25By way of derogation from Article 8(3)(i) of Directive 2001/83, Article 10a thereof provides that an applicant for a MA for a given medicinal product is not required to provide the results of pre-clinical tests or clinical trials and that these may be replaced by appropriate scientific literature if the applicant can demonstrate, in accordance with the conditions set out in Annex I to the directive, that the active substances of the medicinal product have been in well-established medicinal use within the EU for at least 10 years, with recognised efficacy and an acceptable level of safety.
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