These Q&As are based on the Pharmacovigilance Inspectors Working Group’s interpretation of Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Commission Implementing Regulation (EU) 2021/1281. Q&As may refer to previous pieces of legislation and guidance but they are valid (unless they are marked as obsolete) by analogy.
The marketing authorisation holder should appropriately define, agree and control any pharmacovigilance activity it outsources to a third party (the contract acceptor).
In Volume 9B, Part I, Section 1.3 it is clearly stated that a MAH may transfer any or all of the pharmacovigilance tasks and functions, including the role of the qualified person for pharmacovigilance (QPPV), to (an)other person(s) or organisation(s), but the ultimate responsibility for the fulfilment of all pharmacovigilance obligations and the quality and integrity of this always reside with the MAH. In such cases, it is the responsibility of the MAH to ensure that detailed and clear documented contractual arrangements are in place between MAHs and persons or organisations involved in the fulfilment of pharmacovigilance obligations and to provide the national competent authorities and, if applicable, the Agency, with information on such arrangements in line with the requirements set out in Volume 9B, Part I, Chapter 2: “Requirements for pharmacovigilance systems, monitoring of compliance and pharmacovigilance inspections”.
The MAH should identify the major subcontracting arrangements it has for the conduct of its pharmacovigilance activities and the main organisations to which it has subcontracted these (in particular where the subcontracted activities relate to the role of the QPPV, the electronic reporting of adverse events, the main databases, signal detection, the compilation of periodic safety update reports, literature search, etc.).
According to Volume 9B, Part I, Section 2.3.3 e), links with other organisations such as co-marketing agreements and contracting of pharmacovigilance activities should be outlined in the detailed description of pharmacovigilance system (DDPS).
The MAH should have the means to verify:
This verification may be carried out, for example, by on-site or “distant” audits. The contract should clearly state the MAH's right to perform audits. According to Volume 9B, Part I, Section 1.3 ”the contracted person(s) or organisation should implement quality assurance and quality control and should accept to be audited by or on behalf of the MAH”.
In order to ensure that pharmacovigilance activities managed by a MAH in collaboration with another party are carried out in compliance with existing legislation/guidelines, the agreement between the two parties should be formalised in a written contract.
A pharmacovigilance agreement is expected to be drawn up in the form of a contract, in accordance with the recommendations detailed below.
The contract should:
Contracts are expected to contain at least the following information:
Staff involved to any extent in pharmacovigilance activities should be trained at an appropriate level and on a continuous base in pharmacovigilance. Moreover, training should always be provided after any change which affects the pharmacovigilance system (organization, procedures, etc).
The process of training for all staff should be described in writing (e.g. in a standard operating procedure).
An “appropriately qualified” QPPV should have a scientific background, best it would be a veterinarian with experience in the field of veterinary medicinal products (VMPs).
The QPPV is expected to have adequate knowledge in veterinary pharmacovigilance. This is normally achieved by attending a basic (initial) training followed by participation to (best external) training events on pharmacovigilance performed on a continuous base (the recommendation is at least once a year).
Documented evidence that the QPPV is keeping constantly updated on pharmacovigilance (legislation, procedures, guidelines, etc.) is also normally recognised appropriate as proof of the fulfilment of training requirements of the QPPV
Pharmacovigilance dedicated staff is expected to have adequate knowledge in veterinary Pharmacovigilance. This is normally achieved by attending a basic (initial) training followed by participation to (best external) continued events on pharmacovigilance performed on a continuous base (the recommendation is at least once a year).
Documented evidence that pharmacovigilance dedicated staff is keeping constantly updated on pharmacovigilance (legislation, procedures, guidelines, etc.) is also normally recognised as appropriate as proof of the fulfilment of training requirements of pharmacovigilance-dedicated staff.
Initial training, followed by a periodic refresher training, is considered appropriate for all staff who could possibly come in contact with adverse events. The frequency of the periodic training should be evaluated on a case by case basis.
The above mentioned training has to include: (i) the recognition of adverse events including lack of efficacy, (ii) the collection of minimum information for adverse event reports and (iii) the importance of timely forwarding the information to the appropriate person.
*e.g. sales representatives, telephone operators, product managers, field trial/clinical research staff, other MAH staff who could first come in contact with adverse events.
The above interpretation of training needs is based on the requirements identified in the following sections of Volume 9B:
If external staff can come into contact with pharmacovigilance activities concerning veterinary medicinal products of the MAH, this staff has to be trained.
The MAHs should ensure this by including external staff in their internal training programs or by carrying out audits.
Relevant contracts should include the training requirements of external staff and the MAH's right to audit them.
According to Volume 9B:
Documents demonstrating the title, the date, the lecturer, the participants, and the content of the training (e.g. training lecture notes, presentations or scripts for the participants) should be archived. The relation to pharmacovigilance for veterinary medicinal products should be apparent in the documents.
Not only the occurrence of a training should be documented, but also its effectiveness. Effectiveness could be documented, for example, by a test taken after the training. The training test and its outcome should be archived.
A document signed by the trainers, stating that the relevant trained staff has attended the training and understood its contents, should be available.
This whole training process should be described in writing (e.g. in a standard operating procedure).
The MAH should ensure that employees absent during a training event will get the opportunity to attend the same training on another date (as soon as possible).
A system should be in place to keep track of pending training. Training effectiveness should be ensured as mentioned in question 3.
This process should be described in writing (e.g. in a standard operating procedure).
If a given training has not proven to be effective for one or more participants, they should be retrained and should be given the possibility to clarify any residual doubts. Misunderstandings should be explained, all clarifications should be documented and the effectiveness of the training should be verified again.
In the case of an initial training or a training on new job duties, the trainee can only start his activity when the training has been considered effective.
This process should be described in writing (e.g. in a standard operating procedure).
Archiving can be paper-based or electronic.
If a company chooses to archive paper documents electronically, they should put in place a quality control of the process.
For data security and safe archiving, the same rules as for other pharmacovigilance documents apply (Volume 9B, Part I, Section 2.3.3 c), f) & g)).
In the detailed description pharmacovigilance system (DDPS), a brief description of the locations of the different types of pharmacovigilance source documents, including archiving arrangements, should be provided. Archiving should be performed according to a written procedure that also indicates where training records, CVs and job descriptions are filed.
The required duration of archiving is usually determined by national rules.
The MAH should ensure that the following evidence is readily available for inspection in order to give proof that staff involved in pharmacovigilance activities is properly trained: