Chapter 4, Article 24 · Commission Implementing Regulation (EU) 2021/1281

Contents

Article 24Maintenance#

1.Marketing authorisation holders shall keep the pharmacovigilance system master file up to date and revise it, where necessary, to take account of experience gained, and of technical and scientific progress.

2.Marketing authorisation holders shall ensure that the qualified person responsible for pharmacovigilance has permanent access to the pharmacovigilance system master file to fulfil the tasks referred to in Article 78 of Regulation (EU) 2019/6.

3.The pharmacovigilance system master file shall be subject to version control and indicate the date when it was last updated.

4.Marketing authorisation holders shall record in a logbook any alteration to the content of the main part of the pharmacovigilance system master file made within the last 5 years. Marketing authorisation holders shall indicate in the logbook the changed Section, the kind of change, the date, the person responsible and, where appropriate, the reason for the alteration.

5.Marketing authorisation holders shall, upon request, submit a copy of their logbook or another requested part of the pharmacovigilance system master file to the competent authorities or the Agency, as applicable, within 7 days.

6.Marketing authorisation holders shall notify the relevant competent authority or the Agency of any change in the information provided in the summary of the pharmacovigilance system master file by submitting a variation in accordance with Article 61 of Regulation (EU) 2019/6.

7.After the system as described in the pharmacovigilance system master file has been formally terminated, marketing authorisation holders shall keep an electronic version of it for 5 years.