Paragraph 56 Duties of marketing authorisation holder in relation to pharmacovigilanceF1E1

The marketing authorisation holder is responsible for pharmacovigilance in relation to a veterinary medicinal product for which it holds a marketing authorisation and must continuously evaluate, by appropriate means, the benefit-risk balance of this veterinary medicinal product and, if necessary, take appropriate measures to address any risk presented by the product.

A marketing authorisation holder must carry out the signal management process mentioned in paragraph 56C in relation to any veterinary medicinal product for which it holds an authorisation.

A marketing authorisation holder must comply with best practice in good veterinary pharmacovigilance practice.

A marketing authorisation holder must establish and maintain a system for collecting, collating and evaluating information in relation to suspected adverse events in respect of any veterinary medicinal product for which it holds an authorisation.

Subject to sub-paragraph (6), a marketing authorisation holder must establish and maintain one or more pharmacovigilance system master files describing in detail the pharmacovigilance system with respect to its authorised veterinary medicinal products.

For each veterinary medicinal product, the marketing authorisation holder must not establish and maintain more than one pharmacovigilance system master file.

A marketing authorisation holder must establish and maintain an adequate and effective local system for the purpose of receiving reports of suspected adverse events.

The system mentioned in sub-paragraph (7) must be staffed by personnel trained for this purpose who are able to communicate in English.

A marketing authorisation holder must designate not more than one qualified person responsible for pharmacovigilance (a “qualified person (pharmacovigilance)”) in relation to each pharmacovigilance system master file whose services are available permanently and continuously.

Where the pharmacovigilance functions or the functions of the qualified person for pharmacovigilance are performed by a third party, any such arrangement must be specified in detail in the pharmacovigilance system master file and within appropriate pharmacovigilance agreements.

A marketing authorisation holder may introduce urgent safety restrictions where evidence comes to the attention of the holder of a risk posed to human or animal health or to the environment from the use of the product.

Where a marketing authorisation holder takes any action under sub-paragraph (11) the holder must inform the Secretary of State no later than the following working day of the reasons for the action.

A marketing authorisation holder must establish and maintain an adequate and effective quality management system for the performance of its pharmacovigilance activities.

The Secretary of State may at any time by notice require a marketing authorisation holder to provide a copy of the pharmacovigilance system master file.

A marketing authorisation holder who is given notice under sub-paragraph (14) must comply with the requirement within seven days of receipt of the notice.