Article 12
Renewal of authorisations 1. Without prejudice to Article 11, authorisations under this Regulation shall be renewable for 10-year periods on application to the Commission by the authorisation holder, at the latest 18 months before the expiry date of the authorisation. 2. The application shall be accompanied by the following particulars and documents: (a) a reference to the original authorisation; (b) any available information concerning the points listed in Annex II which supplements the information already provided to the Authority in the course of the previous evaluation(s) and updates this in the light of the most recent scientific and technical developments; (c) a reasoned statement affirming that the product complies with Article 4(1), first indent. 3. Articles 7 to 9 shall apply mutatis mutandis. 4. Where, for reasons beyond the control of the authorisation holder, no decision is taken on the renewal of an authorisation until one month before its expiry date, the period of authorisation of the product shall automatically be extended by six months. The Commission shall inform the authorisation holder and the Member States about the delay.