S.L. 458.35 Art. 36Community reference date.

For the purposes of regulation 35, the Community reference date for medicinal products containing the same active substance or the same combination of active substances shall be one of the following:

(a) the date of the first marketing authorisation in the Community of a medicinal product containing that active substance or that combination active substances;

(b) if the date referred to in paragraph (a) cannot be ascertained, the earliest of the known dates of the marketing authorisations for medicinal products containing that active substance or that combination of active substances.