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.