Chapter 4, Article 22, Paragraph 2. · Commission Implementing Regulation (EU) 2021/1281

Contents

2.The main part of the pharmacovigilance system master file shall contain the following Sections:

(a)Section A containing general information regarding the pharmacovigilance system master file:

(i)pharmacovigilance system master file reference number;

(ii)pharmacovigilance system master file location for the purpose of pharmacovigilance inspections in accordance with Article 126(4) of Regulation (EU) 2019/6;

(b)Section B containing information regarding the qualified person responsible for pharmacovigilance, assistant veterinary surgeon and associated back-up procedures:

(i)information on the qualified person responsible for pharmacovigilance including name, contact details and a signed statement from the marketing authorisation holder and the qualified person confirming that the qualified person concerned has the necessary means to fulfil the tasks and responsibilities required by Regulation (EU) 2019/6;

(ii)documentation on the marketing authorisation holder arrangements concerning the assistant veterinary surgeon referred to in Article 3(2), if applicable, including the contact details;

(iii)a description of back-up arrangements that apply in the absence of the qualified person responsible for pharmacovigilance or the veterinary surgeon, assisting the qualified person responsible for pharmacovigilance referred to in Article 2(6);

(c)Section C containing information on the marketing authorisation holder:

(i)a detailed description of the organisational structure of the marketing authorisation holder, including a parent company or group of companies associated;

(ii)the position of the qualified person responsible for pharmacovigilance within the organisation.

(d)Section D containing a description of the document management system referred to in Article 5, including the record management system for adverse event recording referred to in Article 10;

(e)Section E containing a description of the quality management system for pharmacovigilance activities, including all of the following:

(i)a description of the processes used for pharmacovigilance activities referred to in Article 4(3), (4), (5) and (6);

(ii)a description of the training management system in place referred to in Article 6(2);

(iii)a description of the system used for documenting or archiving information referred to in Article 5(2);

(iv)a description of the system for monitoring the performance of the pharmacovigilance system as referred to in Article 7;

(v)a description of the responsibilities for quality assurance auditing of the pharmacovigilance system as referred to in Article 8 including, where appropriate, auditing of subcontractors;

(vi)a list of audits associated with unresolved critical or major findings;

(vii)a description of the corrective and preventive action plan management and change management in place as referred to in Article 9;

(f)Section F containing a description of the contractual arrangements between marketing authorisation holders and third parties concerning pharmacovigilance activities, where applicable.