Article 6: Subcontracting

1.   The marketing authorisation holder may subcontract certain activities of the pharmacovigilance system to third parties. It shall nevertheless retain full responsibility for the completeness and accuracy of the pharmacovigilance system master file.

2.   The marketing authorisation holder shall draw up a list of its existing subcontracts between it and the third parties referred to in paragraph 1, specifying the product(s) and territory(ies) concerned.