Commentaries: Art. 12

The application for a marketing authorisation for a medicinal product which is essentially the same as a medicinal product whose documents are protected in accordance with Articles 11a or 11b may be based on the results of the pharmacological, toxicological and clinical tests if:
1. the holder of the marketing authorisation for the medicinal product with document protection provides written permission; or
2. the protection period for the relevant documents has expired.
If the holder of the marketing authorisation does not agree, the granting of a marketing authorisation for an essentially identical medicinal product shall be permissible at the earliest on the first day after expiry of the period of protection for the medicinal product with document protection.A corresponding application for marketing authorisation may be submitted at the earliest two years before the end of the term of protection.