturing partner whose facility holds the EU-GMP capability the destination QP can release against, batch availability, expiry, BE reference data on file, and a landed price to the destination importer's nominated EU warehouse.
- QP audit pack. Manufacturing licence, WHO-GMP and EU-GMP certificates, batch records, packaging records, dispatch QA sign-off. Shared electronically for the destination QP to review before issuing the EU release certificate.
- Re-packaging and EU-zone batch numbering. At-source re-packaging at the manufacturing partner's secondary packaging line where destination-language packaging is required. EU-zone batch numbering applied at dispatch. Cold-chain validation where the molecule requires it.
- QP release and ongoing pharmacovigilance. Destination QP issues the EU release certificate. Consignment moves into the destination parallel-import licence holder's distribution chain. Pharmacovigilance routing maintained for the consignment's shelf life, with ICH E2D ADR routing back to the manufacturing partner's QA team.
Parallel import supply — the specifics.
Are you a registered EU parallel importer?
No. We are the Indian manufacturer-side partner. The destination importer must hold the EU member-state's parallel-import authorisation and a Wholesale Distribution Authorisation under Directive 2001/83/EC. We supply product and manufacturer-side documentation; the parallel importer holds the destination regulatory authorisation.
Which EU member states have you supported?
Active manufacturer-side supply into Germany, France, the Netherlands, Belgium, Italy, and (pre-Brexit) the UK. Coverage extends to other EU member states where the parallel importer holds the authorisation; the manufacturing-side workflow is broadly identical across member states.
Do you supply EU-GMP certified manufacturing?
We supply from Indian WHO-GMP and EU-GMP capable manufacturing partners. Several of our partner facilities hold current EU-GMP certificates issued by EU member-state competent authorities (typically following EU member state inspection). Specifics confirmed at quotation against the requested molecule's manufacturing partner.
How do you handle EU-zone stability data?
The Indian manufacturing partner's stability data is harmonised to the EU temperature-zone profile (Zone II) required for parallel-import dossier filing. Where the original Indian-domestic registration was generated against Zone IVb, bridging stability data is filed against the destination parallel-import authorisation.
Can you arrange destination-language re-packaging?
Yes — at-source re-packaging and destination-language SmPC / PIL printing at the manufacturing partner's secondary packaging line. Translation reviewed by destination-side regulatory affairs; carton printing on validated packaging line. Reduces destination-side handling time.
What is the typical contract duration?
EU parallel-import contracts typically run 12-24 months with quarterly batch-by-batch dispatch. We arrange standing-order campaigns at the manufacturing partner's site, with batch-by-batch QP release coordination.
How does pharmacovigilance work for parallel-imported product?
Pharmacovigilance routing is established before first carton. The destination parallel importer holds local PV responsibility under the parallel-import authorisation. ADR reports route back through the destination importer's PV system to the manufacturing partner's QA team via M Care, in ICH E2D format.
Is parallel import the same as named-patient or Specials supply?
No. Parallel import is supply of an EU-authorised medicinal product from one member state to another, by a parallel-import licence holder, under Article 28. Named-patient or Specials supply is supply of an unlicensed medicinal product to a specific patient, under a different regulatory route (in the UK, Regulation 167; in the EU, the destination state's compassionate-use or hospital-exemption pathway). M Care supplies into both routes — they are separate workflows.
An EU parallel-import desk, a price differential, an EU-GMP capable manufacturing partner. That's the conversation.
Molecule, destination member state, annual volume, QP partner. We'll have a manufacturer-side answer inside one working day.