Judgment_paragraph 19 · The Queen v The Medicines Control Agency, ex parte Smith & Nephew Pharmaceuticals Ltd and Primecrown Ltd v The Medicine Control Agency (C-201/94)

19According to the first and second recitals in the preamble to Directive 65/65, the primary purpose of that directive is to ensure that, when a proprietary medicinal product is marketed, public health is safeguarded by means which cannot hinder the development of the pharmaceutical industry or trade in medicinal products within the Community. To that end, the directive requires that a series of documents as well as precise, detailed information be produced as a precondition to the granting of a marketing authorization, even where the proprietary medicinal product in question is covered by a marketing authorization granted by the competent authority of another Member State.

The Queen v The Medicines Control Agency, ex parte Smith & Nephew Pharmaceuticals Ltd and Primecrown Ltd v The Medicine Control Agency (C-201/94)

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