Definitions
For the purposes of this Regulation, the following definitions shall apply:
(a)
‘quality management system’ means a formalised system that provides for comprehensive processes, procedures, and responsibilities for achieving quality policies and objectives to coordinate and direct an organisation’s activities and improve its effectiveness and efficiency in this regard on a continuous basis;
(b)
‘performance indicator’ means an item of information collected at regular intervals to monitor the performance of a system;
(c)
‘signal’ means information that arises from one or multiple sources, including observations and experiments, which suggests a potentially new causal association, or a new aspect of a known causal association between an intervention and an adverse event or a set of related adverse events, that is judged likely to justify further investigation of possible causality.
Pharmacovigilance system
1. The marketing authorisation holder’s pharmacovigilance system established and maintained in accordance with Article 77(1) of Regulation (EU) 2019/6 shall meet the requirements laid down in this Regulation.
2. The marketing authorisation holder shall ensure that the pharmacovigilance system:
(a)
is fully functional;
(b)
is covered by a comprehensive quality management system as provided for in Articles 4 to 9 of this Regulation;
(c)
includes a risk management system covering all procedures and processes necessary to optimise safe use and monitor benefit-risk balance of their veterinary medicinal products;
(d)
sets out clearly the roles, responsibilities and required tasks for all parties involved in operating the system;
(e)
provides for proper control over the system and ensures that, when needed, the necessary changes to the system to improve its operation can be carried out;
(f)
is clearly and unambiguously documented in the pharmacovigilance system master file.
3. Marketing authorisation holders shall ensure that the qualified person responsible for pharmacovigilance referred to in Article 77(8) of Regulation (EU) 2019/6 has sufficient control over the pharmacovigilance system in order to promote, maintain and improve compliance with Article 78 of that Regulation. They shall ensure that there is an appropriate procedure in place to identify and deal with any conflicts of interest of the qualified person responsible for pharmacovigilance.
4. Marketing authorisation holders shall have a sufficient number of competent and appropriately qualified and trained personnel working for them in the performance of pharmacovigilance activities.
5. All persons involved in the procedures and processes of the pharmacovigilance system established for the performance of pharmacovigilance activities shall ensure the proper functioning of the system when fulfilling their role for the marketing authorisation holder.
6. Marketing authorisation holders shall establish and document back-up procedures to ensure business continuity with regard to the fulfilment of pharmacovigilance obligations.
7. Marketing authorisation holders shall retain full responsibility for all pharmacovigilance obligations subcontracted to third parties as laid down in Regulation (EU) 2019/6 and in this Regulation.
Qualified person responsible for pharmacovigilance
1. The qualifications and training of the qualified person responsible for pharmacovigilance referred to in Article 77(8) of Regulation (EU) 2019/6 shall include documented experience in pharmacovigilance.
2. The qualified person responsible for pharmacovigilance shall have completed veterinary surgeon training in accordance with Article 38 of Directive 2005/36/EC of the European Parliament and of the Council ( 2 ) . Where such training has not been completed, marketing authorisation holders shall make arrangements to ensure that the qualified person responsible for pharmacovigilance is assisted by a veterinary surgeon on a continuous basis. That assistance shall be duly documented.
