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Parallel Import and Parallel Distribution in the Pharmaceutical Industry: What You Need to Know

In Belgium, these practices are regulated under the Royal Decree of April 19, 2001 regarding parallel import of medicines for human use and parallel distribution of medicines for human and veterinary use. which sets out the legal framework for the parallel import of human-use medicines and the parallel distribution of medicines for both human and veterinary use.

What is Parallel Import?

According to the Federal Agency for Medicines and Health Products (FAMHP), this means a pharmaceutical company (not the original marketing authorization holder) brings in a medicine that’s therapeutically equivalent to a product already on the Belgian market — known as the reference medicine.

And no, “import” in this context does not mean the medicine is coming from the other side of the world. It actually refers to trade within the European Union (EU) or European Economic Area (EEA). Furthermore, it is called « parallel » because this trade occurs outside the distribution network established by manufacturers or original distributors.

To legally parallel import a medicine into Belgium, the importer must meet a few key conditions:

1. The imported medicine must be therapeutically equivalent to its Belgian reference medicine and have the same pharmaceutical form.
2. The importer must obtain a parallel import authorization from the FAMHP.
3. Any repackaging or relabelling must meet Belgian regulatory standards to ensure safety and transparency for patients.
4. The name or trade name, as well as the address or registered office of the license holder, need to be clearly visible. The license number must be included, along with “imported by…” (in Belgium: in the three national languages (Dutch, French, German)) followed by the name of the importer.

So, what about Parallel Distribution?

Parallel distribution is slightly different. You might have heard the term parallel distribution tossed around in the pharmaceutical world, but what does it actually mean? Parallel distribution happens when a centrally authorised medicine is moved from one EU country to another by a company other than the one that originally got the green light to market it.

Sounds a bit complicated? That’s where the European Medicines Agency (EMA) steps in. Since 20 May 2004, under EU Regulation (EC) No 726/2004, companies must notify the EMA before they start parallel distributing centrally authorised medicines. Their job is to make sure these parallel-distributed products still meet all the strict rules laid out in EU legislation as well as the original conditions of the medicine’s marketing authorisation. In other words, just because a different company is distributing the medicine doesn’t mean the standards can slip. Curious to dig deeper? Check out the EMA website and FAQ on parallel distribution (Parallel distribution | European Medicines Agency (EMA)) for more insights into how it all works.

Final Thoughts

While parallel import and distribution may sound like industry jargon, they’re actually important tools in keeping medicines both affordable and accessible. They’re tightly regulated to ensure safety, quality and transparency.

However, there are challenges associated with parallel trade. The increased complexity in the supply chain can make it harder for originators to plan manufacturing forecasts. Additionally, the repackaging required to meet national language requirements introduces a higher risk to the quality and traceability of the products. It’s also crucial to consider the Intellectual Property rights of the original Marketing Authorization Holder.

As the healthcare landscape continues to evolve, the challenge will be finding the right balance: encouraging market efficiency while maintaining the high standards that protect patients.

By Kelsey Frederickx