The application for authorisation of distribution of medicinal products has to contain the following:
- The completed authorisation application form (1st page of DIS-8 – is not available in English) specifying the following:
a) the name, surname, business address, identification number (natural person); the name, business company, registered office, identification number (legal person);
b) the name and surname of the statutory body of the person referred to under letter a);
c) the type and scope of distribution applied for;
d) addresses of all sites (warehouse facilities), where distribution is to be carried out;
e) the name, surname, certificate of education (copy of a diploma), overview of practical experience, and certificate of trustworthiness (extract from the Penal Register) for the qualified person;
f) phone, fax and email contact details of the applicant; - Attachments as listed in the application form:
a) a document evidencing the business licence (extract from the Companies Register, the trades licence, the charter) – an authenticated copy;
b) a document evidencing the right to use the premises, buildings, rooms and facilities for distribution (an extract from the Land Register, contract of lease);
c) the completed distributor questionnaire (Annex to DIS-8) – information about compliance with GDP requirements + map of the warehouse facilities, complaints code, and procedure for recalls of pharmaceuticals; where contracted distribution is concerned, also a copy of the contract on the provision of distribution services;
d) proof of payment of the administrative fee for submission of the application and proof of payment of the costs of expert activities conducted upon request (UST-29- actual version): The administrative fee in the amount of 2,000,- CZK shall be paid in the form of revenue stamps attached to the form which forms an annex to SÚKL guideline UST-29, actual version, the Guidelines and Forms – General guidelines section or from. The payment may also be made by bank transfer – the procedure is outlined at Pricelist and Fees. The reimbursement of costs of expert activities conducted upon request (procedure outlined in the UST-29- actual version guideline) shall be made by bank transfer following the generation of the variable symbol via the interactive form which is available from www.sukl.cz, in the Pricelist and Fees section. In the interactive form, complete the details pertaining to the application, and attach to the application 2 counterparts of he form and a copy of the payment order endorsed by your bank. The amounts reimbursements applicable to the authorisation of distribution are provided in the table of guideline UST-29 (Application codes I-011 to I-015):
I-011 Application for authorisation of distribution of medicinal products or for variation to a distribution authorisation (WDA) with inspection With one warehouse inspection 25 300,- CZK (by request submitted until 31. May 2019) / 41 900,- CZK (by request submitted after 1. June 2019)
I-012 For every other warehouse within a single authorisation 13 300,- CZK (by request submitted until 31. May 2019) / 21 600,- CZK (by request submitted after 1. June 2019)
I-013 Application for the extension of distribution authorisation (WDA) for the distribution of active substances and excipients or for the distribution of blood, its components and intermediate products With one warehouse inspection 25 300,- CZK (by request submitted until 31. May 2019) / 41 900,- CZK (by request submitted after 1. June 2019)
I-014 For every other warehouse within a single authorisation 13 300,- CZK (by request submitted until 31. May 2019) / 21 600,- CZK (by request submitted after 1. June 2019)
I-015 Application for variation to an authorisation of distribution (WDA) of medicinal products without inspection 7 400,- CZK (by request submitted until 31. May 2019) / 12 800,- CZK (by request submitted after 1. June 2019)
e) consent with personal data processing (natural persons) - Annex to DIS-8.
The administrative procedure for the issue of distribution authorisation (WDA):
SÚKL shall confirm receipt of the application, and following the check of submitted documents may, if applicable, invite the applicant in writing to supplement it. Where the application is complete, the Institute shall, following the verification of compliance with requirements set forth by the law and the implementing regulations, including an on-site inspection carried out by the inspectors of the Institute, issue a decision on the authorisation of distribution of medicinal products. The timeline for processing the application is 90 days.
Please note: The duty to apply for a variation to authorisation is also applicable to subsequent changes made to the data provided in the application for distribution authorisation (WDA) as referred to in part 1, letters a), c) to e).
Request for change of authorization of distribution of medicinal products and Request for cancellation of the authorization are a part of application form (page 2 and 3 of DIS-8 - is not available in English)
cz