Commission Implementing Regulation (EU) No 520/2012 Article 6

Subcontracting

Article 6

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.

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Other provisions in CHAPTER I — Pharmacovigilance system master file

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 6 of Commission Implementing Regulation (EU) No 520/2012 (LawPlayer, data as of 2026-07-04)

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