OM-2.3 OM-2.3 Notifications and prior approval
OM-2.3.1
A licensee must formally notify the Agency and seek its prior approval before committing to a new material outsourcing arrangement.
OM-2.3.2
The above notification must:
(a) be made in writing to the licensee's normal supervisory contact;(b) contain sufficient detail to demonstrate that relevant issues raised in section OM-2.4 onward of this chapter have been addressed; and(c) be made at least 6 weeks before the licensee intends to commit to the arrangement.OM-2.3.3
The Agency will review the information provided and provide a definitive response within 6 weeks of receiving the notification. Where further information is requested from the licensee, however, the time taken to provide this further information will not be taken into account. The Agency may also contact home or host supervisors of the licensee or the service provider, to seek their comments — in such cases, the 6-week turnaround is also subject to the speed of their response.
OM-2.3.4
Once an activity has been outsourced, a licensee must immediately inform its normal supervisory contact at the Agency of any material problems encountered with the outsourcing provider. In exceptional cases, the Agency reserves the right to direct a licensee to make alternative arrangements for the outsourced activity.