S.L. 458.36 ст. 4Grantorrenewalof a licence.

The Authority, shall only grant or renew a licence, if the applicant:

(a) specifies the medicinal products and pharmaceutical forms which are to be manufactured or imported and the place where they are to be manufactured and, or controlled;

(b) has at his disposal, for the manufacture or import of medicinal products, suitable and sufficient premises, technical equipment and control facilities complying with requirements set by the Authority;

(c) has at his disposal the services of at least one qualified person within the meaning of regulation 8; and

(d) provides all necessary documentation in support of his application.