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02-02-2022 | 10:30 - 11:00 CET

30-minute online training on what you should know about processes and procedures relating to EU exports to Japan. It covers trade and administrative rules and regulations relevant to EU businesses which are new to exporting as well as those which carry out regular, on-going businesses with Japan.

Focus is given to small and medium sized EU enterprises (SMEs) and to those sectors which offer growing opportunities to EU exports to Japan, i.e., food and health sectors.

What Licenses are Required for EU Pharmaceuticals and Medical Devices in Japan?

When selling pharmaceutical and medical device products to Japan, EU companies may consider 3 options, namely use of a Japanese distributor, direct sales to end customers, or commercial licensing to a Japanese company.

Major administrative licences needed for manufacture, importation and marketing of pharmaceutical products and medical devices in Japan include (1) marketing business licence for distributors, (2) manufacturing business licence for manufacturers in Japan, (3) accreditation for foreign manufacturers who supply products to Japan and (4) marketing authorization for each product.

In case of extremely urgent cases, however, Japan may exempt some rules on licensing as it was seen recently on certain treatments related to Covid-19.  As for medical devices, while suppliers are not required to have specific certifications or licenses to sell products to medical device manufacturers, there are some Japan-specific standards, such as Japanese Industrial Standard (JIS), that EU suppliers need to comply with.

The webinar targets EU small- and medium-sized enterprises (SMEs)

In 30 minutes from your desk, discover:

  • Marketing Licensing
  • Licensing for Manufacturing
  • Accreditation for Foreign Manufacturing
  • Particulars for Pharmaceuticals
  • Particulars for Medical Devices

Programme:

  • Introduction
  • Expert’s presentation
  • Q&A Session

Registration deadline: 1 February 2022

Speaker: Chieko Nakabayashi worked at the United Nations Industrial Development (UNIDO) in Vienna, the Food and Agriculture Organization of the United Nations (FAO) in Rome, and Japanese bilateral ODA agencies.  She is currently a professor and a consultant, specialized in cross-border business development in industrial and agricultural sectors and cross-cultural business communications. 
ModeratorPauline Laloux, Business Support Coordinator, EU-Japan Centre
Organiser: EU-Japan Centre for Industrial Cooperation - Brussels Office