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Are you a biopharmaceutical company seeking to access the European market? Switzerland could be the perfect location for your commercial headquarters or regional centers overseeing operations in Europe and EMEA. Its central location, business-friendliness, competitive corporate and personal taxes, and diverse talent pool make it an attractive option. Companies like Merck Serono, Takeda Pharmaceuticals, Biogen or Johnson & Johnson chose to do so. What about you?

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Cost efficiency, resilient supply chains and integrated tax planning

When it comes to maximizing innovativeness or making processes and structures more cost-efficient, Switzerland offers many advantages as a headquarters or location for central functions. The country is home to very high number of international and European Headquarters of large multinational companies. Many of them operate central management and operational functions such as finance, marketing or payroll, research and development, IP management or global supply chain management from here.
Thanks to its strategic location between the Asian, European and US time zones, Switzerland’s excellent  infrastructure and its solutions for managing revenues and risks have made it a leading destination for multinational companies looking to set up supply chain operations.

Most international supply chain management operations in Switzerland integrate tax planning into their design. The main feature of this model is the pooling of revenues from sales, and risks from manufacturing and distribution, into a single entrepreneur entity in Switzerland. This makes it easier to centralize business activities, functions, risks and other important elements into a centralized supply chain management system. In addition, companies benefit from attractive tax rates that have a positive impact on consolidated earnings.

How to obtain marketing authorization in Europe

To properly benefit from the above described  circumstances, we must talk about marketing authorization and regulations for your products.
One of the fundamental prerequisites for obtaining the MA is for a company to have a legal presence in the European Economic Area (EEA) through a member state entity. It is crucial to approach the health authorities in advance of submitting the dossier, as the process can take a considerable amount of time. This allows them to anticipate the submission and potentially expedite the review process.

For a detailed overview, the European Medicines Agency has compiled a comprehensive step by step guide: Obtaining an EU marketing authorisation, step-by-step | European Medicines Agency

Essential Licenses for Manufacturing, Importing, and Distributing Products in the EU and UK

The Manufacturing Importation Authorization (MIA) pertains to the manufacturing and importation of a product into the European Union. Importation from outside the EU is considered a manufacturing step, and obtaining an MIA is a prerequisite for such imports. Complying with Good Manufacturing Processes (GMP) is essential, including having appropriate facilities, a qualified person overseeing the license, and a quality management system. Timeliness is also critical, with the authorities requiring a minimum of 90 days, although the process may take up to 9 months. Therefore, it is necessary to prepare well in advance.

For distribution, the Wholesale Distribution Authorization (WDA) is required. This authorization follows a similar approach to the MIA with regard to storage, transport, and distribution. The timing of the WDA process is also comparable to that of the MIA. Good distribution practice (GDP) compliance is mandatory and follows the same regulations as the MIA.

Finally, Medicinal Brokerage (MB) licenses enable drug sales support in countries where the drug is not being sold. Partners can purchase and sell drugs without procurement, supply, or possession of the medication. This process is faster and more straightforward, but it requires a permanent address in a member state and adherence to GDP guidelines.

The whole process from lab to patient is described by the European Medicines Agency (EMA): 

Regulations of medical devices in Europe

In contrast to pharmaceuticals, medical devices in Europe are not regulated centrally by the EU. Instead, they are subject to international standards on medical devices, with approval outsourced to a privately held company known as a Notified Body. Once the device has been approved and labeled with a CE mark, it may be sold. In the UK, there is now a separate label known as the UKCA.
Switzerland has traditionally followed the CE label, but after unsuccessful negotiations with the EU, it is now an inbound country only. This means that Switzerland may receive products with the CE label, but they must be received by an affiliate in the EU. Considering the current political situation between Switzerland and the European Union (EU), Swiss medtech companies (third country status) are further challenged with the implementation of the Medical Device Regulation (MDR). Swiss Medtech – the association of Swiss medical technology offers guidance in their MDR-Portal (MDR Portal | Swiss Medtech (swiss-medtech.ch))

The role of marketing authorization and wholesale distribution authorization

Marketing Authorization (MA) used to be a national procedure, but it has now been centralized by the European Medicines Agency (EMA). The EMA assigns a national authority (rapporteur) and a second one (co-rapporteur), and once MA has been granted, the product may be marketed EEA. MA is linked to Manufacturing Importation Authorization (MIA), as MA needs to refer to at least one MIA holder as the supplier of the product. Wholesale Distribution Authorization (WDA) only allows the trading of finished medicinal products. For medical technology, the CE label is the reference for all other countries.

Understanding Switzerland's Unique Position in European Medical Regulations

The main jurisdiction for European Countries is the EU GMP Regulation, which has a framework in place that is renewed periodically, with regulations becoming stricter each year. While there are still differences from country to country, efforts are being made to standardize regulations across the board.

Switzerland is another jurisdiction and has a mutual recognition agreement with the EU and the US, following EU guidelines. The European Economic Area (EEA) also follows EU guidelines.

Switzerland is aligned with EU Good Manufacturing Practices guidelines and, while it is not part of the EU, it is integrated and can be used as a reference country to other countries outside of Europe.

While in general, Swiss regulations follow EU regulations, there is a licence type that does not exist in the EU: Trade Abroad. It is one of the licence types with the lowest level of regulations in Europe. What sets Switzerland further apart is the ease of dealing with the national competent authority, Swissmedic. They are considered to be one of the more flexible and company-friendly authorities in Europe.

Selling into Europe: learn more about the three options of a Swiss entity

There are three ways to sell from Switzerland into the EU:

  • The first is for Switzerland to sell into the EU, with the product imported and released for the EU but owned by a Swiss entity.
  • The second option is for Switzerland to sell into parts of the EU, with the product imported and released for the EU but owned by a Swiss entity and forwarded through an EU entity that allows direct purchasing from Switzerland.
  • The third option is for Switzerland to import and release the product, with it being forwarded into EU countries, with MIAs. This option is more complicated, as MIAs are required for every country.

Switzerland's Advantage in Medical Device Manufacturing for EU Export

For medical devices, the process is simpler. The product is manufactured in Switzerland and forwarded into EU countries with a CE label holder in the EU. Products can be imported freely with the label. Also, you can sell it with the label “Swiss Made”, which stands for very high quality and – as studies have shown – can represent as much as 20% of the sale price compared to comparable goods from other origins.

Do you want to know more?

Check out our factsheets for background information and circle back to our homebase.
Or get in touch with us – even if are just starting to think about expanding your business internationally. We are happy to help.



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