Act No. 272 / 2013 Coll.

Law on drug precursors

Valid Law Effective from 01.01.2014
272
THE LAW
of 22 August 2013
on drug precursors
Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

INTRODUCTORY PROVISIONS
§ 1
Subject matter
This law regulates following directly applicable European Union1)
(a) certain obligations of commercial natural persons, legal persons and government bodies which are engaged or intend to deal with the substance category 1, 2 or 3, with the non-scheduled substance, or with the source or auxiliary substance ("drug precursor");
(b) the competence of the administrative authorities in the exercise of public administration under the directly applicable European Union rules governing drug precursors (1) and this law;
(c) carrying out checks on compliance with the obligations laid down in the directly applicable provisions of the European Union governing drug precursors (1) and this law; and
(d) administrative penalties for infringements of the obligations laid down in the directly applicable provisions of the European Union governing drug precursors (1) and this law.

ČÁST DRUHÁ

LICENCE AND REGISTRATION

HLAVA I

LICENCES FOR ACTIVITIES WITH ADDED CATEGORIES 1
§ 2
Licence application and special licence application
(1) Entrepreneurial natural persons, legal persons and public administrations intending to operate with that substance of category 1 under the directly applicable European Union1) are required to submit to the Ministry of Health (hereinafter referred to as "Ministry") a licence application or a special licence application (2) on a form the model of which is laid down in the implementing legislation and to attach to the application:
(a) proof of appointment of the responsible person in accordance with the provisions directly applicable to the European Union3);
(b) proof of the employment or service relationship of the person responsible pursuant to Article 11 (1);
(c) evidence of medical fitness of the responsible person in accordance with Article 11 (3);
(d) evidence of professional competence of the responsible person pursuant to Article 11 (4);
(e) a decision proving a manufacturing authorisation under the Drug Act when a licence is applied for to operate with that category 1 substance for the purpose of producing a medicinal product or active substance, or for distribution under the Drug Act when a licence is applied for to operate with that category 1 substance for the purpose of distributing the active substance; and
(f) a description of the technology of the intended manufacture when a licence is applied for for for the manufacture of that category 1 substance.
The documents referred to in points (b) to (f) shall not be attached to the application for a special licence.
(2) A special licence is issued by the medical care provider, the Customs Administration of the Czech Republic, the Police of the Czech Republic, the Military Police, the Prison Service of the Czech Republic, the General Inspection of the Security Corps and the Army of the Czech Republic.
§ 3
Application for amendment or renewal of a licence or special licence
(1) An application for a new licence or a special licence, on the basis of a change in the information provided for in the licence or a special licence pursuant to the directly applicable European Union4) and an application for an extension of a licence or a special licence, are required to be made by the natural persons, legal persons and public authorities on a form the model of which is laid down in the implementing legislation and an application to attach the annexes referred to in Article 2 (1), except for those annexes which have already been attached to earlier licence applications or special licences and for which no change was made at the date of the application; This fact shall be supported by a declaration of honour by the natural persons, legal persons and administrative bodies involved.
(2) Where there is a change in the person responsible, a change in the name or surname of the person responsible or a change in the registered office, residence, name, business name or surname of the licence holder or of a special licence pursuant to the directly applicable European Union5), the natural persons, legal persons and public authorities involved shall, within 10 working days of such change, submit to the Ministry an application for a change of licence or a special licence on a form the model of which is laid down in the implementing legislation and shall attach to the application:
(a) evidence of the appointment of the responsible person under the directly applicable European Union3) and evidence of the medical and professional competence of the responsible person under Article 11 (3) and (4), if the responsible person has changed; evidence of medical and professional competence shall not be attached to the application for modification of the special licence;
(b) evidence of a change in the name or surname of the responsible person where the change in the name or surname of the responsible person has occurred; or
(c) an extract from the commercial or similar register of the applicant or the establishment document of the applicant, where the registered office, residence, name, business name or surname of the licence holder or special licence has changed.
(3) The amendment of the licence or special licence pursuant to the directly applicable European Union5) and the extension of the licence or special licence shall take place by issuing a new licence or special licence.
§ 4
Validity of licences and special licences
(1) Licences shall be issued for a period of 3 years and special licences shall be issued for an indefinite period, with the exception of licences or special licences issued on the basis of an application for an amendment of a licence or a special licence as referred to in Article 3 (2), which shall be issued for the period of validity of a licence or a special licence which has been amended. If the natural persons, legal persons or authorities of the State so request, the Ministry shall issue them a licence or a special fixed-term licence.
(2) Licences and special licences are non-transferable and do not pass on to the successor in title.
(3) The validity of the licence or special licence shall end with the withdrawal of the licence or special licence or the issue of a new licence or special licence, but not later than the expiry of the period for which it was issued. The first sentence shall not apply to a licence or special licence which preceded a licence or a special licence issued on the basis of an application for a new licence or a special licence pursuant to Article 3 (1).
(4) An invalid licence or a special licence shall be obliged to return to minister6 within 10 working days of the expiry of the licence. The natural persons, legal persons and public authorities involved may also return to the Ministry a valid licence or special licence if they no longer carry out the activity for which the licence or special licence was issued to them.

HLAVA II

REGISTRATION FOR ACTIVITIES WITH ADDED CATEGORIES 2 AND 3
§ 5
Application for registration and application for a specific marketing authorisation
(1) Entrepreneurial natural persons, legal persons and public administrations intending to operate with that substance of category 2 under the directly applicable European Union1) or category 3 under the directly applicable European Union7) are required to submit an application for registration to the Ministry (8) on a form the model of which is laid down in the implementing legislation.
(2) If a pharmacist, the Customs Administration of the Czech Republic, the Police of the Czech Republic, the Military Police, the Prison Service of the Czech Republic, the General Inspection of the Security Corps or the Army of the Czech Republic intend to operate with the scheduled category 2 substance in accordance with directly applicable European Union9), they are required to apply to the Ministry for a special registration (10) on a form the model of which is laid down in the implementing legislation.
(3) The application for a marketing authorisation and the application for a specific marketing authorisation must include, in addition to the general procedural requirements of the administrative procedure,
(a) the name and code of the Combined Nomenclature of scheduled substances of category 2 or 3 with which the applicant intends to operate under the directly applicable European Union1),
(b) the specification of the activity with that substance of category 2 or 3 according to the directly applicable European Union1) which the applicant intends to perform;
(c) the addresses of the establishments where the applicant intends to operate with that substance of category 2 or 3 in accordance with directly applicable European Union1); and
(d) the name or, where applicable, the name, surname, address of the place of permanent residence, job title and signature or recognised electronic signature (11) of the responsible person or contact person.
(4) The Ministry shall register the registrant and issue him a registration certificate,
(a) if the integrity of the applicant and the responsible person or contact person is demonstrated in accordance with Article 10,
(b) if the applicant has accompanied the application for registration with an extract from the applicant's commercial or similar register or the applicant's instrument of incorporation; and
(c) if the applicant has accompanied the application for registration with evidence of the appointment of the responsible person in accordance with directly applicable European Union3 regulations) or the contact person in accordance with § 12.
(5) The Ministry shall register the applicant for a specific registration and issue a special registration certificate if the applicant has accompanied the application for a specific registration
(a) a permit for the provision of medical care, issued by the competent authority, where it is a provider of medical care;
(b) an extract from the commercial or similar register of the applicant, where it is a provider of medical care; and
(c) proof of appointment of the responsible person in accordance with the provisions directly applicable to the European Union3).
§ 6
Notification of change in registration data
Where a change in registration data is made, the natural persons, legal persons and administrative authorities involved shall, within 10 working days of the date on which the change took place, notify the Ministry of that change by means of a form the model of which is laid down in the implementing legislation and the notification shall be accompanied by a document similar to the documents referred to in Article 5 (4) or (5) supporting the amendment. The Ministry shall make a change to the registration or special registration and issue a new registration certificate or special registration to the natural person, legal person or authority.
§ 7
Activity notification
(1) Registered natural persons, legal persons and public authorities are required to inform the Ministry by 31 March each year whether they continue the activities for which they were registered. This information may be provided only on a form the model of which is laid down in the implementing act.
(2) If the natural persons, legal persons or public authorities concerned cease to carry out all the activities for which they were registered, they may notify the Ministry in writing. The notification referred to in the first sentence shall cancel the registration or special registration of the undertaking of the natural person, legal person or public authority.
§ 8
Validity of registration and special registration
(1) The Ministry shall register the individual activities for an indefinite period of time of business natural persons, legal persons and government authorities; if the natural persons, legal persons or public authorities concerned so request in a registration or special registration, they shall be registered by the Ministry for a fixed period.
(2) The registration or special registration shall end with the withdrawal of the registration or special registration or the expiry of the period for which the applicant has been registered.
(3) Registration certificates and special registration certificates are issued for the period for which the applicant has been registered. The expiry of a marketing authorisation or a specific marketing authorisation or a change in the marketing authorisation or a specific marketing authorisation shall result in the invalidity of a marketing authorisation or a specific marketing authorisation. An invalid registration certificate or special registration shall be returned to the Ministry within 10 working days of the expiry of the licence.
(4) Registration certificates and special registration certificates are non-transferable. Registration and special registration shall not be transferred to the successor in title.

HLAVA III

PERFORMANCE AND PERIOD OF PERFORMANCE OR STRENGTH IN THE CZECH REPUBLIC
§ 9
(1) The Ministry shall issue a licence or a special licence only to an entrepreneur or register only an entrepreneur who is fit and has a permanent residence in the Czech Republic. The Ministry shall issue to the legal person a licence or a special licence or a legal person the Ministry shall register only if he / she is righteous, if he / she is a legal person who is entitled to act for it and has a seat in the Czech Republic. The condition of permanent residence or registered office in the Czech Republic shall not apply if it is a person who has a permanent residence or residence permit, place of business, registered office, central administration, principal place of business or organisational component in the territory of another Member State of the European Union, the Contracting State of the Agreement on the European Economic Area or the Swiss Confederation.
(2) For the purposes of this Act, a natural or legal person who has not been convicted of a criminal offence committed in direct connection with a drug precursor or a narcotic or psychotropic substance shall be considered as a natural or legal person.
§ 10
Demonstration of integrity
(1) The integrity is demonstrated
(a) an extract from the register of punishments which is not more than 3 months old;
1. for a natural person with a place of residence in the Czech Republic,
2. in the case of a natural person who is, or was, a national of another Member State of the European Union or in another Member State of the European Union, has or has been resident;
3. in the case of a legal person established in the Czech Republic,
(b) proof of a similar extract from the Register of Penalties which is not more than 3 months old;
1. for a natural person with a place of residence outside the Czech Republic and for a natural person who has remained continuously outside the Czech Republic for more than 6 months in the last 5 years; a document similar to the extract from the Register of Penalties must be issued for that purpose by the competent authority of the State of residence of that person, of the States in which that person has been continuously present for more than 6 months in the last 5 years and of the State which is not the same as that of that person's residence and that person is his citizen,
2. in the case of a legal person established outside the Czech Republic; a document similar to the extract from the Register of Penalties must be issued for that purpose by the competent authority of the State of residence; and
(c) an honest declaration of integrity
1. in the case of a natural person, if the State of residence of that person and the State where that person has remained continuously during the last 5 years, he / she does not issue the document referred to in point (b); an affidavit of integrity must be made before a notary or an authorised authority of the State of residence of that person and of States in which that person has remained continuously for more than 6 months in the last 5 years;
2. in the case of a legal person, where the State of the registered office of a legal person does not issue the document referred to in point (b); a declaration of integrity must be made before a notary or an authorised authority of the State of residence.
(2) In order to demonstrate the integrity of the person referred to in paragraph 1 (a) (1) or (3), the Ministry shall obtain, in accordance with another legislation12) an extract from the Register of Penalties; If necessary to obtain an extract, the Ministry may require the person referred to in paragraph 1 (a) (1) to communicate his / her birth number allocated by the competent authority of the Czech Republic (13). The Ministry may also obtain additional supporting documents if necessary to verify the information established in accordance with paragraph 1.

ČÁST TŘETÍ

Responsible and CONTACT PERSONS
§ 11
Eligibility of the responsible person
(1) Entrepreneurial natural persons, legal persons and public administrations, with the exception of persons, legal persons and public authorities who issue a special licence or are subject to a special registration, may only appoint the responsible person a fair natural person who is:
(a) a member of their statutory body;
(b) their staff member in an employment relationship agreed for at least half of the fixed weekly working hours under the Labour Code; or
(c) a member of their service.
The employment relationship referred to in point (b) shall be established by contract of employment and the employment relationship referred to in point (c) shall be demonstrated by decision of admission to service or by a service card. Paragraph 10 shall apply mutatis mutandis to the demonstration of the integrity of the responsible person.
(2) In addition to the conditions set out in paragraph 1, the responsible person for operating with that category 1 substance, with the exception of the responsible person appointed by the natural persons, legal persons or public authorities issuing the specific licence, shall comply with the conditions of medical and professional competence.
(3) The medical fitness referred to in paragraph 2 shall be demonstrated by a medical assessment on medical fitness which is not more than 3 months old on the day on which the licence application is submitted. Health-competent person responsible for the activity with that category 1 substance
(a) only a natural person may be recognised who may be presumed not to be in danger of his or her health or life in the performance of his or her duties in relation to his or her health, and
(b) the natural person in whose body the examination carried out for the purpose of the first sentence is carried out may not be recognised as being a narcotic or psychotropic substance, unless the presence of that substance is due to medical prescription.
(4) Only a natural person with a full completed higher education in a Master's study programme in an area corresponding to the needs for the proper performance of the duties of the responsible person may be recognised as a competent person for the activity with that category 1 substance. This condition shall be demonstrated by a university diploma.
§ 12
Appointment and competence of the contact person
(1) Business natural persons and legal persons intending to handle the substance category 3 are required to appoint a contact person at the latest by the date of the registration.
(2) Only an upstanding natural person may be appointed by the contact person. Article 10 shall apply mutatis mutandis to the demonstration of the integrity of the contact person.
§ 13
Temporary incapacity of the responsible person
(1) The natural persons, legal persons and public authorities involved shall be required to appoint representatives of the person responsible no later than immediately after, as a result of the temporary inability of the person responsible to perform his or her duties, the obligations laid down directly applicable by European Union1) or by this law, or the performance of those obligations is jeopardised.
(2) The representative of the responsible person may be appointed only by a natural person who fulfils the conditions of competence of the responsible person pursuant to Article 11 (1) and (2) by analogy.
(3) After the appointment of a representative of the responsible person, the undertaking natural person, legal person and public administration are required to submit immediately to the Ministry:
(a) proof of appointment of the representative of the person responsible,
(b) proof of the integrity of the representative of the responsible person, unless it can be demonstrated in accordance with the procedure laid down in Article 10 (2);
(c) proof of the employment or service relationship of the representative of the person responsible pursuant to Article 11 (1), mutatis mutandis;
(d) evidence of medical fitness of the representative of the responsible person in accordance with Article 11 (3) by analogy; and
(e) evidence of the professional competence of the representative of the responsible person in accordance with Article 11 (4), mutatis mutandis;
and if the responsible person is temporarily unable to perform his duties, immediately notify the Ministry in writing of the beginning of that incapacity.
(4) For the duration of the temporary inability of the responsible person to perform his or her duties, the representative of the responsible person shall perform the full function of the responsible person.
(5) The termination of the temporary incapacity of the responsible person shall be notified in writing to the Ministry by the natural persons, legal persons and public authorities without undue delay.
(6) The obligations referred to in paragraphs 2 and 3 (b) to (d) shall not apply to commercial natural persons, legal persons and public authorities which issue special licences or which are subject to special registration.
§ 14
Permanent incapacity of the responsible person and contact person
(1) If the responsible person for the activity with that category 1 substance ceases to comply with the eligibility conditions of § 11 (1) and (2) or is permanently unable to perform his duties or renounces his or her duties for other reasons, the natural persons, legal persons and public authorities involved shall be obliged to appoint a new responsible person without delay.
(2) The appointment of the new person responsible shall be subject to the obligation to inform the Ministry without delay of the appointment of the natural person, legal person and public authorities and to submit an application for a change of licence or special licence pursuant to Article 3 (2) within 10 working days of its appointment.
(3) Where the responsible person for the activity with that category 2 substance ceases to fulfil the eligibility conditions under Article 11 (1) or if the contact person ceases to comply with the condition of integrity under Article 12 (2) or if the responsible person for the activity with that category 2 substance or the contact person for other reasons is permanently unable to perform his or her duties or renounces his or her duties, the natural persons, legal persons or public authorities shall be obliged to appoint a new responsible person or contact person without delay, to the Ministry pursuant to Article 6 and to return to the Ministry an invalid registration certificate or special registration pursuant to Article 8 (3).
§ 15
Some other activities of the responsible person and contact persons
(1) Before commencing an activity for which a licence or special licence is required, the natural persons, legal persons and public authorities involved shall ensure that such activity is not carried out without the consent of the person responsible.
(2) When taking over a scheduled substance of category 1, 2 or 3, the responsible person shall ensure that the quantity and type of scheduled substance with accompanying documents are checked and immediately notified to the police of the Czech Republic and the Ministry of Justice of the irregularities detected.
(3) The responsible person for the activity with that category 1 substance signs written communications, notifications, submissions and documents in accordance with the directly applicable European Union Regulation) or this Act, in particular:
(a) licence applications or applications for special licences (2);
(b) customer declarations 14),
(c) an application for an export authorisation or an application for an import authorisation (15);
(d) reports pursuant to Sections 19 and 27 and directly applicable European Union16),
(e) the communication of estimates pursuant to Sections 20 and 29;
(f) evidence of loss, destruction, disposal or transfer for disposal of or containing Category 1 scheduled substance;
(g) a record of activity with that category 1 substance under the directly applicable European Union Regulation (17), in particular an inventory document;
(h) the control report carried out; and
(i) proof of the acquisition, sale or disposal of a technological device for the manufacture of a scheduled category 1 substance or a medicinal product containing it, in particular tablettes, an auction boiler or a granulation boiler.
(4) The responsible person for the activity with that category 2 substance shall sign written communications, notifications, submissions and documents in accordance with the directly applicable European Union Regulation (1) or this Act, in particular:
(a) the application for a marketing authorisation or the application for a specific registration8),
(b) customer declarations 14),
(c) application for export authority18),
(d) reports pursuant to Sections 19 and 27 and directly applicable European Union16),
(e) evidence of loss, destruction, disposal or transfer for disposal of the scheduled substance of category 2; and
(f) the control report made.
(5) The contact person shall communicate with the competent administrative authorities and sign:
(a) application for registration (8);
(b) application for export authority18),
(c) reports pursuant to Article 19 and directly applicable European Union16),
(d) evidence of loss of category 3 scheduled substance; and
(e) the report on the control carried out.

ČÁST ČTVRTÁ

EXPORTS AND IMPORTS
§ 16
Application for export authorisation and application for import authorisation
(1) An application for an export authorisation or an application for an import authorisation under the directly applicable European Union19) or an application for an export authorisation by a simplified procedure under the directly applicable European Union20) is required to submit to the Ministry the natural persons, legal persons and public authorities concerned by the provisions of the implementing legislation.
(2) An export authorisation shall be issued by the Ministry only to business natural persons, legal persons or government bodies which accompany the application referred to in paragraph 1 with an authorisation to import that substance to be exported, issued by the State where the export is to take place. Where that State does not issue such an authorisation, the natural persons, legal persons or public authorities involved shall be required to attach to the application referred to in paragraph 1 proof of the consent of the State to which the export is to be made with the import of the scheduled substance to be exported, if that State issues it.
§ 17
Non-transferable export and import authorisation
Export authorisations and import authorisations shall not be transferable and shall not be transferred to the successor in title.
§ 18
Notification of non-export and import
If the export or import does not take place during the period of validity of the export or import authorisation, the natural persons, legal persons and public authorities involved shall, within 10 working days of the expiry of the export or import authorisation, be required to return this fact and the reason why the export or import has not taken place in writing to the Ministry and the export or import authorisation to the Ministry.
§ 19
Export and import reports
(1) Commercial natural persons, legal persons and public administrations who, in the calendar month, have exported scheduled substances of category 1, 2 or 3 from the customs territory of the European Union or imported category 1 substances into the customs territory of the European Union by import authorisation, are required to provide the Ministry with a monthly summary report of such exports and imports and related intermediary activities.
(2) The notification referred to in paragraph 1 shall be made on a form the model of which is laid down in the implementing act by the 15th day of the following calendar month.
§ 20
Estimated imports
(1) Entrepreneurial natural persons, legal persons and public administrations licensed to import under the directly applicable Regulation of the European Union21 are required to communicate to the Ministry the total estimate of scheduled substances of category 1 and their quantities which they intend to import into the customs territory of the European Union on the basis of the licence in the year of issue of the licence and in the year following the year of issue of the licence, immediately after the issue of the licence. In the years following the year of issue of the licence, the natural persons, legal persons and public authorities concerned shall communicate to the Ministry the total estimate of scheduled Category 1 substances and their quantities which they intend to import into the customs territory of the European Union in the following year, each year during the period of validity of the licence, by 30 April each year.
(2
(3) Where an estimate of scheduled substances of category 1 changes or an increase in the estimated quantity of scheduled substances of category 1 as referred to in paragraphs 1 and 2 after the date of notification of the estimate to the Ministry, the natural persons, legal persons and public authorities concerned shall immediately communicate a new estimate to the Ministry.
(4) The notification of the estimate referred to in paragraphs 1, 2 and 3 shall be made on a form the model of which is laid down in the implementing act.

ČÁST PÁTÁ

STORAGE, TRANSPORT, TRADE AND DISASTER

HLAVA I

STORAGE
§ 21
Storage of scheduled Category 1 substances
(1) Entrepreneurial natural persons, legal persons and public administrations are obliged to:
(a) store the scheduled substance of category 1
1. in a separate locked room, the walls, ceilings, floors, windows and doors of which are opaque and of a material which makes penetration into a stored category 1 substance difficult,
2. in a non-portable, locked box of steel, or
3. in a special, for this purpose made by a locked device inseparably anchored to a wall, ceiling or floor of solid materials, in particular bricks or concrete panels,
(b) adequately ensure the protection of the scheduled substance of category 1 and its equipment against loss, theft or abuse, in particular by continuous physical surveillance or by appropriate technical means, in particular fencing and electronic security equipment; and
(c) to ensure the release of keys from the room, storage or equipment where the scheduled category 1 substance is stored only to designated persons and to store them separately from the keys to the other premises of the building.
(2) Paragraph 22 shall apply mutatis mutandis to the storage of scheduled substances of category 1 by the police of the Czech Republic, the General Inspection of Security Corps and the customs authorities of the Czech Republic in the performance of their tasks.
§ 22
Storage of scheduled substances of category 2
Commercial natural persons, legal persons and public authorities shall be required to adequately ensure the protection of that substance from loss, theft or abuse when storing a Category 2 substance.

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Regulation Information

CitationAct No. 272 / 2013 Coll., on drug precursors
Regulation TypeLaw
Author-
CollectionCode of Laws
Date of Promulgation10.09.2013
Effective from01.01.2014
Effective until-
Status Valid
The regulation text is for informational purposes only.
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