The referring court seeks to ascertain whether a prescription-only medicinal product for human use, for which no marketing authorisation has been granted by the competent authority in a Member State or pursuant to Regulation No 726/2004, (7) is covered by either of the exceptions in Article 3(1) or (2) of Directive 2001/83, in particular in a situation where there is another authorised medicinal product with the same active substance, same dosage and same pharmaceutical form.
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