How to Obtain a Parallel Import Licence (Step-by-Step Guide)

A Parallel Import License (PIL) is a license that permits a distributor or wholesaler to bring a branded pharmaceutical from abroad to the country where he sells it and thus legally. It is necessary that the product is the same as the original drug already approved in the home country. This is a license that most EU countries and the UK require. The downside is that the procedure is lengthy, not very clear, and very hard to understand. The following guide tells you the full journey in a simple and easy-to-follow manner.

What Is a Parallel Import Licence?

A PIL gives you the right to bring in a drug from a foreign country, even if the maker did not supply it to you directly.

You are allowed to do so if:

• Your market has already given its approval to the medicine
• The active ingredient and strength are the same as the local version
• Local packaging and safety standards will be followed
• Quality and artwork checks need to be passed

With the PIL, you can import, repackage, relabel and sell the drug just as in the local pack. (Related: Parallel Import of Medicines: Complete Guide for Procurement Teams)

When Do You Need a Parallel Import Licence?

A PIL is required if you intend to:

• Import a branded drug for resale
• Repack or re-label the product
• Distribute the product in pharmacies, hospitals, or through tenders
• Function as a legal importer of packs for sale

If you are only importing for a named patient or for personal use, this license is not necessary.
 

Things You Need to Prepare Before Submitting Application

Before you start from scratch, get ready with some essentials. This will make the process quicker and smoother.

1. Proof of Product Equivalence

The drug to be imported has to be the same as the one supplied in your market regarding the following aspects:

• Active ingredient
• Strength
• Dosage form
• Route of administration
• Therapeutic use

2. Source Country Details

You should be aware of the origin of the product. It is usually an EU country with low prices.

3. Repackaging or Relabelling Plan

Regulators usually ask for:

• New outer packaging
• Leaflet in the local language
• Serialisation
• Tamper-evident seals

4. Pharmacovigilance System

You will need a safety event reporting plan that involves the product you have imported.

5. Good Distribution Practice (GDP) Compliance

Your storage and transport partners have to observe the strictest GDP rules.

Step-by-Step Process to Obtain a Parallel Import Licence

Read on for the full but easy-to-understand PIL process.

Step 1 — Prepare the Product Dossier

This includes:

• Data regarding the source product
• Documental proof of equivalence
• Sharing the safety profile
• Providing stability information
• Packaging and leaflet proposal

Keep the dossier simple and easy to follow. It really helps to quicken the review process.

Step 2 — Create the Artwork and Mock-Ups

It is necessary to show drafts of the designs for:

• Outer box
• Inner blister label (if any)
• Leaflet in the local language
• Serialisation code area
• Anti-tamper seal area

The design has to conform perfectly to local regulations. Even a very tiny mistake—like the omission of a symbol—can cause the approval process to be prolonged.

Step 3 — Submit the Application to the National Authority

You are required to lodge your application with the regulatory authority in your country. Case in point:

• UK: MHRA
• Germany: BfArM
• Netherlands: MEB
• Nordics: National Medical Agencies

Your application comprises the dossier, artwork, payment of fee, and cover letter.

Step 4 — Respond to Regulator Queries

Regulatory authorities frequently demand:

• Stronger proof of equivalence
• Explanations concerning the leaflet text
• New artwork
• Recent safety information
• Answer quickly so that you do not suffer from delays.

Respond quickly to avoid delays.

Step 5 — Receive Your Parallel Import Licence

After approval, the regulator will give a license containing:

• PIL number
• Name of the product that has been approved
• Instructions for packaging
• Permissions for supply from the country of origin
• Requirements for safety reporting

You are now able to import and distribute the medicine legally.

Tips for Faster Approval

As a matter of fact, these are simple tips that will enable you to get the approval on your first attempt.

1. Use the Same SmPC as the Local Product

The product information leaflet and local SmPC should be the same in every detail.

2. Keep Repackaging Minimal

Do not make changes to the product that aren't necessary.
Minimal changes = faster approvals.

3. Check Serialisation Rules Early

Each country has its own unique barcode rules.

4. Work with a GDP-Certified Warehouse

Regulatory authorities demand proof of safe preserving and transporting.

5. Avoid Weak Translations

Utilize only licensed medical translators at all times.
 

Common Reasons for Rejection

1. Product Not Equivalent

Even a slight change in strength or excipients may result in unapproval being granted.

2. Poor Artwork Design

Immediately rejection occurs when warnings are missing or symbols are incorrect.

3. Incorrect Leaflet Text

Leaflet must be exactly the same as the local version in terms of words used.

4. Weak Pharmacovigilance Plan

The license will not be granted unless you furnish the tracking and reporting scheme of adverse events.

5. Incomplete Documents

Delay in approval will be a result of missing reports, unclear labels, or wrong pack photos.
 

After You Receive the Licence

The approval is just the very beginning of your work.
What you are required to do next is as follows:

1. Start Repackaging According to Approved Artwork

Let none of the PIL rules be ignored.

2. Use Serialisation Systems

Where it is necessary, upload pack data to the national database.

3. Maintain Full Traceability

For each batch and each sale, keep the records.

4. Report Safety Events

Regulator must be notified of all adverse events.

5. Prepare for Inspections

Your warehouse and packaging site might be visited by the regulators.
 

How a B2B Platform Helps With Parallel Import Licensing

An excellent pharmaceutical sourcing platform or service partner will be able to assist you with:

• Locating suppliers in the EU/UK
• Gathering necessary documents
• Creating artwork and mock-ups
• Complying with GDP requirements
• Monitoring temperature and shipping data
• Minimizing errors during application
• Accelerating the PIL approval timeline

These all make the process quicker, safer, and much more reliable for both distributors and hospitals.
 

Conclusion

If you adhere to a well-defined procedure, the acquisition of a Parallel Import Licence will be simple. The right documents, proper artwork, and a good grasp of local regulations will be needed. With an efficient system in place, you can get approvals quickly and import medicines that are safe, of high quality, and at better prices in your market.

Frequently Asked Questions

Do I need a Parallel Import Licence in every country?

Yes, each country has its own licence.

Can I use the same artwork in many markets?

No, artwork must follow the rules of each country.

Can hospitals apply for a Parallel Import Licence?

Usually only licensed distributors apply.

Is Parallel Import Licence the same as a wholesale licence?

No, you still need a wholesale licence to sell the product.