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

Cap. 458 Art. 39Granting of manufacturer’s licence.

Title II - Manufacture of Medicinal Products for Human Use

In KraftAmtlicher Text

(1) The Licensing Authority shall, before determining an application, inspect the premises indicated in the application and shall not issue a licence until it is satisfied that such premises conform with the requirements established by or under this Act: Provided that a licence may be made conditional to the carrying out of such obligations as may be imposed therein.

(2) The manufacturer's licence shall specify the premises and the medicinal products and pharmaceutical form or forms to which it applies.

(3) The licence holder shall ensure that the activity is carried out in accordance to the provisions of this Act and any regulations made thereunder.