Role of the Qualified Person

1)       To ensure that each batch of the medicinal product to which the Licence relates has been manufactured or assembled and checked in compliance with the provisions of the Licence and Product Licence/Marketing Authorisation which relates to the product.

2)       To certify in a register, or other record appropriate for the purpose, whether each production batch of the medicinal product to which the licence or authorisation relates satisfies the requirements set out above and to ensure that such register or other record is regularly maintained, and that the appropriate entries in such register or other record are made as soon as practicable after each such batch has been manufactured.

3)       For medicinal products manufactured outside GB or EU, the Qualified Person must ensure that each imported batch has undergone a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the Marketing Authorisation.

4)       In the case of medicinal products imported from outside GB or EU, where appropriate arrangements have been made with the exporting country to ensure that the manufacturer of the medicinal product applies standards of GMP at least equivalent to those laid down by the QP Study Guide 2021 Page 14 of 15 UK and to ensure that the controls referred to above have been carried out in the exporting country, the Qualified Person may be relieved of responsibility for carrying out those controls.

5)       For supply into NI the QP must also ensure that the requirements in 2016/161/EU (delegated regulation for safety features) are met.