S.L. 437.47 Art. 67Qualified person responsible for pharmacovigilance

The marketing authorisation holder shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.

That qualified person shall reside in the European Union and shall be responsible for the following:

(a) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, including its representatives, is collected and collated in order to be accessible at least at one point within the European Union;

(b) the preparation for the Veterinary Services of the reports referred to in regulation 68, in such form as may be laid down by that authority, in accordance with the guidance referred to in regulation 70(1);

(c) ensuring that any request from the Veterinary Services for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a veterinary medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the veterinary medicinal product concerned;

(d) the provision to the Veterinary Services, of any other information relevant to the evaluation of the benefits and risks afforded by a veterinary medicinal product, including appropriate information on post-marketing surveillance studies.