EU Strengthening Regulatory Oversight of PV Subcontracting
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28 Sep EU Strengthening Regulatory Oversight of PV Subcontracting

Posted at 08:56h in Pharmacovigilance by

Supplier qualification, ongoing oversight and quality management of subcontractors have always been integral parts of an effective pharmacovigilance (PV) system. In the context of the recent legislative development (Implementing Regulation (EU) 2025/1466) the importance of the contractual clarity with service providers was reinforced and marketing authorisation holders (MAHs) must ensure all agreements with third parties – including subcontractors – clearly outline roles, responsibilities and audit rights. Third parties must agree to be audited by or on behalf of marketing authorisation holders and inspected by the competent authorities in order to guarantee and verify compliance concerning all aspects of the pharmacovigilance system. Crucially, third parties cannot further subcontract any assigned PV task without the MAH’s prior written consent.

Following the amendments introduced with Commission Implementing Regulation (EU) 2025/1466, in September 2026 EMA updated the GVP arrangements in relation to subcontracting (GVP: Module III – Pharmacovigilance inspections, Rev. 2). The vendors of the subcontractors engaged with pharmacovigilance tasks are also brought within the scope of the relevant subcontracting requirements. Such third parties may be subject to inspection by the competent authorities, including inspection of relevant premises, records and documents.

Furthermore, any third party subcontracted to conduct pharmacovigilance tasks in whole or in part on behalf of or in conjunction with MAHs may be inspected by the competent authorities, even if the obligation for the third party to agree to such inspection has not yet been included in the subcontract.