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Parliamentary questions
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10 February 2020
Answer given by Mr Breton
on behalf of the European Commission
Question reference: E-004249/2019

According to the settled jurisprudence of the Court of Justice(1), parallel trade of medicinal products is a lawful form of trade within the internal market, subject to Articles 34 — 36 of the Treaty on the Functioning of the European Union. At the same time, Directive 2001/83/EC on the Community Code relating to medicinal products for human use(2) foresees an obligation of appropriate and continuous supply so that the needs of patients in each Member State can be covered.

The Commission has not received any complaints about the possible incompatibility of Article 129 of the Sozialgesetzbuch (SGB V) with the internal market rules. Currently, the Commission has no indication that this provision would infringe EC law.

Already today, Member States may take measures to prevent or address shortages of medicines, by restricting their free movement from, to and within their territory in order to protect human life and ensure adequate supply of medicinal products on their territory. Such measures need to be justifiable as appropriate, necessary and proportionate to the objectives pursued.

(1)C-104/75 De Peijper,C-201/94 Smith & Nephew, C-94/98 Rhone Poulenc, C-172/00 Ferring, C-15/01 Paranova Lakemedel and Others, C-387/18 Delfarma
(2) OJ L 311, 28.11.2001, p.67
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