1
The licence shall be issued if:
a.
the necessary technical and operational conditions are fulfilled;
b.
an appropriate system of quality assurance exists.
2
The licence shall also be issued to the applicant who already possesses a manufacturing licence for medicinal products. Furthermore, the licence referred to in Article 18 paragraphs 1 letters b and c shall be issued to the applicant already possessing a licence for the import or wholesale trade of medicinal products.
3
The competent authority shall verify by inspection that the conditions are fulfilled.