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.
3. Without prejudice to the second sentence of paragraph 1 and to Article 11(2), the marketing authorisation holder shall include in the subcontracts the following elements:
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(a) |
a clear description of the roles and responsibilities of the third parties to whom pharmacovigilance activities are subcontracted; |
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(b) |
obligation of third parties to exchange with the marketing authorisation holder safety data and the method for exchanging safety data, if relevant; |
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(c) |
arrangements for inspection and auditing process of third parties; |
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(d) |
obligation of the third parties to agree to be audited by or on behalf of the marketing authorisation holder and inspected by competent authorities. |
This paragraph applies mutatis mutandis to the third parties that subcontract the tasks subcontracted to them by the marketing authorisation holder.
4. Third parties shall not subcontract any pharmacovigilance task assigned to them by the marketing authorisation holder without the marketing authorisation holder’s written consent.