In brief
From 1 January 2026, the distribution of psychomodulatory substances (PML), and thus of kratom, requires a licence to handle PML issued by the Czech Ministry of Health. The legal basis is provided by Sections 3 and 5 of Act No. 167/1998 Coll., on addictive substances, as amended; the technical and procedural details are governed by an implementing decree effective from 1 July 2026.
What the PML handling licence is
A licence to handle PML is an administrative authorisation that entitles the holder to one or more of the following activities:
- import of PML into the Czech Republic,
- export of PML from the Czech Republic,
- wholesale distribution within the Czech Republic,
- retail sale to the end consumer,
- manufacture of preparations containing PML.
The licence may be granted for one of these activities or for a combination of them. An entity may apply for a so-called limited licence for a specific scope of activities (e.g. retail only, without the right to import).
Who issues the licence
The licence is issued by the Czech Ministry of Health on the basis of an application. Other authorities also give their opinion in the procedure:
- the State Institute for Drug Control (SÚKL) - an expert opinion on the safety requirements,
- the Public Health Authority - a check of the storage conditions,
- the National Drug Headquarters of the Czech Police - a security screening of the applicant.
The specific procedural deadlines and requirements are governed by an implementing decree.
Conditions for obtaining it
The law sets the following general conditions for obtaining a PML licence:
The applicant (a legal or natural person)
- proof of the good standing of the statutory body and the responsible person,
- a document of the professional competence of the responsible person,
- proof of the absence of tax arrears.
Storage premises
- a lockable storage space with access records,
- temperature and humidity control for storing PML,
- separation from other products (especially for wholesale).
Records
- keeping batch records of receipts, issues and stock,
- retaining certificates of analysis (COA) for each batch,
- archiving the documentation for at least 5 years.
Responsible person
The law requires that every licence holder have a designated responsible person with professional education (typically pharmaceutical, chemical or related) and experience in the field. This person is responsible for compliance with the law within the organisation.
Sanctions for unauthorised distribution
Distribution of PML without a valid licence is, under the law:
- a criminal offence under Section 283 of Act No. 40/2009 Coll., the Criminal Code, as amended by the 2025 amendment which added PML to the definition of the offence; the sanction is imprisonment, a monetary penalty, forfeiture of the item and a ban on the activity,
- accompanied by an administrative sanction imposing a fine on the persons involved in the unauthorised distribution.
For existing sellers who, at the time the amendment takes effect (1 January 2026), already trade in kratom, the law provides a transitional period for obtaining a licence; the specific length of the period is governed by an implementing decree.
Frequently asked questions
Does an e-shop also need a licence?
Yes. The law does not distinguish the form of distribution - a licence is required for every sale of PML, including online sale. In addition, an e-shop must meet the special requirements for 18+ age verification.
What is a "limited licence"?
A limited licence is a licence issued only for a specific scope of activities (e.g. retail but not import). The applicant can define which activities they wish to carry out, and the licence is issued only for those.
Do the licences for import and for sale differ?
Yes. The import of PML has a separate regime that, in addition to the licence, requires notification of each individual consignment and cooperation with the Customs Administration. Sale (wholesale and retail) has its own procedural rules.
Can the licence be transferred to another entity?
The licence is not transferable. On a change of legal form or the sale of the business, the new entity must submit a separate application.
References
- Sections 3 and 5 of Act No. 167/1998 Coll., on addictive substances, as amended.
- Section 283 of Act No. 40/2009 Coll., the Criminal Code, as amended (2025 amendment).
- Explanatory memorandum to the amendment of Act No. 167/1998 Coll. (Chamber of Deputies of the Parliament of the Czech Republic, 2025).
