S.L. 437.47 Art. 49Responsibilities of the qualified person.

(1)The qualified person, without prejudice to his relationship with the holder of the Authorisation, shall be responsible to ensure that:

(a) each batch of veterinary medicinal products manufactured in Malta has been manufactured and checked in terms of the laws in force and is in accordance with the requirements of the marketing authorisation;

(b) in the case of veterinary medicinal products coming from third countries, irrespective of whether the product has been manufactured in the EU, each production batch has undergone in a Member State 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 the veterinary medicinal product in accordance with the requirements of the marketing authorisation:

Provided that when the batches of medicinal products have already undergone the controls above mentioned in a Member State, they shall be exempt from further controls if they are accompanied by the control reports signed by the qualified person, and are marketed within the EU;

(c) standards of good practice in manufacturing are complied with at all times.

(2) The qualified person need not carry out the controls above mentioned in the case of imported veterinary medicinal products, where arrangements have been made by the EU with the exporting country to ensure that the manufacturer of the veterinary medicinal products applies standards of good manufacturing practice at least equivalent to those laid down by the EU, and to ensure that the controls referred to above have been carried out in the exporting country.

(3) The Veterinary Services, may if it has reasonable suspicion to believe that any qualified person is acting in contravention of any of the provisions of these regulations, suspend the activity of such qualified person by notice in writing specifying the reasons for such suspension until such person has complied with any requirement of the Veterinary Services to remedy the non-compliance.