What is Act No. 321 / 2024 Coll.?

Act No. 321 / 2024 Coll., amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, and other related laws — Act amending Act No. 167 / 1998 Coll., on addictive substances and amending some other laws, as amended, and other related laws.

When it became Act No. 321 / 2024 Coll. effectiveness?

Act No. 321 / 2024 Coll. became effective 01.01.2025.

Is Act No. 321 / 2024 Coll. still valid?

Yes, Act No. 321 / 2024 Coll. is still valid and effective.

How many times was it Act No. 321 / 2024 Coll. amended?

Act No. 321 / 2024 Coll. has 3 time versions of the text.

Act No. 321 / 2024 Coll. - Act amending Act No. 167 / 1998 Coll., o...

321

THE LAW

of 9 October 2024

amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, and other related laws

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

Amendment to the REC

Čl. I

Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., Act No. 117 / 2000 Coll., Act No. 132 / 2000 Coll., Act No. 57 / 2001 Coll., Act No. 185 / 2001 Coll., Act No. 135 / 2013 Coll., Act No. 140 / 2002 Coll., Act No. 140 / 2009 Coll., Act No. 141 / 2009 Coll., Act No. 167 / 2012 Coll., Act No. 50 / 2013 Coll., Act No. 135 / 2006 Coll., Act No. 74 / 2006 Coll., Act No. 106 / 2011 Coll., Act No. 341.

1. In Paragraph 1 (1), at the end of point (b), the word "a 'is replaced by a comma.

2. In Article 1, at the end of paragraph 1, the dot is replaced by "a 'and the following point (d) is added:

"(d) the treatment of psychomodulatory substances and psychoactive substances."

3. In Article 2, points (l) to (s) are added at the end of paragraph 1, including footnote 2h:

"(l) psychomodulatory substances of the new psychoactive substances 2h) and other substances having a psychoactive effect which do not pose a serious risk to public health or the risk of serious social impacts on individuals and society and are also listed in the Government Regulation on the list of psychomodulators and their products;

(m) the production of psychomodulatory substances for cleaning, sorting, processing, packaging and other treatment of psychomodulatory substances for marketing;

(n) the placing on the market of psychomodulators of any supply of psychomodulators to the final consumer;

(o) the distribution of psychomodulators to purchase them for resale and sale; the placing on the market of psychomodulators is not considered as distribution,

(p) by unit packaging of the psychomodulatory substance, the individual packaging of the psychomodulatory substance placed on the market;

(q) the import of psychomodulators by physical transfer to the Czech Republic;

(r) the export of psychomodulators by physical transfer outside the Czech Republic;

(s) classified psychoactive substances of new psychoactive substances which, in the light of scientific knowledge, cannot be excluded from serious health and social risks and are also listed in the Government Regulation on the list of classified psychoactive substances and products thereof.

(2h) Article 1 (4) of Council Framework Decision 2004 / 757 / JHA of 25 October 2004 laying down minimum provisions concerning the characteristics of offences and penalties in the field of illicit drug trafficking, as amended. '

4. In Section 8a, at the end of the text of paragraph 2, the words ", psychomodulatory substances or included psychoactive substances' shall be added.

5. In Part One, the following Title VII is inserted after Title VI, including the headings and footnotes 10m, 10p to 10zc:

„HLAVA VII

Psychomodulatory substances and classified psychoactive substances

Díl 1

Psychomodulatory agents

§ 33a

Management of psychomodulators

(1) Management of psychomodulatory substances means:

(a) research into psychomodulatory substances;

(b) the production, import and distribution of psychomodulatory substances;

(c) the purchase and placing on the market of psychomodulatory substances for the purpose of their placing on the market and the acquisition of other substantive and binding rights associated with them for that purpose, with the exception of placing on the market by means of distance communication;

(d) the purchase and placing on the market of psychomodulatory substances for the purpose of their placing on the market and the acquisition of other substantive and binding rights associated with them for that purpose,

(e) storage and transport of psychomodulatory substances for others, except storage and transport for the purpose of delivering psychomodulatory substances purchased by means of distance communication under the Law on the Protection of Health from the harmful effects of addictive substances to consumers;

(f) cultivation of plants or fungi from which psychomodulatory substances may be obtained.

(2) The treatment of psychomodulatory substances shall not be considered to be the cultivation and treatment of technical hemp plants and technical hemp referred to in Article 5 (5), or the treatment of hemp extract and tincture containing not more than 1% of the tetrahydrocaninol group for industrial, food, cosmetic, technical or horticultural purposes.

(3) The treatment of psychomodulatory substances is no longer considered

(a) the possession by natural persons of psychomodulatory substances for personal use;

(b) the use of natural persons with psychomodulatory substances in small quantities;

(c) the treatment of an accredited laboratory with psychomodulatory substances for the purpose of issuing a certificate pursuant to Article 33f (3);

(d) the treatment of psychomodulatory substances within the framework of the activities of state bodies within their respective fields of competence, the activities of local self-governing bodies within their delegation and the activities of local public order matters within their separate competences and activities of the Army of the Czech Republic, the Police of the Czech Republic, the General Inspection of Security Corps, the Prison Services of the Czech Republic and the Customs Administration of the Czech Republic in the performance of their tasks.

(4) The management of psychomodulatory substances referred to in paragraph 1 (a), (b), (c), (d) and (f) shall also mean the storage and transport of psychomodulatory substances related to these activities.

(5) The handling of psychomodulating substances other than those referred to in paragraphs 1 and 4 shall be prohibited.

§ 33b

Authorisation to handle psychomodulatory substances

The treatment of psychomodulatory substances requires authorisation, unless otherwise provided for in this law.

§ 33c

Issue of authorisations for the handling of psychomodulatory substances

(1) Authorisation for the disposal of psychomodulatory substances is issued by the Ministry of Health. The authorisation for disposal shall entitle the activities referred to therein only. The authorisation referred to in the first sentence shall be issued for an indefinite period.

(2) The authorisation to handle psychomodulatory substances is non-transferable.

(3) Authorisations for the disposal of psychomodulatory substances may be granted only to a legal person or to an undertaking of a natural person.

(4) An application for authorisation to handle psychomodulatory substances shall be made on a form issued by the Ministry of Health, the model of which shall be laid down in the implementing legislation. The application shall contain:

(a) the name, registered office, identification number of the person, if assigned, and the legal form, if any, of the legal person;

(b) the name or surname, the date of birth, the registered office and the identification number of the person, if assigned, if any, to the natural person involved;

(c) the list and description of the activities referred to in Article 33a (1) for which authorisation is sought by the applicant;

(d) the address of the establishment or premises where the psychomodulatory substances will be handled;

(e) the name and address of the website, the name of the application or other identifier of the electronic interface and a description of the verification system10m) and ensuring its functioning in the event of loading pursuant to § 33a (1) (d).

(5) The application referred to in paragraph 4 shall be accompanied by:

(a) proof of a business authorisation;

(b) the consent of the owner of the property to carry out the activities specified in the application, unless the applicant is the owner of the property,

(c) a research project with justification, a calculation of the research issues, a description of the methodology, analytical strategy and the implementation team of the research, in the case of an application for authorisation to dispose pursuant to Article 33a (1) (a);

(d) proof of payment of the fee for psychomodulatory substances under the Administrative Charges Act, with the exception of an application for authorisation to dispose of psychomodulatory substances under Paragraph 33a (1) (a);

(e) the proof of integrity referred to in Article 8a; Article 8a (4) shall apply mutatis mutandis.

(6) The Ministry of Health shall publish a list of persons handling psychomodulatory substances, including the data referred to in paragraph 4, on its website.

(7) The document referred to in paragraph 5 (a) is not required in the case of an application for authorisation to handle psychomodulatory substances pursuant to § 33a (1) (a) if the applicant is a high school (10p), a public research institution (10q) or a health service provider (10r).

(8) A legal person or an undertaking natural person handling psychomodulatory substances shall, without undue delay, notify the Ministry of Health of any changes and additions to the data referred to in paragraph 4 and the documents referred to in paragraph 5.

(9) The authorisation to handle psychomodulatory substances referred to in Article 33a (1) (d) may be granted only to a person holding a valid authorisation to handle psychomodulatory substances pursuant to Article 33a (1) (c).

(10) In the event that the applicant does not attach the document referred to in paragraph 5 (d) to the application, the procedure for the application for authorisation for the handling of psychomodulatory substances shall not be initiated and the Ministry of Health shall postpone the case by a resolution. The resolution shall only be recorded in the file. No degradation can be brought against the order. The applicant shall be informed of the order in an appropriate manner.

§ 33d

Repeal and withdrawal of authorisations for the handling of psychomodulatory substances

(1) If a legal person or an operating natural person ceases to engage in an activity for which it has been authorised to handle psychomodulatory substances, it shall notify the Ministry of Health without undue delay. The notification referred to in the first sentence shall be made on a form issued by the Ministry of Health, the model of which shall be laid down in the implementing legislation.

(2) The Ministry of Health will decide to revoke the authorisation to handle psychomodulatory substances

(a) in the cases referred to in paragraph 1; or

(b) at the request of a legal person or an undertaking natural person authorised to handle psychomodulatory substances; a request for revocation of the authorisation for the handling of psychomodulatory substances shall be made on a form issued by the Ministry of Health, the model of which shall be laid down in the implementing legislation.

(3) The Ministry of Health will decide on the withdrawal of authorisations for the handling of psychomodulatory substances,

(a) where a legal person or an operating natural person has been definitively convicted of an offence the facts of which relate to the treatment of psychomodulatory substances or psychoactive substances included;

(b) if the maintenance fee is not paid under the Administrative Charges Act.

(4) In addition, the Ministry of Health may decide to withdraw authorisations for the handling of psychomodulatory substances,

(a) if he finds that the legal person or the undertaking natural person has provided false or incomplete information in the application;

(b) where a legal person or an operating natural person, when dealing with psychomodulatory substances, infringes the obligation laid down by this law and has been fined for that breach;

(c) where a legal person or a natural person engaged in the treatment of psychomodulatory substances has committed an infringement of the law on the protection of health against the harmful effects of addiction10s) and has been fined for that breach.

(5) A new authorisation for the treatment of psychomodulators may be granted to a person who has been withdrawn from the authorisation for the treatment of psychomodulatory substances referred to in paragraph 3 or 4 at the earliest two years after the date on which the decision to withdraw the authorisation for the treatment of psychomodulatory substances became final. This shall apply mutatis mutandis to a legal person whose statutory authority is the person who was the statutory authority of the holder of the authorisation for disposal at the time when the authorisation for disposal was withdrawn.

(6) If the Ministry of Health decides to withdraw the authorisation to dispose of psychomodulatory substances or, by its decision, to revoke the authorisation to dispose of psychomodulatory substances, it shall specify in the decision the time limit for carrying out the closure operations and the way in which the psychomodulatory substances are to be handled.

§ 33e

Labelling of psychomodulators

(1) The manufacturer or distributor of psychomodulators must ensure that the following information is provided on the unit packaging and outer packaging of psychomodulators in accordance with the implementing legislation:

(a) the text "Psychomodulatory substance,"

(b) the name of the psychomodulation agent;

(c) the subtype and form of the psychomodulatory substance;

(d) name of active substances;

(e) the net quantity of psychomodulatory substance per unit pack;

(f) the net quantity of active substances per unit pack,

(g) the name or name and surname, or the name or business name and address of the manufacturer's or the manufacturer's registered office;

(h) the country of origin;

(i) the date of manufacture;

(j) the indication of the lot,

(k) the date of minimum durability,

(l) consumer information communication on effects and risks;

(m) information on the recommended dosage,

(n) safety warnings on the hazard of use by minors;

(o) health warnings;

(p) information on the presence of substances that may cause allergy or intolerance in certain persons.

(2) The detailed definition of the data referred to in paragraph 1 shall be laid down in implementing legislation.

(3) Lot means the quantity of species-identical individual packages of psychomodulatory substances which have been manufactured under the same conditions in the same way from the same raw material and at the same time.

(4) The consumer information message, the safety warning on the risk of the use of the product by minors and health warnings are text and graphic information provided for in the implementing legislation.

(5) The information on the packaging must not encourage the risk of using a psychomodulatory substance.

(6) Without the designation referred to in paragraph 1, psychomodulation substances may not be placed on the market.

(7) A person who places psychomodulatory substances on the market by means of means of distance communication shall, when offering psychomodulatory substances to the consumer, provide the data referred to in points (a) to (h) and (l) to (p) of paragraph 1 before the purchase is completed and indicate them in the material supporting distance selling or by other appropriate means; in the case of use of other means, mandatory information on psychomodulatory substances shall be provided to the consumer free of charge and any mandatory information shall be made available to the consumer at the time of delivery.

§ 33f

Production, distribution and marketing of psychomodulators

(1) The manufacturer of psychomodulators is obliged to comply with good manufacturing practice at all stages of production. The requirements for good manufacturing practice shall be laid down in implementing legislation.

(2) The manufacturer or distributor of psychomodulators shall verify that the batch of psychomodulators placed on the market complies with the requirements for the maximum concentration of active substances in the psychomodulators and the maximum permitted chemical and microbiological contamination.

(3) Certificates of verification of compliance with the obligations referred to in paragraph 2 shall be issued by an accredited laboratory. Without this certificate, the lot may not be marketed.

(4) An accredited laboratory is for the purposes of this Act a laboratory which, according to the Czech technical standard governing the competence of testing and calibration laboratories 10t) is accredited to carry out these examinations by an accreditation body under the conformity assessment law 10t). The scope of the accreditation of the laboratory shall include laboratory analytical, testing or diagnostic methods used by the laboratory to demonstrate compliance with the requirements referred to in paragraph 2.

(5) The manufacturer, distributor or person who places psychomodulatory substances on the market is required to:

(a) to use only packaging and packaging materials which protect the product from deterioration, prevent confusion or change of content without opening or changing the packaging;

(b) in the case of psychomodulatory substances intended for oral use, use only those packages which meet the requirements for articles and materials intended to come into contact with food (10v);

(c) to place or supply for marketing psychomodulatory substances exclusively in unit packaging;

(d) immediately remove from the further marketing or marketing of psychomodulatory substances

1. packed in packs which do not comply with the requirements for articles and materials intended to come into contact with food or packaging which do not protect psychomodulatory substances from degradation (10w), 10x),

2. insufficiently or incorrectly marked; or

3. odorous, if odour is not a characteristic of the product, or damaged, deformed, contaminated or manifestly chemically or microbiologically disturbed.

(6) It shall be prohibited to place or supply psychomodulatory substances which:

(a) are deluded or offered in a misleading manner;

(b) remind their appearance of confectionery, chocolate or chocolate chocolates (10y), biscuits or durable pastries (10z), or other foodstuffs,

(c) remind themselves of a toy or a product intended for children;

(d) are of unknown origin,

(e) contain tobacco, nicotine, nicotine salts, narcotic and psychotropic substances or other psychomodulatory substances;

(f) contain caffeine, taurine or other stimulating ingredients;

(g) exceed the maximum authorised level of the psychomodulation substance or the maximum authorised level of the active substance in the unit pack or exceed the maximum authorised concentration of the active substance; or

(h) may cause damage to health due to contamination.

(7) Furthermore, it is prohibited to:

(a) provide free or other benefits in the form of goods or services in connection with the sale of psychomodulators;

(b) provide free or other benefits in the form of psychomodulatory substances in connection with the sale of goods or services.

(8) The implementing act lays down the technical requirements for the composition, appearance, quality and properties of psychomodulators including the maximum authorised amount of psychomodulatory substance in a unit pack, the maximum authorised quantity of active substances in a unit pack, the maximum authorised concentration of active substances, the prohibited elements and features when placing the psychomodulators on the market and the requirements for maximum authorised chemical and microbiological contamination.

§ 33g

Import and export of psychomodulators

(1) Imports of psychomodulatory substances are allowed only to the person who has been authorised to dispose of the products under Paragraph 33a (1) (b).

(2) The export of psychomodulating substances outside the Czech Republic is prohibited, except for exports by a natural person in small quantities for personal use.

(3) In the event that the State from which the import is to be made requires an importer to obtain an import authorisation issued by the Czech Republic, the Ministry of Health shall issue a certificate to the importer that no import authorisation is required for the import of a psychomodulation substance into the Czech Republic.

(4) Paragraph 23 shall apply mutatis mutandis to transit operations with psychomodulators.

§ 33h

Registration of psychomodulating substances and annual reporting

(1) A person handling psychomodulatory substances pursuant to Article 33a (1) shall keep a register of the handling of psychomodulatory substances.

(2) The person referred to in paragraph 1 shall, before the end of February, forward to the Ministry of Health reports on the production, cultivation, distribution, purchase, sale, import of psychomodulators and the state and movement of their stocks for the previous calendar year.

(3) The formalities and contents of the register, the storage and verification method and the model of the reporting form referred to in paragraph 2 shall be laid down in the implementing legislation.

Díl 2

Classification of psychoactive substances

§ 33i

Classification of new psychoactive substances

(1) The Ministry of Health, in cooperation with the State Health Institute and the Government of the Czech Republic (hereinafter the Office), on the basis of its own findings or on the basis of cooperation within the European Union's early warning system in the field of new psychoactive substances, will propose to the Government the inclusion of a new psychoactive substance in the list of listed psychoactive substances or in the list of addictive substances.

(2) The proposal referred to in paragraph 1 shall include a rapid evaluation of the new psychoactive substance for which the provisions of Paragraph 33k (2) shall apply mutatis mutandis.

§ 33j

Treatment of classified psychoactive substances

(1) Treatment of psychoactive substances is understood as

(a) research on classified psychoactive substances;

(b) the production, export, import and distribution of listed psychoactive substances, the purchase of listed psychoactive substances for the purpose of their marketing and marketing, as well as the acquisition of other substantive and binding rights associated with them for that purpose, and their marketing.

(2) Treatment of classified psychoactive substances shall not be considered as

(a) the possession by natural persons of classified psychoactive substances in small quantities for personal use;

(b) the treatment of psychoactive substances included within the scope of the activities of the national authorities within their competence, the activities of the local authorities within their delegation and the activities of the local public order matters in their separate competence and the activities of the Army of the Czech Republic, the Police of the Czech Republic, the General Inspection of Security Corps, the Prison Services of the Czech Republic and the Customs Administration of the Czech Republic in the performance of their tasks.

(3) The treatment of classified psychoactive substances other than those referred to in paragraph 1 (a) shall be prohibited.

(4) A legal person or an undertaking natural person intending to dispose of classified psychoactive substances for research purposes shall be required to apply to the Ministry of Health for authorisation to dispose of classified psychoactive substances. The provisions of Sections 33a (4), 33c, 33d (1) and (2), 33d (3) (a) and 33d (4) to (6) shall apply mutatis mutandis to authorisations for the treatment of classified psychoactive substances.

(5) Paragraph 33h shall apply mutatis mutandis to the registration of the treatment of classified psychoactive substances.

§ 33k

Evaluation of classified psychoactive substances, psychomodulators and addictive substances

(1) If a substance has been included in the list of classified psychoactive substances, the Ministry of Health shall, in cooperation with the State Health Institute and the Authority, carry out a risk assessment of the listed psychoactive substance and after its termination, but no later than 2 years after the inclusion of the substance in the list of classified psychoactive substances, propose to the Government the inclusion of that substance in the list of psychomodulatory substances or on the list of addictive substances or propose that the substance remain on the list of classified psychoactive substances or be excluded from that list.

(2) In the evaluation referred to in paragraph 1, the Ministry of Health, in cooperation with the State Health Institute and the Office, shall examine in particular:

(a) the pharmacological and toxicological properties of the substance;

(b) the degree and nature of the psychoactivity of the substance;

(c) the potential of the substance to cause dependence;

(d) the potential of the substance to cause health or social damage;

(e) information on the supply, manufacture, import, export and market of a substance for human consumption or for other purposes, in particular whether the substance is a food under Regulation No 178 / 200210za of the European Parliament and of the Council) or a medicinal product under the Law on Medicinal Products (e),

(f) information on the occurrence of use and the occurrence of intoxication, death and other health and social consequences of use of the substance;

(g) evaluation and recommendations of international organisations and institutions of the European Union10zb).

(3) On the basis of the new findings, the Ministry of Health, in cooperation with the State Health Institute and the Authority, will re-evaluate the risks of the listed psychoactive substance or substance that has been included in the list of psychomodulators or substance addicts, including repeatedly.

(4) After each evaluation referred to in paragraph 3, the Ministry of Health, in cooperation with the State Health Institute and the Authority, shall propose that the Government include a substance on the list of classified psychoactive substances or on the list of psychomodulatory substances or addictive substances, while excluding the substance from the list in which it was already listed, except where the outcome of the evaluation referred to in paragraph 3 is that the substance should not be included in a list other than that in which it is included.

(5) If a substance included in the list of classified psychoactive substances, the list of psychomodulators or the list of addictive substances is included in the Union list of new authorised foods under the Regulation of the European Parliament and of the Council on Novel Foods10zc), the Ministry of Health, in cooperation with the State Health Institute and the Authority, will propose to the Government the exclusion of a substance from the list of classified psychoactive substances, a list of psychomodulators or a list of addictive substances.

(6) The list of classified psychoactive substances and the list of psychomodulators are laid down in implementing legislation.

10m) § 3 of Act No. 250 / 2017 Coll., on Electronic Identification.

10p) Act No. 111 / 1998 Coll., on higher education institutions and amending and supplementing other laws (Act on higher education), as amended.

10q) Act No. 341 / 2005 Coll., on Public Research Institutions, as amended.

10r) Act No. 372 / 2011 Coll., on health services and the conditions of their provision (Health Services Act), as amended.

10s) Act No. 65 / 2017 Coll., on the protection of health against harmful effects of addicts, as amended.

10t) ČSN EN ISO / IEC 17025 General requirements for the competence of test and calibration laboratories.

10u) Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the amendment and addition of certain laws, as amended.

10v) Decree of the Ministry of Health No. 38 / 2001 Coll., on sanitary requirements for food and food contact products, as amended.

10w) Regulation (EC) No 1935 / 2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80 / 590 / EEC and 89 / 109 / EEC, as amended.

10x) Paragraph 26 (5) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended.

10y) Decree No. 76 / 2003 Coll., laying down requirements for natural sweeteners, honey, confectionery, cocoa powder and cocoa blends with sugar, chocolate and chocolate sweets, as amended.

10z) Decree No. 18 / 2020 Coll., on requirements for grain mill products, pasta, bakery and pastry products and dough.

10za) Regulation (EU) No 178 / 2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

10zb) Directive (EU) 2017 / 2103 of the European Parliament and of the Council of 15 November 2017 amending Council Framework Decision 2004 / 757 / JHA in order to include new psychoactive substances in the definition of drugs and repealing Council Decision 2005 / 387 / JHA. Regulation (EU) 2023 / 1322 of the European Parliament and of the Council of 27 June 2023 on the European Union Agency for Drugs (EUDA) and repealing Regulation (EC) No 1920 / 2006 as regards the exchange of information on new psychoactive substances, the early warning system and the risk assessment procedure.

Citation	Act No. 321 / 2024 Coll., amending Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended, and other related laws
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	07.11.2024
Effective from	01.01.2025
Effective until	-
Status	Valid

Act No. 321 / 2024 Coll.

Act amending Act No. 167 / 1998 Coll., on addictive substances and amending some other laws, as amended, and other related laws

Contents