Decree No. 147 / 2025 Coll.
Order on forms and records of psychomodulatory substances and included psychoactive substances
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Effective from 06.06.2025
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147
DECLARATION
of 16 May 2025
on forms and records of psychomodulatory substances and included psychoactive substances
According to Section 44c (6) for the implementation of § 33c (4), § 33d (1), § 33d (2) (b), § 33h (3) and § 33j (4) of Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 321 / 2024 Coll., (hereinafter "the Act '):
Subject matter
(1) This order provides for a model form
(a) applications for authorisation to handle psychomodulatory substances pursuant to Section 33c (4) of the Act in Annex 1 to this Decree;
(b) applications for authorisation to dispose of classified psychoactive substances pursuant to § 33j (4) of the Act in conjunction with § 33c (4) of the Act in Annex 2 to this Decree;
(c) notification of cessation of activities with psychomodulatory substances pursuant to Article 33d (1) of the Act in Annex 3 to this Decree;
(d) notification of cessation of activity with classified psychoactive substances pursuant to § 33j (4) in conjunction with § 33d (1) of the Act in Annex 4 to this Decree;
(e) an application for revocation of the authorisation for the handling of psychomodulatory substances pursuant to Article 33d (2) (b) of the Act in Annex 5 to this Decree;
(f) applications for the cancellation of authorisations for the treatment of classified psychoactive substances pursuant to § 33j (4) of the Act in conjunction with § 33d (2) (b) of the Act in Annex 6 to this Decree;
(g) annual reports of psychomodulatory substances pursuant to § 33h (2) of the Act in conjunction with § 33h (3) of the Act in Annex 7 to this Decree; and
(h) annual reports of classified psychoactive substances pursuant to § 33h (2) of the Act in conjunction with § 33h (3) of the Act and § 33j (4) of the Act in Annex 8 thereto.
(2) This decree also provides for the particulars and content of the registration of the use of:
(a) with psychomodulatory substances, the way in which it is stored and verified under Section 33h (3) of the Act; and
(b) the classification of psychoactive substances, the method of its storage and verification pursuant to Article 33j (4) of the Act in conjunction with Article 33h (3) of the Act.
Registration requirements
(1) Records of the handling of psychomodulatory substances shall be kept only in electronic form ("electronic records"). This does not apply to research where it is possible to keep records of the handling of psychomodulatory substances in the register. The registration book is a register kept in paper form in bound books with numbered sheets.
(2) Records of the treatment of classified psychoactive substances are kept in the register.
(3) Records of the handling of psychomodulatory substances and of the handling of classified psychoactive substances shall always be kept in such a way as to show the facts which are the subject of them. The compliance of the records with the actual situation shall be verified by inventory.
(4) Psychomodulatory substances shall be recorded under the name given in the legislation on the list of psychomodulatory substances (1), in the case of a psychomodulatory substance in the form of a product intended to be placed on the market by the name, form and sub-type mentioned in the legislation on psychomodulatory substances (2) and the size of the unit packaging.
(5) Classification of psychoactive substances is to be recorded under the name given in the legislation amending the list of psychoactive substances included (3).
Registration book
(1) The ledger, apart from its own records pursuant to § 7 and 13, always contains:
(a) the name and, where applicable, the name and surname of the person holding the register of the treatment of psychomodulatory substances or the registration of the treatment of classified psychoactive substances, including the name and address of the establishment where the activity is actually carried out with the substance which is the subject of the registration of the treatment of psychomodulatory substances or of the treatment of classified psychoactive substances under the law and this decree, where the address of that establishment is different from that of the registered office;
(c) the name and, where applicable, the names of the natural person entering the records, his address of the place of permanent residence and, if he does not have a permanent residence, his address of residence, his signature (hereinafter referred to as "signature") and the date on which the registration is carried out,
(d) the date of transmission of the register for use and termination of use;
(e) information on the total number of sheets, indicating the number of the first and the last sheets; and
(f) a list of registered psychomodulators or included psychoactive substances, indicating the number of sheets reserved for the registration of individual substances.
(2) Registration books may be kept separately for the various branches of legal entities.
(3) The records shall be entered in the records on the date on which the recorded event, water, solvent and sun-resistant ink occurred and signed by the person making the entry.
(4) Corrections to the records shall be made in such a way as to determine the contents of the original record. The corrected alert shall be dated and signed by the person who corrected the alert.
(5) The ledger shall be kept in such a way as to prevent it from being degraded, lost, damaged, destroyed, misused or stolen for a period of 5 years from the last entry in it; the registration book shall be kept for the person whose identification details have been communicated by the Ministry of Health in the form set out in Annex 3, 4, 5 or 6 to this Order on completion of the activity and when the authorisation for disposal is revoked.
Electronic registration
(1) Electronic records shall be kept in such a way as to allow for separate daily monitoring of movements and stocks and their traceability for 5 years.
(2) Corrections to the records shall be made in such a way as to determine the contents of the original record. The corrected alert shall be dated and signed by the person who corrected the alert.
(3) In the case of electronic records, it shall be ensured that only persons authorised to do so carry out entries in the register of the handling of psychomodulatory substances, ensuring that each entry is accompanied by a recognised electronic signature.
(4) Electronic records must be kept separately for each organisational component and for each activity.
(5) Records shall be entered in the electronic register on the date on which the recorded event occurred.
(6) In the case of electronic records, it is necessary to ensure that records of the handling of psychomodulatory substances allow the immediate single electronic output in the .xml format to be carried out at any premises by persons handling psychomodulatory substances, which correctly depicts all the facts required by this decree during the reference period. At the same time, it is necessary to ensure that records of the handling of psychomodulatory substances allow a uniform print output.
Electronic record keeping
(1) When keeping electronic records, the person handling psychomodulatory substances shall keep data media containing data pursuant to § 8, 9, 10, 11 or 12 following the registered activity in such a way as to prevent them from being degraded, lost, damaged, destroyed, misused or stolen for a period of 5 years from the last entry in them. The person handling psychomodulatory substances shall ensure regular backup of data from which the data kept in the records on the handling of psychomodulatory substances can be reconstructed. In addition, this person shall ensure the backup of data on media different from the hardware equipment used to keep electronic records, for a period of 5 years from the last record in them. Backup shall be carried out according to a predetermined schedule by the person handling the psychomodulatory substances, but always without undue delay after the closure of the operating day.
(2) A person handling psychomodulatory substances shall draw up and maintain internal rules for the organisational and technical security of electronic registration in writing, setting out at least:
(a) conditions for access by users to the electronic record-keeping system, the scope of access rights and the setting-up process, including how to decide on the scope of access rights of individual users and decide on their changes;
(b) the procedure and timing of the data backup referred to in paragraph 1;
(c) the procedure for the reconstruction of data kept in the electronic register from backup data;
(d) the way documents are kept;
(e) a procedure for dealing with situations where the functions of the electronic registration system are malfunctioning, including the way in which the replacement operation is ensured;
(f) a procedure for dealing with a situation where the means used to keep electronic records under contract with another person cannot continue to be used;
(g) the procedure for correcting errors in the electronic record and the content of the record of the correction made, including the traceability of the original record; and
(h) the manner in which users are trained and the way in which documentation of the training carried out is kept.
(3) The person handling the psychomodulatory substances shall keep a record of cases where the functions of the electronic registration system have failed ("malfunction records'). The system malfunction shall be entered in the fault log no later than 14 days after the date on which the failure occurred. In addition to the requirements set out in Sections 3 (1) (a) to (d), 3 (4) and 3 (5), fault records shall contain:
(a) item number,
(b) the date of system failure;
(c) a description of the system failure;
(d) a description of the solution to the situation;
(e) the signature of the person making the entry; and
(f) the date on which the registration was made.
Inventory
(1) The inventory, both in the register and in the electronic record, is carried out on the last day of the calendar quarter (hereinafter referred to as the quarterly inventory), even if no movement record has been recorded during the calendar quarter. If the last day of the calendar month is Saturday, Sunday or holiday and there is no recorded fact in the meantime, the quarterly inventory may be made on the next working day.
(2) A record shall be made of the quarterly inventory, which shall be drawn up in paper form and shall include the following particulars for all items monitored:
(a) the initial state of the reference period;
(b) total revenue,
(c) total output; and
(d) the situation at the last day of the calendar quarter.
(3) In addition, the inventory record shall include the date, name or names, as appropriate, and the surname, function and signature of the person making the inventory.
(4) If no movement has occurred during the reference period, the quarterly inventory record shall include:
(a) the words "Status unchanged,"
(b) the date of the inventory; and
(c) signatures of the persons carrying out the inventory.
(5) If the inventory identifies the difference between the actual and the record state, an inventory report shall be drawn up indicating the differences identified, their justification, the date, name, function and signature of the person making the inventory, including the person authorised to act for the person handling the psychomodulatory substances or for the person handling the classified psychoactive substances.
Evidence of psychomodulatory research
(1) For keeping records of the handling of psychomodulatory substances in research, the register or electronic record shall state the name of the project or the objective of the research activity. A separate register shall be kept for each research project or objective or records shall be kept separately in electronic records.
(2) The register or electronic records referred to in paragraph 1 shall contain the following records:
(a) the name of the psychomodulation agent;
(b) the name of a substance which is not a psychomodulatory substance but will be used for research into the manufacture of a psychomodulatory substance;
(c) the serial number of the registration;
(d) the date of use of a psychomodulatory substance or a substance which is not a psychomodulatory substance but will be used for research into the manufacture of a psychomodulatory substance as the main feedstock, the treatment of which results from a psychomodulatory substance;
(e) the quantity of psychomodulatory or non-psychomodulatory substance used but will be used for research into the manufacture of the psychomodulatory substance as the main input material, the treatment of which results from the psychomodulatory substance;
(f) the test number or other identification of the psychomodulatory substance generated;
(g) the method of consumption of a psychomodulatory substance or a substance which is not a psychomodulatory substance but will be used for research into the manufacture of a psychomodulatory substance as the main feedstock resulting from the modification of a psychomodulatory substance; and
(h) the name and, where applicable, the names and surname, capacity and signature of the official carrying out the registration in the register or of the recognised electronic signature of the official making the registration in the electronic register.
Registration in the manufacture of psychomodulators
(1) In the manufacture of psychomodulatory substances, electronic records shall be kept of all production activities occurring during manufacture.
(2) The electronic registration in the manufacture of psychomodulatory substances contains the following records:
(a) the name of the psychomodulation substance, including its form and subtype;
(b) the name of the product intended for placing on the market and the size of the unit pack when the output of the unit pack is,
(c) the name of a substance which is not a psychomodulatory substance but is the main feedstock for its production and the modification of which produces a psychomodulatory substance;
(d) the serial number of the registration;
(e) the date on which the psychomodulatory substance is taken from the warehouse;
(f) the date on which a substance which is not a psychomodulatory substance is taken over but is the main input material for its production and the treatment of which results in a psychomodulatory substance from a warehouse;
(g) the quantity of psychomodulatory substance in grams or in the number of packages taken from storage;
(h) the quantity of a substance which is not a psychomodulatory substance but is the main feedstock for its production and the treatment of which produces a psychomodulatory substance in grams;
(i) the production batch number,
(j) the date of transmission of finished psychomodulatory substances to the warehouse in grams or in number of unit packages;
(k) the quantity of finished psychomodulators delivered to the warehouse in grams or per unit pack,
(l) a record of the verification carried out pursuant to Article 33f (2) of the Act which contains the identification of the accredited laboratories used and the identification of the certificate referred to in Article 33f (2) of the Act;
(m) actual production losses in grams;
(n) waste resulting from production in grams;
(o) the recognised electronic signature of the person making the registration; and
(p) identification of the certificate pursuant to Article 33f (2) of the Act.
Registration for the distribution of psychomodulators
The electronic registration for the distribution of psychomodulators shall contain the following entries:
(a) the name of the psychomodulation substance, including its form and subtype;
(b) the name of the product intended for placing on the market and the size of the unit pack;
(c) the date of receipt;
(d) the date of issue;
(e) the number of the receipt document;
(f) the number of the proof of issue;
(g) the lot number,
(h) the name and, where appropriate, the names and surname or registered office of the supplier;
(i) the quantity accepted;
(j) the quantity issued;
(k) unit quantity,
(l) stocks,
(m) identification of the certificate pursuant to Article 33f (2) of the Act; and
(n) the recognised electronic signature of the person making the registration.
Registration when marketing psychomodulators
The electronic registration for the placing on the market of psychomodulators shall include the following records:
(a) the name, subtype and form and size of the unit packaging of a psychomodulatory substance intended for placing on the market;
(b) the date of receipt;
(c) the date of issue;
(d) the number of the receipt document;
(e) the number of the proof of issue,
(f) the lot number,
(g) the name and, where applicable, the names and surname or registered office of the supplier;
(h) the quantity accepted;
(i) the quantity issued;
(j) unit of quantity,
(k) stocks, and
(l) the recognised electronic signature of the person making the registration.
Registration of plants or fungi from which psychomodulatory substances are to be produced
Electronic records for growing plants or fungi from which psychomodulatory substances are to be produced shall include the following records:
(a) the name of the source plant or fungus;
(b) botanical name,
(c) the quantities of plants or mushrooms grown in pieces;
(d) the quantities of plants or mushrooms received, in pieces, when acquired from another grower;
(e) the name and, where appropriate, the names and the name or address of the grower, if the plants or mushrooms have been acquired from another grower;
(f) the date of acceptance of the plants or fungi, when acquired from another grower;
(g) the quantities of plants or mushrooms grown in pieces;
(h) the quantities of plants or fungi issued in pieces, if they have been issued to another breeder;
(i) the name and, where appropriate, the names and the name or address of the grower, if the plants or mushrooms have been issued to another grower;
(j) the date of issue of the plants or fungi, if they have been issued to another breeder;
(k) the serial number of the registration;
(l) the date of registration of the quantity of psychomodulatory substance produced;
(m) the name of the psychomodulation substance produced;
(n) the quantity of psychomodulatory substance produced,
(o) unit of quantity of psychomodulatory substance produced;
(p) the amount of waste from the cultivated plant or fungus; and
(q) the recognised electronic signature of the person making the registration.
Registration during storage and transport of psychomodulators
Electronic storage and transport records for psychomodulatory substances shall contain the following records:
(a) the name of the psychomodulation substance, including its form and subtype;
(b) the name and package size of the psychomodulatory substance in the case of unit packaging;
(c) the date of receipt;
(d) the date of issue;
(e) the number of the receipt document;
(f) the number of the proof of issue;
(g) the lot number,
(h) the name and, where appropriate, the names and surname or registered office of the supplier;
(i) the name and, where applicable, the names and surname or registered office of the buyer;
(j) the quantity accepted;
(k) the quantity issued,
(l) unit of quantity,
(m) stocks, and
(n) the recognised electronic signature of the person making the registration.
Registration of classified psychoactive substances
(1) For keeping records of the treatment of classified psychoactive substances in research, the register shall state the name of the project or objective of the research activity. A separate register shall be kept for each research project or objective.
(2) The register referred to in paragraph 1 shall contain the following records:
(a) the name of the classified psychoactive substance;
(b) the name of a substance which is not a classified psychoactive substance but which will be used for research into the production of a classified psychoactive substance as the main feedstock, the treatment of which results from the classified psychoactive substance;
(c) the serial number of the registration;
(d) the name and, where appropriate, the names of the supplier, and the name or address of the supplier;
(e) the date of receipt;
(f) the quantity accepted;
(g) the date of use of the classified psychoactive substance or substance which is not a classified psychoactive substance but will be used for research into the production of the classified psychoactive substance as the main feedstock, the treatment of which results from the classified psychoactive substance;
(h) the quantity of the classified psychoactive substance or substance used, which is not a classified psychoactive substance but will be used for research into the production of the classified psychoactive substance as the main feedstock, the treatment of which results from the classified psychoactive substance;
(i) the test number or other identification of the classified psychoactive substance;
(j) the method of consumption of the classified psychoactive substance or substance which is not a classified psychoactive substance but will be used for research into the production of the classified psychoactive substance as the main feedstock, the treatment of which results from the classified psychoactive substance;
(k) stocks, and
(l) the name and, where appropriate, the names and surname, function and signature of the official carrying out the registration.
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Regulation Information
| Citation | Decree No. 147 / 2025 Coll., on forms and records of psychomodulatory substances and included psychoactive substances |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 22.05.2025 |
|---|---|
| Effective from | 06.06.2025 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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