Article 10 Prior written consent of the ECB

The ECB shall grant prior written consent within a reasonable time limitfor activities listed in point (7) of Article 9in cases where all relevant accreditation requirements and all relevant obligations are complied with by the requesting accredited manufacturer.

The ECB may grant prior written consent subject to an accredited manufacturer’s compliance with any restrictions or obligations which the ECB may impose on the requesting accredited manufacturer.

The ECB may deny prior written consent where it concludes that the accredited manufacturer’s ability to comply with the accreditation requirements or obligations will be compromised if the accredited manufacturer conducts any of the activities listed in point (7) of Article 9.