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How is parallel trade regulated?

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Article 35 of the Treaty on the Functioning of the European Union (TFEU) states that quantitative restrictions on exports between Member States and all measures having equivalent effect are prohibited. The Court of Justice of the European Union interprets "measures having equivalent effect" as all those introduced by a Member State that directly or indirectly hinder, in fact or potentially, trade within the EU. Art. 36 of the TFEU introduces an exception to the prohibition of Art. 35, but only when it comes to protecting the health and life of people with clear and precise argumentation.

There is no evidence that parallel trade leads to a deficit in the exporting country. Manufacturers and wholesalers are obliged, under EU law, to ensure the continuity of supply of medicinal products at any time. Wholesalers also have "public service obligations" under national law and their business codes, under which they are obliged to ensure sufficient availability for timely delivery of medicines to local pharmacies before undertaking export sales steps.