S.L. 458.35 Art. 6Duty of the marketing authorisation holder.

(1) The marketing authorisation holder shall operate a pharmacovigilance system for the fulfilment of his pharmacovigilance tasks equivalent to the relevant Member State’s pharmacovigilance system provided for under regulation 3.

(2) The marketing authorisation holder shall, by means of the pharmacovigilance system referred to in sub-regulation (1), evaluate all information scientifically, consider options for risk minimisation and prevention and take appropriate measures as necessary.

(3) The marketing authorisation holder shall perform a regular audit of his pharmacovigilance system. He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and implemented. Once the corrective actions have been fully implemented, the note may be removed.

(4) As part of the pharmacovigilance system, the marketing authorisation holder shall:

(a) have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance;

(b) maintain and make available on request a pharmacovigilance system master file;

(c) operate a risk management system for each medicinal product;

(d) monitor the outcome of risk minimisation measures which are contained in the risk management plan or which are laid down as conditions of the marketing authorisation;

(e) update the risk management system and monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the benefit-risk balance of medicinal products: Provided that the qualified person referred to in paragraph

(a) shall reside and operate in the European Union and shall be responsible for the establishment and maintenance of the pharmacovigilance system. The marketing authorisation holder shall submit the name and contact details of the qualified person to the Authority and the Agency:

Provided further that by way of derogation from the preceding proviso, where the marketing authorisation is granted by the competent authority of the United Kingdom in respect of Northern Ireland, the qualified person referred to in paragraph (a) of this sub-regulation may reside and operate in parts of the United Kingdom other than Northern Ireland. This proviso shall not apply where the marketing authorisation holder already has at its disposal a qualified person who resides and operates in the European Union on 20 April 2022.

(5) Notwithstanding the provisions of sub-regulation (3), the Authority may request the nomination of a contact person for pharmacovigilance issues at national level reporting to the qualified person responsible for pharmacovigilance activities.