Contents
Article 5Document management system#
1.Marketing authorisation holders shall set up and maintain a document management system to keep all documents related to pharmacovigilance activities. Those documents shall be archived and indexed to enable accurate and easy accessibility throughout the period of record-keeping.
2.Documents shall be subject to version control, as appropriate.
3.Documents and pharmacovigilance data relating to individual authorised veterinary medicinal products shall be retained as long as the product is authorised and for 5 years after the marketing authorisation ceases to be valid.
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