S.L. 458.36 Art. 11Responsibility of qualified person.

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

(a) each batch of 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 medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, 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 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 Community.

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

(3) The qualified person shall, in the case of medicinal products intended to be placed on the market in the European Union, ensure that the safety features referred to in regulation 3(o) of the Medicinal Products (Labelling and Packaging) Regulations have been affixed on the packaging.