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

Cap. 458 Art. 45Responsibilities of the qualified person.

Title II - Manufacture of Medicinal Products for Human Use

In KraftAmtlicher Text

(1) The responsibilities of a qualified person shall be:

(a) to ensure that standards of good practice in manufacturing are complied with at all times;

(b) to ensure that each batch of medicinal products has been manufactured, tested and complies in all respects with any requirement established by or under this Act; and

(c) to ensure that each batch of medicinal products has been manufactured in accordance with the requirements of the marketing authorisation.

(2) The qualified person shall be permanently and continuously at the disposal of the holder of the manufacturer’s licence:

Provided that the qualified persons may nominate another person similarly qualified to act as his representative.

(3) When the qualified person has nominated a representative as aforesaid he shall immediately inform the Licensing Authority of such nomination.