S.L. 458.37 ст. 10Duty of responsible person.

It shall be the duty of the responsible person to:

(a) ensure that the licence conditions are adhered to;

(b) ensure that the conditions for storage of medicinal products are in accordance with the requirements of the marketing authorisation and labelling;

(c) monitor all areas used for storage and distribution;

(d) maintain records as required by these regulations;

(e) ensure that a quality system is maintained by the licensee in accordance with good distribution practice.