Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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Cap. 458 · Medicines Act (Cap. 458)

Cap. 458 Art. 44Responsibilities of manufacturer’s licence holder.

Title II - Manufacture of Medicinal Products for Human Use

In KraftAmtlicher Text

It shall be the duty of the holder of a manufacturer's licence -

(a) to immediately inform the Licensing Authority of any change of the qualified person;

(b) to provide authorised officers access to his premises at any reasonable time;

(c) to enable the qualified person to carry out his duties established by or under this Act;

(d) to maintain such records for any transaction in medicinal products as may be established by or under this Act and have such records available for inspection by any authorised officer for such period of time as may be required by or under this Act;

(e) to have at his disposal the services of staff to satisfy the requirements specified by or under this Act in relation to the manufacture, assembly or modification of medicinal products;

(f) to apply in writing to the Licensing Authority of any change proposed or modification required in relation to the licence;

(g) to comply with the regulations or Orders relating to good practice in manufacture as may be established by or under this Act or under any other Act;

(h) to dispose of medicinal products as established by or under this Act or under any other Act;

(i) other responsibilities as may be established from time to time by or under this Act.