State Institute for Drug Control

The sphere of distribution of medicinal products in the Czech Republic is governed by the following regulations: 

• Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts  - Section 75 to Section 78            
• Act No 500/2004 Coll., the Administrative Procedure Code, as amended
• Act No 634/2004 Coll., on Administrative Fees
• Decree No 229/2008 Coll., on the Manufacture and Distribution of Pharmaceuticals  - Section 35 to Section 41, Section 42, Section 45
• Compilation of Community Procedures on Inspections and Exchange of Information, March 2004   

A)     Distribution to the Czech Republic from another EU Member State (the distributor does not have any established distribution warehouse within the territory of the Czech Republic)

A distributor – holder of a distribution authorisation issued by the competent authority of another Member State is obliged to notify in advance the competent institute of the commencement of distribution in the Czech Republic, to evidence the distribution authorisation issued by another Member State, to provide information necessary to ensure cooperation therewith and other information about the scope of distribution and location of distribution warehouses. The form for the notification of commencement of distribution activities (including the required data) is provided in SÚKL guideline DIS-10, available from www.sukl.cz, the Guidelines and Forms – Distribution of pharmaceuticals section, and may be downloaded here.  The form is also available from the English version of SÚKL website, and may be downloaded here. The attachment to the application shall be an effective distribution authorisation document issued by the concerned state (in the Czech or English translation). The holder of a distribution authorisation issued by the competent authority of another Member State has the same rights and obligations in the Czech Republic as a holder of a distribution authorisation issued by the State Institute for Drug Control or the Institute for the State Control of Veterinary Biologicals and Medicaments.

B)     Distribution from distributor's internal warehouse facilities within the territory of the Czech Republic

Prior to the commencement of distribution activities it is necessary to apply with the Institute for the issue of an authorisation for distribution of medicinal products. The particulars of the application are stipulated by Section 45 of Decree No 229/2008 Coll., the details being specified by SÚKL guideline DIS-8, which is available from www.sukl.cz, the Guidelines and Forms – Distribution of pharmaceuticals section, and may be downloaded here. It is not available in English. The address for submission of the application is as follows:

SÚKL Oddělení Správné distribuční praxe
Jilemnického 2/4
614 00 Brno
tel: +420 272 185 417
e-mail: vratislav.krupka@suklcz
Contact person: MVDr. Vratislav Krupka – GDP department manager

The application for authorisation of distribution of medicinal products has to contain the following:

1. The completed authorisation application form (part of DIS-8) 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;   

1. 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- version 8): 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, version 8, available from  www.sukl.cz , the Guidelines and Forms – General guidelines section or from here. The payment may also be made by bank transfer – the procedure is outlined at www.sukl.cz  - Pricelist and Fees. The reimbursement of costs of expert activities conducted upon request (procedure outlined in the UST-29- version 8 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, the Pricelist and Fees section. The form may be downloaded here.  In the interactive form, complete the details pertaining to the application, and attach to the application 2 counterparts of the form and a copy of the payment order endorsed by your bank. The amounts of reimbursements applicable to the authorisation of distribution are provided in the table of guideline

UST-29 v. 8 (Application codes I-011 to I-015):  

e) consent with personal data processing (natural persons) - Annex to DIS-8.  

The administrative procedure for the issue of distribution authorisation: 

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 as referred to in part 1, letters a), c) to e).