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
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
- Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)
- Guideline of State Institute for Drug Control DIS-8
- Guideline of State Institute for Drug Control DIS-10
- Guideline of State Institute for Drug Control DIS-13
- Guideline of State Institute for Drug Control DIS-15
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 (WDA) 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 (WDA) 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.eu, 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 (WDA) document issued by the concerned state (in the Czech or English translation). The holder of a distribution authorisation (WDA) 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 (WDA) issued by the State Institute for Drug Control.
In accordance with § 77 par. 1 point. f) of the Act No. 378/2007 Coll., on pharmaceuticals and on amendments to some related laws, the distributor is obliged to regularly provide complete and accurate data on the volume of medicines, which were distributed to the Czech Republic. Scope and method of providing data is listed in the guideline DIS-13 current version, which is available in English.
About setting up an account for providing of reports on supply of medicinal products to the Czech Republic, it is necessary to ask the Institute.
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:
Správné distribuční praxe
602 00 Brno
tel: +420 272 185 405
Contact person: PharmDr. Gabriela Vaculová – Head of GDP department