REGULATED CROSS-BORDER CONTEXT

Know what a medicine match really means.

Medimapper can identify related medicine records, presentations and markets. Whether a product may be imported, distributed, marketed or supplied is a separate assessment. That assessment is specific to the product, the parties and the jurisdictions.

DATA ALIGNMENT IS NOT TRADE PERMISSION

Comparable products are the start of the investigation.

01

Data match

Available product attributes align at a stated Medimapper match level.

02

Possible pathway

A regulatory or commercial route may exist for the product, parties and jurisdictions.

03

External verification

Qualified specialists and authorities assess the specific activity, responsibilities and evidence.

THINK IN PATHWAYS, NOT SIMPLE TRADE ZONES

The applicable route depends on the product and jurisdictions.

Illustration of the regulatory boundary: a comparable product on one side, the separate regulatory assessment that governs cross-border movement on the other.
Parallel distribution in the European Union

For a centrally authorised medicine, distribution between EU Member States can fall under the EU parallel-distribution framework. Applicable notification, product, packaging, language, pharmacovigilance and distribution requirements still apply.

Parallel import of nationally authorised medicines

A destination-country authority generally assesses whether the imported product is sufficiently similar to the reference product and whether national requirements are met.

Imports from outside the EU and EEA

Third-country imports can require appropriate authorisations, quality oversight, GMP compliance, batch certification or testing and a valid market route.

Mutual-recognition agreements

These agreements can reduce duplicated regulatory work in covered areas. They are not blanket product or market authorisations.

WHAT MEDIMAPPER DOES

Market and product intelligence with a clear boundary.

Medimapper helps you

  • Compare national product records and presentations
  • Identify related products in selected source data
  • Review local and normalised attributes
  • Analyse product presence and national assortments
  • Keep source links and known data limitations visible

Medimapper does not

  • List medicines for sale or invite bids
  • Accept orders, payments or inventory transactions
  • Broker or execute medicine transactions
  • Decide clinical or regulatory equivalence
  • Replace quality, regulatory, legal or commercial due diligence

REGULATED PARTICIPANTS

The product and the parties both matter.

What has to be verified per party.

  • Marketing authorisation and the applicable route
  • Manufacturing, import and wholesale-distribution authorisations
  • GMP and GDP status
  • Packaging, labelling, language and serialisation requirements
  • Product-specific, intellectual-property and pharmacovigilance responsibilities

FROM DATA SIGNAL TO REGULATED DECISION

Use better data at the beginning of the process.

  1. 01

    Identify

    Find a related substance, presentation, pack or commercial item.

  2. 02

    Verify the data

    Review local records, normalised attributes, identifiers and source links.

  3. 03

    Assess the pathway

    Determine the applicable requirements with qualified specialists and authorities.

  4. 04

    Verify the parties

    Confirm licences, roles, responsibilities and applicable quality systems.

  5. 05

    Continue outside Medimapper

    Negotiation, contracts, orders, payment and supply activity take place outside the platform.

START WITH PRODUCT COMPARISON

Build a source-linked shortlist before beginning separate due diligence.