Unauthorised foreign drug and EU law

It is contrary to European Union law if, /under Polish law/ foreign medicinal products may be placed on the market are not approved but are cheaper than similar drugs that are already approved. Including through financial reasons the marketing of such products is not justified.

Thus the decision of the Court of the European Union in the present case of an infringement action, which was brought by the Commission of the European Union. The Commission considers that the Polish legislation with Directive 2001/831 is inconsistent. Following the Directive 2001/83, no medicinal product in one Member State only brought into the market if the competent authority of that Member State or the European Medicines Agency a marketing authorization has been granted.

However, a Member State has special needs, may exceptionally provide that this requirement does not apply to medicinal products, which was not advertised good faith. imageThe Court of Justice of the European Union, first of all, that the harmonized procedure for the granting of the marketing authorization allows market access to commercially reasonable and non-discriminatory terms.

In addition, it happens while ensuring the necessary protection of public health. Exceptions must remain and can be exercised only when necessary, taking into account the special needs of the patient. The term “special needs” refers solely for medical reasons justified individual cases, and assumes that the product is required to meet the needs of patients.Consequently, the exception provided for in the Directive concern only for situations in which requires the medical evaluation the health status of their individual patients.

The administration of a drug for which there is no approved on the national market, or the equivalent in that market, is not available.The Court of Justice of the European Union notes that introduce the disputed Polish law is an exception. The Court of the European Union rejects the argument of Poland.


It is according to the importation and marketing of a drug at home, which is less expensive than an equivalent drug present for which has a marketing authorization. They can be justified on financial grounds, as far as importing and marketing were necessary to ensure the financial stability of the national social security system.

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