Parallel Import of Medicines: Complete Guide for Distributors & Hospitals (2025 Edition)

Parallel Import of Medicines: Complete Guide for Distributors & Hospitals (2025 Edition)

Parallel import (PI) has become one of the most vital tools for hospitals, distributors and pharmacies that want to optimise procurement, reduce costs, and secure access to generic medicines. Parallel import is legal and structured in regulated territories such as the EU/EEA and the UK, if all necessary licensing and repackaging requirements are met.

This guide breaks it down into units.

What Is Parallel Import in Pharmaceuticals?

Parallel import (PI) is the exchange of a trademark or brand of medicine from the country where the original manufacturer may purchase or sell it, while this product is legitimately produced, authorised and licensed in the destination market, and complying with national regulatory norms.

Key points:

• Under the principle of free movement of goods between EU/EEA,
• Supported by particular national licensing such as PI licenses in Germany, PLPI in the UK.
• Repackaging/relabelling to meet local packaging requirements, requires repackaging/relabelling.
• Ensures that product traceability is maintained and must abide by the pharmacovigilance and traceability of products.
• PI is a legitimate, regulated channel that is entirely distinct from counterfeit or grey-market activity.
   

Parallel Import's Existence (Regulatory Reasoning)

The parallel import (PI) assists in setting up fair pricing and competition among different international markets. The local rules, reference pricing and agreements within the EU are often the reasons for the price to differ.

The parallel import's intervention leads to:

• The closing of price differentials among nations
• Greater availability of life-saving drugs
• Enhancement of the stability of the supply and competition
• Provision of the needed support

A number of consumers perceive PI as being less expensive than the branded products.

How Parallel Import Functions (Whole Process)

The process of parallel import looks like this:

Step 1 — Identify Price Differences Among EU Countries

Some countries have lower price for medicines:

• Greece
• Spain
• Portugal
• Eastern Europe

And some are pricier:

• Germany
• Nordic countries
• Netherlands
• UK (after Brexit)

The potential for profit relies on price differentials and the costs of licensing.

Step 2 — Purchase the Product from a Cheap EU Country

A wholesaler with a license buys the original product from the authorized distribution in the exporting country.

The main requirements are:

• Obey the Good Distribution Practices (GDP)
• Guarantee the complete batch traceability
• Send the product under the approved temperature control

Step 3 — Repack or Relabel (If Necessary)

Different countries have different rules regarding repackaging. You may have to do the following:

• Apply new outer packaging
• Have the leaflet translated into the local language
• Implement serialization (2D barcode, GTIN, NTIN)
• Use anti-tampering device (if required)

Some countries permit "stickering," others necessitate a complete redesign.

Step 4 — Submit for a Parallel Import License (PIL)

Most of the EU nation-states necessitate a PIL (Parallel Import Licence) to deliver the product to the market.

Examples:

• Germany: BfArM PI Approval
• Netherlands: MEB PI Listing
• UK: MHRA Parallel Import Licence (PLPI)
• Spain/Italy: National agencies demand prior authorisation

The approval confirms that the imported product has the same active ingredient, strength, and therapeutic effect as the version that was locally approved.

5th Step — Marketing to Hospitals, Pharmacies, and Distributors

Different from non-licensed PI products, those with a license enter the market at a lower price; thus procurement departments are able to save money on more expensive therapies while still being compliant both from the regulatory and quality sides.
 

Parallel Importation Advantages for Hospitals and Wholesalers

1. Considerable Cost Reductions

PI may price from 5–40% less compared to the branded price depending on the market and the molecule.

2. Availability of Brand-name Drugs during Periods of Stock-out

PI is the best alternative when the pack is not available in the local market.

3. Enhanced Procurement Flexibility

Hospitals may broaden their procurement procedures so that they do not rely exclusively on one supplier.

4. Quality & Safety Assurance

The product is manufactured by the innovation company, which means quality is absolutely assured.

5. Traceability & Regulatory Oversight

This not only guarantees that PI is safe and transparent but also that it is monitored and serialized by European/UK regulators.

Regulatory Requirements Evaluation for Main Markets

1. European Union (EU/EEA)

PI is allowable under the free movement of goods clause, subject to:

• The products being identical in both countries.
• The licensing authority approval is obtained for an PI licence.
• Repackaging in accordance with the Directive 2001/83/EC is compatible with Directive 2001/83/EC.
• The safety features comply with FMD (serialization and anti-tampering).

Every EU country has its unique PI model, timelines, and artwork regulations.

2. Germany (BfArM)

Germany is Europe's biggest PI market.

The following documents are required:

• Proof of product identity
• Mock-ups of packaging
• Parallel Import Licence (PIL)
• Pharmacovigilance system
• Approval of artwork
• Distribution in compliance with GDP

3. Netherlands (MEB)

Products obtained through PI must correspond to the SmPC of the Dutch reference product. The repackaging rules are very strict, and the mock-ups have to get pre-approval first.

4. UK (Post-Brexit, MHRA)

The UK has a separate route for obtaining Parallel Import Licences (PLPI) for importation of specific products only.

The following requirements have to be fulfilled:

• Proof of equivalence
• Approval of artwork/leaflet
• Printing of PI Product Licence number on the pack
• Compliance with MHRA safety and quality standards

Certain EU PI suppliers have been affected by Brexit and cannot supply to the UK unless special arrangements are made.

5. Middle East & Asia

Most non-EU markets restrict PI; however, some regions will allow regulated imports through:

• Tender-based sourcing
• Exceptional approvals
• Shortage-based imports
• Named-patient routes

It is advisable to constantly verify national laws as PI is not universally authorized like in the EU.

Licensing & Repackaging Rules

1. Parallel Import Licence (PIL)

A PIL guarantees that:

• This product is identical in active ingredient, shape, route, strength.
• This is a valid transaction.
• The source of the product is legitimate.
• Quality and safety are preserved after repackaging.
• Labeling conforms to local requirements.

2. Mock-Ups & Artwork Approval

Prior to sales companies are required to provide:

• Design of the outer box
• Artworks for blisters/labels
• Translations of the leaflet
• Data on serialization

3. Repackaging Categories

Depending on the country:

• Full Repackaging — entirely new box + leaflet
• Over-Sticking — applying labels in the local language
• Relabelling — changes in part
• No Repackaging — if packs already comply with requirements (very rare)

The process of repackaging must not adversely affect the product’s stability or safety.

Quality, Safety & GDP Compliance

In order to guarantee the quality of their products, PI wholesalers must abide by the following rules:

• Good Distribution Practices (GDP)
• Temperature-controlled handling (2–8°C, -20°C, etc.)
• Batch traceability
• Serialisation scanning
• Pharmacovigilance reporting
• Secure storage and anti-theft controls

Besides that, cold-chain disruptions or poor warehousing are the major warning signs for regulators.

When Parallel Import Is Not Permitted

There are times when parallel import is specifically not allowed and those instances include:

1. The destination country does not allow the product

For example, local approval is required for the reference product if it has already been produced.

2. Biologics that are complex and composed of different formulations

Regulatory rejection is sometimes being caused by just a tiny change in excipients.

3. Very Strict IP prohibitions or injunctions

Currently, some manufacturers depend on the court's protection or litigation to stay in the market.

4. Concerns about quality and safety

As a consequence, regulators may block products that come with inconsistent packaging or have serialization issues.

5. Substances under control

Narcotics and psychotropics require import permits specifically for non-PIs.

Common Risks & How to Reduce Them

1. Packaging/Trademark Conflicts

If manufacturers feel that the application of their trademark is excessive due to repackaging, they might object.
Solution: Follow strict minimum-change regulations.

2. Artwork of Poor Quality

License rejection might be caused by the use of incorrect translations or the lack of warnings.
Solution: Engage certified artwork providers.

3. Serialisation Errors

Market withdrawal can be due to an incorrect GTIN or the failure of tamper-evidence.
Solution: Do validation on each batch before dispatch.

4. Supply Instability

Shortages of exporters might lead to supply halts.
Solution: Create networks for sourcing in multiple countries.

5. Wrong SKUs or packs that are not equivalent

PI gets disqualified for small differences in strength or formulation.
Solution: Always verify equivalence with the local SmPC.

How B2B Pharma Platforms Add Value to Parallel Import Activity

A professional sourcing platform can dramatically reduce risk and effort for buyers.

1. Verified EU/UK Supplier Network

Ensures only authorised & GDP-certified partners participate.

2. Real-Time Stock Availability

Helps hospitals secure urgent products during shortages.

3. Documentation Support

PI licences, repackaging artwork, and compliance checks.

4. Cold-Chain Tracking

Live monitoring for biologics and temperature-sensitive meds.

5. Transparent Pricing

Buyers can compare PI vs innovator pricing instantly.

6. Risk Management & Product Authentication

Serialization + batch verification reduce counterfeit risks.

Conclusion:

In conclusion, parallel import is a useful tool for international buyers. One of the best methods for:

• Cutting expenses
• Ensuring continuous access
• Remaining resilient in the face of shortages
• Keeping up a premium branded supply
• Increasing the flexibility of procurement

PI can be an effective part of a hospital's or distributor's sourcing strategy with the right licensing, compliance, and trustworthy suppliers.

Frequently Asked Questions

FAQs on Parallel Import of Medicines

Is Parallel Import legal?

Yes, in the EU/EEA and UK with proper licensing.

Does PI involve generic medicines?

Usually no — PI is mainly for branded/innovator products.

Is PI the same as grey-market sourcing?

No. PI is fully legal, regulated, documented, and traceable.

Can hospitals directly import via PI?

Typically through licensed distributors, but hospitals may participate in tender-driven procurement.

Do PI products differ clinically from local products?

No — they must be pharmaceutically equivalent.