31.7.2010

EN

Official Journal of the European Union

C 209/11

(Case C-185/10)

()

2010/C 209/16

Language of the case: Polish

Parties

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

Defendant: Republic of Poland

Form of order sought

—declare that, by adopting and maintaining in force Article 4 of the Usatawa ‘Prawo farmaceutyczne’ (Law on Medicinal Products) of 6 September 2001 as amended by the Law of 30 March 2007 (Dz. U. No 75, heading 492), in so far as that article allows medicinal products imported from abroad having the same active substances, the same dosage and the same form as medicinal products which have obtained marketing authorisation in Poland to be placed on the market in Poland without authorisation issued there if the price of the former medicinal products is competitive in relation to the price of the latter, 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; (<a id="ntc1-C_2010209EN.01001102-E0001" href="#ntr1-C_2010209EN.01001102-E0001"> (1)</a>

—order the Republic of Poland to pay the costs.

Pleas in law and main arguments

The adoption and application by the Republic of Poland of Article 4(1) and (3a) of the Law on Medicinal Products make it possible for medicinal products to be marketed in Poland when they do not possess a marketing authorisation in Poland issued by the competent national authorities, a situation which is contrary to Article 6(1) of Directive 2001/83.

In the applicant’s submission, the Polish provision is not covered by Article 5(1) and Article 126a of Directive 2001/83, which provide for exceptions to the general requirement contained in Article 6(1) of that directive that medicinal products must have a national authorisation.

Above all, Article 4(3a) of the Law on Medicinal Products, according to which the condition for allowing imported medicinal products is their ‘competitive price’ compared with the price of medicinal products already allowed on the national market, is based exclusively on an economic criterion. A criterion of that kind cannot, however, justify an exception to Article 6(1) of Directive 2001/83. Furthermore, the Polish provision concerns medicinal products with the same active substance, form and dosage as medicinal products already permitted on the national market, and it is therefore not possible to consider them to be unavailable on the national market, a situation which might justify the need for targeted import on the basis of Article 5(1) of the directive.

(<span class="super">1</span>) OJ 2001 L 311, p. 67.