30If the competent national authority concludes that the proprietary medicinal product to be imported does not satisfy all the abovementioned criteria and cannot therefore be regarded as having already been placed on the market in the Member State of importation, it cannot issue the new marketing authorization required for the marketing of the product to be imported unless the conditions listed in Directive 65/65, as amended by Directive 87/21, are fulfilled. The discretion enjoyed by the competent authority of the Member State under the directive is very limited. It cannot, on any view, extend to the possibility of issuing a marketing authorization under Article 3 of Directive 65/65 when the information referred to in Article 4 of that directive has not been supplied in full and the tests referred to therein have not been performed. Such a marketing authorization may be issued only when it is shown that all the obligations set out in Article 4 have been complied with (see Case C-440/93 R v Licensing Authority of the Department of Health, ex parte Scotia Pharmaceuticals [1995] ECR I-2851).
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