The applicant does not have to supply the results of pharmacological, toxicological and clinical tests if he can prove either: — that the new product is essentially similar to a product already on the market in that country, and the person responsible for the existing product is willing to allow the use of his clinical information in the examination of the new product; — or, that there is detailed scientific evidence available showing that the constituents of the product have an acceptable level of safety and recognized efficacy; — or, that the new product is essentially similar to a product that has been authorized elsewhere in the Community for six or 10 years, and is marketed in the Member State in question.
— ή με βάση λεπτομερή και δημοσιευμένη επιστημονική βιβλιογραφία, ότι το ή τα συστατικά του φαρμακευτικού ιδιοκατασκευάσματος είναι καθιερωμένης ιατρικής χρήσεως και παρουσιάζουν αναγνωρισμένη αποτελεσματικότητα και αποδεκτά επίπεδα ασφαλείας'