# C_2012151EN.01000302.xml

| 26.5.2012 | EN | Official Journal of the European Union | C 151/3 |
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26.5.2012

EN

Official Journal of the European Union

C 151/3

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Judgment of the Court (Third Chamber) of 29 March 2012 — European Commission v Republic of Poland

(Case C-185/10) (1)

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(Failure of a Member State to fulfil obligations - Directive 2001/83/EC - Articles 5 and 6 - Proprietary medicinal products - Medicinal products for human use - Marketing authorisation - Legislation of a Member State exempting medicinal products similar to but cheaper than authorised products from marketing authorisation)

2012/C 151/05

Language of the case: Polish

Parties

Parties

Applicant: European Commission (represented by: M. Šimerdová and K. Herrmann, acting as Agents)

Applicant:

Defendant: Republic of Poland (represented by: M. Szpunar, acting as Agent)

Defendant:

Re:

Re:

Failure of a Member State to fulfil obligations — Infringement of Article 6 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67) — Legislation of a Member State permitting medicinal products having a lower price and characteristics similar to authorised products to be marketed in that State without prior authorisation

Operative part of the judgment

Operative part of the judgment

The Court:

| 1. | Declares that, by adopting and maintaining in force Article 4 of the Law on Medicinal Products (Prawo farmaceutyczne) of 6 September 2001, as amended by the Law of 30 March 2007, inasmuch as that statutory provision dispenses with the requirement for a marketing authorisation for medicinal products from abroad which have the same active substances, the same dosage and the same form as those having obtained a marketing authorisation in Poland, on condition that, in particular, the price of those imported medicinal products is competitive in relation to the price of products having obtained such authorisation, the Republic of Poland has failed to fulfil its obligations under Article 6 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007; |
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1.

Declares that, by adopting and maintaining in force Article 4 of the Law on Medicinal Products (Prawo farmaceutyczne) of 6 September 2001, as amended by the Law of 30 March 2007, inasmuch as that statutory provision dispenses with the requirement for a marketing authorisation for medicinal products from abroad which have the same active substances, the same dosage and the same form as those having obtained a marketing authorisation in Poland, on condition that, in particular, the price of those imported medicinal products is competitive in relation to the price of products having obtained such authorisation, the Republic of Poland has failed to fulfil its obligations under Article 6 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007;

| 2. | Orders the Republic of Poland to pay the costs. |
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2.

Orders the Republic of Poland to pay the costs.

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(1)  OJ C 209, 31.7.2010.

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