The sphere of distribution 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)
- Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
Prior to the commencement of the distribution activity it is necessary to apply with SÚKL for the authorisation of distribution of medicinal products. The particulars of the application are stipulated in Section 45 of Decree No 229/2008 Coll., on the Manufacture and Distribution of Pharmaceuticals and further information is also provided in SÚKL guideline DIS-8.
SÚKL shall confirm the receipt of the application and following the check of accompanying documentation 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.
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