Article 41
In order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements: (a) specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled; (b) have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of medicinal products, in accordance with Article 20; (c) have at his disposal the services of at least one qualified person within the meaning of Article 48. The applicant shall provide particulars in support of the above in his application.