1. The pharmacovigilance system master file shall consist of a main part describing the pharmacovigilance system, together with annexes containing detailed information.
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.
3. The pharmacovigilance system master file shall contain the following Annexes:
(a)
Annex I: a logbook containing records of all changes to the main part of the pharmacovigilance system master file;
(b)
Annex II: additional information regarding the qualified person responsible for pharmacovigilance, assistant veterinary surgeon, and associated back-up arrangements:
(i)
curriculum vitae including information on qualifications and training of the qualified person responsible for pharmacovigilance as referred to in Article 3(1) and, if applicable, the assistant veterinary surgeon as referred to in Article 3(2);
(ii)
a description of the tasks and responsibilities of the qualified person responsible for pharmacovigilance;
(iii)
proof of registration with the pharmacovigilance database;
(iv)
a list of the pharmacovigilance activities that have been delegated by the qualified person responsible for pharmacovigilance to third parties;
(c)
Annex III: additional information on the marketing authorisation holder:
(i)
a list of all veterinary medicinal products covered by the pharmacovigilance system master file, including the international non-proprietary name (INN) of the active substances, if applicable, the Member States in which the product is authorised or registered, the type of procedure for authorisation and the authorisation numbers in each Member State where the product is authorised;
(ii)
a list of reference numbers for other pharmacovigilance system master files held by the same marketing authorisation holder, where applicable;
(iii)
a list of local or regional representatives for the purpose of receiving reports of suspected adverse events, including their contact details, responsibilities and territories, where applicable;
(iv)
a list of the sites where pharmacovigilance activities listed in Article 4(3), (4), (5) and (6) are carried out;
(d)
Annex IV: further details about the quality management system:
(i)
a list of documents, policies, procedures and processes used for the pharmacovigilance activities referred to in Article 4(3), (4), (5) and (6);
(ii)
a list of all scheduled and completed audits including outstanding critical and major findings.;
(iii)
a list of performance indicators and how to use them, as referred to in Article 7, as applicable;
(iv)
the information on training plans and records referred to in Article 6(2);
(v)
the methodology to calculate the factor referred to in Article 14(2);
(vi)
a list of risk management measures and the outcome of risk minimisation measures;
(e)
Annex V: further information on contractual arrangements between marketing authorisation holders and third parties concerning pharmacovigilance activities:
(i)
a list of the activities or services subcontracted by the marketing authorisation holder to third parties to fulfil pharmacovigilance obligations and information on who the activities or services are subcontracted to, including the name and address any subcontractors, where applicable;
(ii)
a list of the tasks of the qualified person responsible for pharmacovigilance referred to in Article 78 of Regulation (EU) 2019/6 that have been totally or partially outsourced and the information on who the activities or services are subcontracted to, including the name and address of the subcontractor(s), where applicable;
(iii)
a list of existing contracts and agreements with third parties, where applicable, including the products and territories concerned.
4. Where appropriate, information may be provided in the form of charts or flow diagrams.
