Medicinal products
- Form 515-01 Medicinal product production – General part of the application
- Form 516-01 Medicinal product production – Specific part of the application – Attachment 1 – Production activities
- Form 517-01 Medicinal product production – Specific part of the application – Attachment 2 – Analytical testing
- Form 518-01 Medicinal product production – Specific part of the application – Attachment 3 – Import
- Form 519-01 Medicinal product production – Specific part of the application – Attachment 4 – Clinical testing
- Form 520-01 Entry into the register of persons responsible for releasing individual batches of medicinal products
Active substances
- Form 521-01 Entry in the register of manufacturers, wholesalers and importers of active substances