In brief
Oversight of psychomodulatory substances (PML) in the Czech Republic is divided among several state authorities. None of them has exclusive competence - the system is built on the cooperation of departments. The main actors are the Ministry of Health, the State Institute for Drug Control (SÚKL), the Customs Administration, the Czech Trade Inspection (ČOI), the Agriculture and Food Inspection Authority (SZPI) and the National Drug Headquarters of the Czech Police (NPC PČR).
Ministry of Health (MZ ČR) - coordinating role
The MZ ČR is the central state-administration body for the field of PML under Act No. 2/1969 Coll., on the establishment of ministries. Its main competences within 167/1998 Coll.:
- issuing licences to handle PML,
- keeping a register of licence holders,
- deciding on the classification of new substances on the PML list,
- issuing implementing decrees to the Act,
- receiving notifications of individual imports.
The MZ ČR coordinates the activity of the other authorities and manages the inter-departmental agenda on PML.
SÚKL - State Institute for Drug Control
SÚKL is an organisational unit of the MZ ČR specialising in the control of medicines. In the context of PML it provides:
- expert assessment of licence applications (quality of the warehouse, records, responsible persons),
- control of PML batches for the content of the declared alkaloids,
- assessment of applications to classify new substances on the PML list,
- monitoring of safety signals from the market (e.g. findings of contaminants).
SÚKL does not issue licences (the MZ ČR does), but provides an expert opinion that is significant for the issue of a licence.
Czech Customs Administration - import control
The Customs Administration controls the import and export of PML across the EU's external border. Specific tasks:
- checking customs declarations and accompanying documents,
- physical inspection of consignments based on risk analysis,
- cooperation with the MZ ČR and SÚKL in checking compliance with the PML licence,
- detaining consignments without valid documents.
ČOI - Czech Trade Inspection
The ČOI oversees the retail level: the conformity of products with the declared labelling, compliance with information obligations and the ban on sale to persons under 18. The ČOI's powers in the field of PML:
- test purchases (including undercover ones, especially to detect sales to minors),
- checking labels and packaging,
- imposing a fine for an administrative offence.
SZPI - Agriculture and Food Inspection Authority
The SZPI oversees plant materials within the official controls of food and feed under EU Regulation 2017/625. In the context of PML its role is indirect (PML is not a food), but it applies especially at the boundary between PML and food supplements.
NPC of the Czech Police - investigation of violations
The National Drug Headquarters of the Czech Police (part of the Criminal Police Activities Unit) investigates criminal offences related to the unauthorised distribution of PML. Specific areas:
- illegal import and distribution without a licence,
- distribution to minors,
- forgery of PML licences or certificates,
- cooperation with international bodies (Europol, Interpol).
Cooperation and inter-departmental coordination
Act No. 167/1998 Coll. imposes on the aforementioned authorities the duty of mutual cooperation and the sharing of relevant information. In practice, coordination takes place mainly:
- at the level of the Inter-departmental Anti-Drug Commission at the Government Office,
- through the PML Control Board at the MZ ČR,
- at the level of technical cooperation between SÚKL and the Customs Administration.
Frequently asked questions
Does SÚKL issue kratom licences?
Not directly. Licences are issued by the Czech Ministry of Health. SÚKL provides an expert opinion within the licensing procedure.
What does the NPC do?
The National Drug Headquarters investigates criminal offences related to PML - mainly distribution without a licence, sale to minors and the forgery of licensing documents.
Who checks the content of a COA?
During the licensing procedure and batch control, COAs are assessed by SÚKL. At the market level, the ČOI may carry out verification sampling and compare it with the declared COA.
What is the difference between ČOI and SZPI?
The ČOI oversees trade in general (apart from food and medicines); the SZPI oversees food, feed and wine products. In the field of kratom the ČOI is primarily competent, while the SZPI comes in at the boundary with food regulation.
References
- Act No. 167/1998 Coll., on addictive substances, as amended.
- Act No. 2/1969 Coll., on the establishment of ministries and other central state-administration bodies of the Czech Republic.
- Act No. 378/2007 Coll., on pharmaceuticals (SÚKL's competence).
