S.L. 437.115 Art. 13Qualified person.

(1) When more than one (1) qualified person is nominated in accordance with Article 97 of Regulation (EU) 2019/6, the application shall clearly indicate the specific responsibilities of each person:

Provided that the qualified person may nominate another person similarly qualified to act as his representative and shall notify the Director of such nomination within one (1) working day.

(2) A person carrying out duties of a qualified person before the coming into force of these regulations shall continue to carry out his duties without the requirements of the provisions of Article 97(2)(3) of Regulation (EU) 2019/6.

(3) If the qualified person started following a course prior to the date on which these regulations became applicable, he may be considered as qualified to carry out the duties thereof:

Provided that he shall have been previously engaged in one (1) or more of the following activities for at least two (2) years before the date on which these regulations became applicable:

(a) in one (1) or more undertakings with a manufacturing authorisation and production supervision; and, or

(b) qualitative and quantitative analysis of active substances, and the necessary testing and checking to ensure the quality of veterinary medicinal products:

Provided further that if the person concerned has acquired the practical experience referred to before the date of the coming into force of these regulations, he shall complete a further one (1) year’s practical experience in accordance with the conditions referred to in sub-regulation (1) immediately before he engages in such activities.

(4) The qualified person shall ensure that standards of good practice in manufacturing are complied with at all times.