The forms are intended for applicants for a wholesale distribution authorisation for VMP and for applicants for an amendment and extension of a wholesale distribution authorisation.
You will find the applications themselves, as well as annexes to the applications, including questionnaires, by which the applicant demonstrates compliance with the conditions laid down for wholesale distribution of VMP.
Documents are available in the form of forms - i.e. to be filled in in the parts intended for the applicant. The applicant shall attach annexes to each application in accordance with the list of annexes set out in his or her application. In cases where the submission of an application is linked to the payment of an administrative fee and reimbursement of expenses for professional activities carried out on request pursuant to Section 112 of Act No 378/2007 Coll. on Pharmaceuticals, as amended, the applicant shall also attach pre-filled tax documents (Administrative fee receipt and Certificate of reimbursement of expenses for professional activities carried out within the scope of the ÚSKVBL), on which the ÚSKVBL shall acknowledge receipt of the payment and send them back to the applicant. Detailed information on payments can be found in the ÚSKVBL Guidelines on administrative fees and reimbursement of expenses for professional activities carried out within the scope of the ÚSKVBL, available here.
Documents which are available only in Czech are at this link.