57It should be noted that an applicant for marketing authorisation for a medicinal product essentially similar to a product authorised for at least six or 10 years in the Community and marketed in the Member State for which the application is made is not required, under Article 4.8(a)(iii) of Directive 65/65, as amended, to supply pharmacological, toxicological and clinical documentation for any of the therapeutic indications to which the documentation for the original medicinal product relates, including those authorised for less than six or 10 years (see, to that effect, Generics, paragraphs 43 and 44).
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