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Medicines authorised with a summary of the risk management

Parallel import on the other hand concerns only nationally authorised products and is authorised by the national competent authority of the Member State of import based on the similarity to the product distributed in the Member State of destination by the marketing-authorisation holder (hereinafter “MAH”). The material differences approach is similar to the international exhaustion system but prohibits the sale of parallel imports if they are materially different from the goods that the trademark owner has authorized to be put on the market in a given country. What is considered “material” may vary from jurisdiction to jurisdiction. Scope. This Practice Note explains trade mark law on parallel trade. Parallel imports, or ‘grey market’ goods, are genuine goods that are placed on the market by, or with the consent of, the rights holder but are imported for sale into a particular market without the rights holder’s consent.

Parallel import of pharmaceuticals is when original medicine is imported from another EU/EEA country and sold in Denmark on par with the original manufacturer’s Danish packaging. While the medicines sales in the EU have been rapidly growing over the last decade, reaching €189 billion in 2018, the turnover of EU parallel imports has remained stable in the same period around €5.5 billion. In 2018, the sales of parallel imports only represented about 2.9% of the total sales of pharmaceuticals in Europe. Parallel import on the other hand concerns only nationally authorised products and is authorised by the national competent authority of the Member State of import based on the similarity to the product distributed in the Member State of destination by the marketing-authorisation holder (hereinafter “MAH”). The material differences approach is similar to the international exhaustion system but prohibits the sale of parallel imports if they are materially different from the goods that the trademark owner has authorized to be put on the market in a given country.

Consequently, EU law protects and supports parallel imports as a tool for achieving and maintaining a single market. The issue of parallel imports affects various business sectors and Turnover of EU parallel import in billion € Source: IQVIA Share of the total market in % While the medicines sales in the EU has been rapidly growing over the last decade, the parallel import market have remained stable - why the share of parallel imports fell to a record low 2.9% in 2018.

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0 replies 0 retweets 0 likes. Reply. 4 Hays, Thomas, Parallel Importation under European Union Law, London, 2004 (”Hays”), s.

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generally The volume of parallel imports of proprietary medicinal products within the European Union is significant, on account of differences in the prices set by national governments in the health sector. The Commission accepts that parallel trade is lawful based on the principle of the free movement of goods, provided that it does not pose a threat either to public health or to industrial and commercial property. A parallel import is a non- counterfeit product imported from another country without the permission of the intellectual property owner. Parallel imports are often referred to as grey product and are implicated in issues of international trade, and intellectual property.

Parallel import on the other hand concerns only nationally authorised products and is authorised by the national competent authority of the Member State of import based on the similarity to the product distributed in the Member State of destination by the marketing-authorisation holder (hereinafter “MAH”). 2. Parallel import in the European Union is the perfectly legal activity under Art. 28-30 EC of buying goods in a low-price country in order to ship and sell them in a high-price country. The pharmaceutical market in Europe is subject to the subsidiartiy principle of Art. 5 EC Parallel imports of proprietary medicinal products. The volume of parallel imports of proprietary medicinal products within the European Union is significant, on account of differences in the prices set by national governments in the health sector.
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parallel import cases involve trade marks rights, but they can also involve other IPRs. We are all familiar with the types of IPRs and their increasing role in today’s globalizing world, so these issues will not be discussed herein.

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parallelimport är mer att man importera utanför EU utan att fråga om rättighetsinnehavarens tillstånd.