272/2013 Sb.



LAW



of 22 March. August 2013



on drug precursors



Parliament has passed the following Act of the Czech Republic:



PART THE FIRST



INTRODUCTORY PROVISIONS



§ 1



The subject of the edit



This law regulates the following on directly applicable provisions of the European

Union ^ 1)



and conducting business) certain obligations of natural persons, legal persons, and

public authorities, which are engaged in or intend to address

activities with a scheduled substance of category 1, 2 or 3, with non-scheduled substance

or with the default or excipient (hereinafter referred to as "the precursor drugs"),



(b) the scope of the administrative authorities) State administration by directly

applicable European Union legislation regulating drug precursors ^ 1) and

This law,



(c)) the implementation of the checks on compliance with the obligations laid down directly

applicable European Union legislation governing drug precursors ^ 1) and

This Act and



d) penalties for infringement of obligations laid down directly applicable

European Union legislation governing drug precursors ^ 1) and this Act.



PART THE SECOND



LICENSING AND REGISTRATION



TITLE I OF THE



LICENCES for activities involving scheduled substances of category 1



§ 2



The licence application and of the request for special license



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

which they propose to carry out activities with a scheduled substance of category 1 according to

the directly applicable European Union legislation ^ 1), are required to submit

The Ministry of health (hereinafter referred to as "the Ministry") for the licence

or request for a specific license ^ 2) on a form, a specimen of which is set out

the implementing legislation, and to accompany the application



proof of appointment) of the person responsible according to directly applicable regulations

The European Union ^ 3),



(b) the work or) proof of service of the responsible person referred to in section 11

paragraph. 1,



(c) proof of medical fitness) of the responsible person referred to in section 11 (1). 3,



(d)) evidence of professional competence, the persons responsible in accordance with § 11 (1). 4,



(e) stating that the decision to permit) the production according to the law on pharmaceuticals,

where a licence for activities with specified substance in category 1, in order to

the manufacture of the medicinal product or medicinal substances, or the authorization to distribute

According to the law on pharmaceuticals, asks if the licence to operate with that

substance in category 1 for the purpose of distribution of medicinal substances, and



(f) a description of the intended production technology), asks if the license to manufacture

scheduled substances of category 1.



The documents referred to in points (b) to (f))) do not attach to the application for the Special

the license.



(2) a special license shall be issued to the providers of medical care, customs

the administration of the Czech Republic, Police of the Czech Republic, the military police,

The prison service of the Czech Republic and the army of the Czech Republic.



§ 3



The request for amendment or renewal of a license or special licenses



(1) an application for a new licence or special license because of changes in the

the information set out in the licence or a special license by directly

the applicable regulation in the European Union ^ 4) and a request for extension of a licence

or special licenses are entrepreneurial natural persons, legal persons, and

public authorities are required to submit on a form, a specimen of which is set out

the implementing legislation, and to accompany the application of the annex referred to in § 2

paragraph. 1, with the exception of the annexes that have been attached to the earlier

applications for a licence or a special licence, and which at the date of

request not to change in the particulars specified therein; This fact

are the entrepreneurial natural persons, legal persons and the institutions of State administration

required to substantiate the affidavit.



(2) If there is a change of the responsible person, change of name or surname

the responsible person or the change of the registered office, place of residence, the name, trade name or

the name or the surname of the holder of the licence or the special licences referred to in directly

the applicable regulation in the European Union ^ 5), are entrepreneurial natural persons

legal persons and State administration bodies shall within 10 working days from the

This change to the Ministry to lodge a request for the amendment of a licence or specific

the license on a form, a specimen of which is set out in the implementing the legal

Regulation, and to accompany the application



proof of appointment) of the person responsible according to directly applicable regulations

The European Union ^ 3) and evidence of health and professional competence, responsible

a person under section 11 (2). 3 and 4, if there is a change of the responsible person;

evidence of health and competence is not enclosed to the application for

change special licences,



(b) the proof of change of name) or the last name of the person responsible, if there

the change of the name or surname of the person responsible, or



c) extract from the commercial register or the like of the applicant or the provisioning

the instrument of the applicant, if there is a change of the registered office, place of residence, the name, trade

company or name or surname of the holder of the licence or a special license.



(3) the amendment of a licence or a special license by directly applicable

Regulation of the European Union) and the extension of the ^ 5 licenses or special licenses

shall be made by the issue of a new licence or special license.



§ 4



The validity of the licences and special license



(1) a Licence shall be issued for a period of 3 years and a special license shall be issued to the

for an indefinite period, with the exception of the licence or a special license issued by the

the basis of the request for amendment of a licence or special licenses under section 3 (3).

2, which shall be issued for a period of validity of the licence or a special license, with

which the change occurred. If the entrepreneurial natural persons, legal

the persons or public authorities so request, shall issue them a Ministry license

or a special license for a specified period.



(2) licences and special licences are non-transferable and does not pass to the legal

the successor.



(3) the validity of the licence or the licence expires the licence of the special detention or

special licence or the release of a new licence or special licenses

but not later than the expiry of the period for which it was issued. The provisions of clauses

the first does not apply for a license or a special license, which preceded the

license or a special licence issued on the basis of an application for a new license

or a special license pursuant to section 3 (3). 1.



(4) an invalid license or special license are entrepreneurial natural

persons, legal entities and State administration bodies are obliged to return

the Ministry ^ 6) within 10 working days from the date of its expiry.

Entrepreneurial natural persons, legal entities and State authorities may

the Ministry also return a valid license or a special license,

If you already exercise activity that the licence has been or

a special licence is issued.



TITLE II



REGISTRATION for activities involving scheduled substances of CATEGORY 2 and 3



§ 5



The application for registration and application for special registration



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

which they propose to carry out activities with a scheduled substance of category 2 according to

the directly applicable European Union legislation ^ 1) or category 3 according to the

the regulation directly applicable European Union ^ 7), are required to submit

the Ministry of a request for registration ^ 8) on a form, a specimen of which is

laid down in the implementing regulation.



(2) If a provider of care, the customs administration of the Czech

of the Republic, the police of the Czech Republic, the military police, the prison service

The Czech Republic, or the army of the Czech Republic intend to carry on business with a

scheduled substance of category 2 by directly applicable regulations of the European

Union ^ 9), are required to submit a special request to the Ministry of

registration ^ 10) on a form, a specimen of which is set out in the implementing the legal

the code.



(3) a request for registration and application for special registration must

General requirements for filing in accordance with administrative regulations contain



and the name) and the combined nomenclature code of the scheduled substance of category 2 or

3, with which the applicant intends to carry out activities under the directly applicable

European Union legislation ^ 1),



(b) activities with that specification) of the substance in category 2 or 3 under

the directly applicable European Union legislation ^ 1), which the applicant intends to

exercise,



(c)) the addresses of the premises at which the applicant intends to carry out activities with a

scheduled substance of category 2 or 3 according to the directly applicable provisions

The European Union ^ 1), and



(d) the name or names), surname, and address of the place of residence,

job title and signature of the recognized electronic signature or ^ 11)

the responsible person or the contact person.



(4) the applicant for registration, the Ministry registers and shall issue him a certificate

concerning the registration,



and if proven) is the integrity of the applicant and the persons responsible or

contact person under section 10,



(b) if the applicant) put to the application for registration of a business or

like the register the applicant or the applicant's incorporation Charter and



(c)) where the applicant to put the request on the registration document of appointment

person responsible according to the directly applicable European Union legislation ^ 3) or

the contact person referred to in section 12.



(5) the applicant for the Special Registration Department registers and issue him a

certificate of special registration, put the applicant in the application for

special registration



and) permission to provide pharmaceutical care, issued by the competent

authority, if the provider of care,



b) extract from the commercial register or the like of the applicant, if

the provider of care, and



(c) proof of appointment) of the person responsible according to directly applicable regulations

The European Union ^ 3).



§ 6



Notification of changes in registration data
When a change in the registration data are the entrepreneurial natural persons,

legal persons and State administration bodies shall within 10 working days from the

the date of the change, notify this change to the Ministry on the form,

the model is determined by the implementing regulation, and to the notification

attach a document similar to the documents under section 5 (3). 4 or 5 stating

This change. The Ministry will implement a change in registration or special

registration and entrepreneurial natural person, legal person or body

the State administration shall issue a new certificate of registration or a special

the registration.



section 7 of the



Reporting on the activities



(1) registered entrepreneurial natural persons, legal persons and authorities

the State administration are obliged to report each year to the 31. March

the Ministry on whether to continue the activities for which they were

registered. This information may only be submitted on the form of which a specimen

is laid down in the implementing regulation.



(2) if the entrepreneurial natural persons, legal persons or authorities of the State

the administration shall cease to carry out all the activities for which they were

registered, may in writing notify the Ministry.

The notification referred to in the first sentence, the registration or special registration

entrepreneurial natural persons, legal persons or authority of the State administration

cancels.



§ 8



The validity of the registration and special registration



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration

the Ministry registers for each activity for an indefinite period of time;

If the entrepreneurial natural persons, legal persons or authorities

State administration in the application for registration or special registration request

registers is the Ministry for a certain period.



(2) the Registration or cancellation of registration special registration expires or

special registration or the expiry of the period for which the applicant has been

registered.



(3) the certificate of registration and certificate of special registration

be issued for the period for which the applicant has been registered. The end of the

registration or special registration or a change in the registration or

special registration leads to the invalidation of the registration certificate or

special registration. Invalid registration certificate or special

registration are the entrepreneurial natural persons, legal persons and authorities

the State administration shall be obliged to return to the Ministry within 10 working days from the date of

the end of its validity period.



(4) the certificate of registration and certificate of special registration

not transferable. Registration and special registration is transferred to a legal

the successor.



TITLE III



THE CONDITION OF INTEGRITY AND PERMANENT RESIDENCE OR REGISTERED OFFICE IN THE CZECH REPUBLIC



§ 9



(1) the Ministry shall issue the licence or special licence only doing business

a natural person or a natural person-entrepreneur only registers that

It is impeachable and has permanent residence in the territory of the Czech Republic. Legal

the Ministry will issue a licence to the person or special license or legal

person Ministry registers, only if it is impeachable, if

good repute which persons are authorised to act for it, and if it has its registered office in

The Czech Republic. The condition of permanent residence or registered office in the Czech Republic

shall not apply, if it is about a person who has a permanent residence permit

or place of residence, place of business, the registered office, Central Administration, principal place of

his business or organizational folder on the territory of another

the Member State of the European Union, of a Contracting State of the agreement on the European

economic area or the Swiss Confederation.



(2) Must, for the purposes of this Act, means the natural or legal

a person who has not been convicted of an offence committed in

direct connection with the prekursorem drug or narcotic or psychotropic

the substance.



§ 10



Demonstrating integrity



(1) the integrity of the proof



and from the dump), criminal records, that is not older than 3 months,



1. in the case of a natural person residing in the territory of the Czech Republic,



2. in the case of a natural person is or was a national of another

the Member State of the European Union or in another Member State of the European Union

has or had a place of residence,



3. in the case of a legal person established on the territory of the Czech Republic,



(b) a similar statement from the document), criminal records, that is not

older than 3 months,



1. for natural persons resident outside the territory of the Czech Republic and for

a natural person who, in the past 5 years continuously resided

outside the territory of the Czech Republic for more than 6 months; the document like

extract from the criminal register must be issued to authorized

authority of the State of residence of the person, the State in which the person in

the last 5 years continuously resided for more than 6 months, and

the State, which is not the same as the State of residence of the person and the person is

the citizen,



2. in the case of a legal person located outside the territory of the Czech Republic; document

similar to the extract from the criminal register must be issued to

the legitimate authority of the State and



(c) a sworn declaration of integrity)



1. in the case of a natural person, if the State of residence of the person and the State where the

the person in the last 5 years continuously resided, does not issue the document

referred to in subparagraph (b)); affidavit of integrity must be made

before a notary public or by the competent authority of the State of residence of the person and States,

in which this person in the past 5 years continuously resided after

For more than 6 months,



2. in the case of a legal person, if the State of the seat of a legal person does not issue

the proof referred to in subparagraph (b)); affidavit of good character must be

made before a notary public or by the competent authority of the State of residence.



(2) in order to demonstrate the integrity of a person referred to in paragraph 1 (b). and)

section 1 or 3 of the Ministry's purchasing according to another legal

Code ^ 12) an extract from the criminal register; If it is to obtain

the statement necessary, may the Ministry after the person referred to in paragraph 1 (b). and)

section 1 require the communication of its personal identification number allocated by the competent

authority of the Czech Republic ^ 13). The Ministry may obtain any other

supporting documents, if it is necessary to verify the information referred to in paragraph

1.



PART THE THIRD



THE RESPONSIBLE CONTACT PERSON AND



§ 11



The eligibility of the person responsible



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

with the exception of the entrepreneurial natural persons, legal entities and institutions

the State administration, which issues special licences or are subject to

special registration, the person responsible may designate only impeccable integrity

a natural person who is



and a member of the statutory body),



(b)) an employee in their employment on at least half of the agreed

weekly working time laid down by the labour code, or



(c)) in their national proportion.



The employment relationship referred to in subparagraph (b)), shows an employment contract and

the service referred to in subparagraph (c)) shall be demonstrated by a decision on admission to the

service or staff ID card. For proof of good repute

the responsible person shall apply article 10 mutatis mutandis.



(2) the person responsible for the activity with a scheduled substance of category 1, with

the exception of the responsible person appointed by the active physical persons,

legal persons or public authorities, which shall be issued

special licences, must in addition to the conditions laid down in paragraph 1 shall comply with the

the conditions of health and competence.



(3) Health eligibility referred to in paragraph 2 shall carry a medical

opinion on medical fitness, which on the day of lodging of licence applications

It is not older than 3 months. Eligible disabled person responsible for

working with that substance in category 1



and recognized only) can be a natural person, for which it can be assumed that the

When the performance of the duties of the responsible person is not threatened her health, or

life or during the performance of this function in the context of health

the State is not a threat to the health or life of other persons, and



(b)) cannot be recognized by a natural person in which the organism was in the

the examination has been carried out for the purpose of drawing up the report referred to in the first sentence,

presence of a narcotic or psychotropic substance, if it is not about the presence of the

This substance because of the doctor prescribed treatment.



(4) a competent person responsible for the activity that

substance category 1 can be recognized only by a natural person with the proper

completed university degrees in the master's degree programme in

the area corresponding to the needs for the proper performance of the functions of the responsible person.

This condition is showing a university diploma.



§ 12



The appointment and qualification of the contact person



(1) the entrepreneurial natural persons and legal persons who wish to be treated

with a scheduled substance in category 3, they shall, not later than on the date of submission of the

application for authorization to appoint a contact person.



(2) the contact person can be appointed only the unblemished natural person.

For the proof of the integrity of the contact person section 10 shall apply mutatis mutandis.



section 13



Temporary inability of the responsible person



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration

are required to appoint a representative of the responsible person at the latest immediately after the

then, when as a result of the temporary incapacity of the person responsible to carry out their

the function does not comply with the obligations laid down directly applicable provisions of the European

the Union "^ 1") or this Act or performance of these duties is compromised.
(2) a representative of the responsible person can be appointed only to a natural person,

which satisfies the conditions for eligibility of the person responsible in accordance with § 11 (1). 1

and (2) apply mutatis mutandis.



(3) after the appointment of a representative of the responsible persons are entrepreneurial natural

persons, legal entities and State administration bodies shall be obliged to immediately

submit to the Ministry of



and proof of the appointment of the representative) responsible persons,



(b) proof of the integrity of the representative) of the person responsible, if it cannot be

demonstrate the procedure under section 10, paragraph 1. 2,



(c) the working or) proof of service of the representative person responsible

under section 11 (2). 1 Similarly,



(d) proof of medical fitness), a representative of the responsible person referred to in section 11

paragraph. 3 Similarly, and



e) proof of the technical competence of the representative person responsible according to § 11

paragraph. 4 Similarly,



and where the responsible person is temporarily unable to perform their function,

notify the Department in writing without delay the onset of the incapacity.



(4) for the duration of the temporary incapacity of the person responsible to carry out their

the function shall be a representative of the responsible person of the responsible person in the full feature

the range.



(5) termination of temporary inability of the responsible persons are doing business

natural persons, legal entities and State authorities shall without

undue delay, notify the Department in writing.



(6) the obligations referred to in paragraph 2 and paragraph 3 (b). (b) to (d)))

apply for the entrepreneurial natural persons, legal persons and authorities

the State administration, which issues special licences or are subject to

special registration.



§ 14



The persistent inability of the responsible person and contact persons



(1) if the person responsible for the activity with a scheduled substance of category 1

no longer meets the conditions of eligibility under section 11 (2). 1 and 2 or is

for other reasons, permanently unable to carry out their function or performance

their function, gives up, are entrepreneurial natural persons, legal persons, and

State administration bodies shall be obliged to immediately appoint a new responsible

the person.



(2) on the appointment of the new responsible person are entrepreneurial natural persons

legal persons and State administration bodies shall be obliged to immediately inform the

the Ministry and within 10 working days from its appointment request

change of license or special licence pursuant to § 3 (2). 2.



(3) if the person responsible for the activity with a scheduled substance in category 2

no longer meets the conditions of eligibility under section 11 (2). 1, or if the

contact the person no longer meets the condition of integrity under section 12

paragraph. 2 or if the person responsible for the activity with the substance

category 2 or contact person for other reasons unable to permanently

to carry out their function or performance of their functions, are entrepreneurial surrenders

natural persons, legal persons or public authorities are obliged to

shall immediately appoint a new person in charge, or contact person, this

change notify the Department under section 6 and the return to the Ministry of invalid

a certificate of registration or a special registration pursuant to section 8 (2). 3.



§ 15



Some of the other activities of the responsible person and contact persons



(1) prior to the activity for which the licence is required or special

the licence, are entrepreneurial natural persons, legal persons and authorities

the State administration shall be obliged to ensure that this activity will not be carried out without

the consent of the responsible person.



(2) when taking the scheduled substances of category 1, 2 or 3 person responsible

provides compliance checking the quantity and type of substances listed with the accompanying

documents and immediate notification of irregularities detected the police of the Czech

of the Republic and the Ministry.



(3) the person responsible for the activity with a scheduled substance of category 1

signs a written communication, notification, filing and documentation by directly

the applicable regulation in the European Union "^ 1") or this law, in particular



and) licence or a request for special license ^ 2)



(b)) a customer Declaration ^ 14)



(c)), the application for an export permit or request for the import authorization ^ 15),



(d) under section 19 of the report) and 27 and by directly applicable regulations of the European

Union ^ 16),



(e)) the communication of the estimates under section 20 and 29,



f) proof of the loss, destruction, disposal or transfer for disposal

scheduled substances of category 1 or waste containing it,



(g)) record activities with a scheduled substance of category 1 according to directly

the applicable regulation in the European Union ^ 17), and in particular proof of the inventory,



h) Protocol on inspection and



I) proof of purchase, sale or disposal of technological equipment to

the production of scheduled substances of category 1 or medicinal product it

containing, in particular, tabletovačky, dražovacího or granulačního

the boiler.



(4) the person responsible for the activity with a scheduled substance in category 2

signs a written communication, notification, filing and documentation by directly

the applicable regulation in the European Union "^ 1") or this law, in particular



and) application for registration or application for special registration ^ 8),



(b)) a customer Declaration ^ 14)



(c) the application for export authorization) ^ 18),



(d) under section 19 of the report) and 27 and by directly applicable regulations of the European

Union ^ 16),



(e) proof of loss), destruction, disposal or transfer for disposal

scheduled substances in category 2 and



(f) Protocol on inspection).



(5) contact person communicates with the competent administrative authorities of the

and signed by the



application for authorization) ^ 8),



(b) the application for export authorization) ^ 18),



(c) pursuant to section 19 of the report) and by directly applicable regulations of the European

Union ^ 16),



(d) proof of loss mentioned) category 3 substances and



(e)) the Protocol on inspection.



PART THE FOURTH



EXPORTS AND IMPORTS



section 16 of the



Application for export permit and the application for an import permit



(1) an application for an export permit or request for the import authorization referred to in

the regulation directly applicable European Union ^ 19) or a request for the grant of

export authorizations using the simplified procedure under directly applicable

Regulation of the European Union ^ 20) are the entrepreneurial natural persons, legal

the persons and bodies of State administration are obliged to submit to the Ministry on the form,

the model is determined by the implementing regulation.



(2) the Ministry shall issue the export permit only operating the physical

persons, legal persons or bodies of the State administration, which the application

referred to in paragraph 1 shall be accompanied by an import permit provided the substances to be

exported, issued by the State where the export takes place. If this State

This permit is not issued, the entrepreneurial natural persons, legal persons

or public administration bodies are obliged to the request referred to in paragraph 1 apply

the proof of the consent of the State where the export takes place, with the importation of the said

the substance, which is to be exported, if this State is issued.



§ 17



Non-transferability of export and import permit



Export permits and import permits are non-transferable and does not pass on

legal successor.



section 18



Notice of non-export and import



If the export or import in the period of validity of import or export

the authorization does not take place, are entrepreneurial natural persons, legal persons, and

State administration bodies shall within 10 working days from the date of the end of the

the validity of an export or import permit, this fact and the reason

Why exports or imports, in writing to the Ministry and

export or import authorisation to return to the Ministry.



§ 19



Reports on exports and imports



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

exported in a calendar month on the basis of export permit

scheduled substances of category 1, 2 or 3 from the customs territory of the European Union or

imported on the basis of the import authorisation scheduled substances of category 1 on

the customs territory of the European Union, are required to pass the Ministry monthly

the summary reports of these exports and imports and the United

intermediary activities.



(2) the Report referred to in paragraph 1 shall be made on a form, a specimen of which is

laid down in the implementing regulation, the 15th day of the following

the calendar month.



section 20



The estimate of imports



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

which import licence has been issued under the directly applicable regulation

The European Union ^ 21), are required to communicate to the Ministry of the total estimate

those of category 1 substances and their quantities on the basis of which they intend to

licences to import to the customs territory of the European Union in the year of issue of the licence and, in the

the year following the year of issue of the licence, it shall, without delay after the issue of the

licence. In the years following the year of the edition of the licences are operating

natural persons, legal entities and State administration bodies are obliged to communicate to the

the Ministry of the total estimate of scheduled substances in categories 1 and their

the quantity on the basis of the licences that they intend to import into the customs territory of the

The European Union next year, and every year for the duration of the licence

always 30. April.



(2) the entrepreneurial natural persons, legal persons and the institutions of State administration,

which are referred to in the regulation directly applicable European Union ^ 22)

exempt from the requirement to import license shall be required to

immediately after submission of the application for the first import authorisation in a calendar

communicate to the Ministry in the overall estimate of scheduled substances of category 1 and

their quantity in the edition of this import permit and in

following the year of release of the import authorisation they intend to bring to the

the customs territory of the European Union.



(3) changes the estimate of scheduled substances of category 1 or increase
estimate the amount of listed substances of category 1 in accordance with paragraphs 1 and 2, after the date of

the communication Ministry estimate, the entrepreneurial natural persons, legal

the persons and bodies of State administration shall be obliged to immediately communicate the new estimate

the Ministry.



(4) the communication of the estimate referred to in paragraphs 1, 2 and 3 shall be made on form

the model is determined by the implementing regulation.



PART THE FIFTH



STORAGE, TRANSPORT, TRADE AND DISPOSAL



TITLE I OF THE



STORAGE



section 21



Storage of scheduled substances of category 1



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration

are required to



and) stored substance in category 1



1. in a separate locked room, whose walls, ceiling, floor, Windows and

the doors are opaque and znesnadňujícího penetration from the material to the

stored substance in category 1,



2. in the non-transferable, the locked box of steel, or



3. in particular, for this purpose, zhotoveném a protected device

inextricably into the walls, ceiling, docked or hard floors

materials, particularly brick or concrete panels,



(b) the protection referred to mutatis mutandis) substances in category 1 and

its production from loss, theft or misuse, especially

24 x 7 physical security or by appropriate technical means,

in particular, fencing and electronic security device, and



(c) secure the key issue from the) room, container or equipment where the

stored substance in category 1, the only designated persons and their

store separately from keys from other areas of the object.



(2) for the storage of scheduled substances of category 1 of the police of the Czech Republic and

The customs administration of the Czech Republic in the fulfilment of their tasks, instead of

paragraph 1 shall apply, mutatis mutandis, to section 22.



section 22



Storage of scheduled substances in category 2



Entrepreneurial natural persons, legal persons and the institutions of Government are

When the storage of scheduled substances of category 2 are required to adequately secure

its protection against loss, theft, or misuse.



TITLE II



To the RIGHT



section 23



Transport of scheduled substances of category 1



(1) the substance of category 1 can be transported only in a locked

a metal container or in a specially designed bag provided

the locking mechanism or in the enclosed means of transport

modified so as to prevent leakage of scheduled substances of category 1

outside of the enclosed space.



(2) while loading, transporting and unloading of scheduled substances of category 1 are

entrepreneurial natural persons, legal persons and the institutions of State administration

required to ensure 24-hour surveillance.



(3) if the transport Provides scheduled substances of category 1 for doing business

natural persons, legal persons or bodies of the State administration of the third person

This does not affect the responsibility of entrepreneurial natural persons, legal persons

authority or the authority of the State administration for the loss, destruction or misuse of the transported

scheduled substances of category 1 in accordance with this Act.



(4) shipments of scheduled substances in category 1 shall be amended and shall not

be disclosed to the public.



section 24



Transport of scheduled substances in category 2



Entrepreneurial natural persons, legal persons and the institutions of Government are

during loading, transport and unloading of the scheduled substances in category 2 shall

to ensure its protection from loss, theft or misuse.



TITLE III



TRADE AND DISPOSAL OF



§ 25



Trade in scheduled substances in category 2



Entrepreneurial natural persons, legal entities and State authorities may

substance category 2 deliver customer only, that is

registered for activities with this scheduled substance by directly

applicable European Union legislation ^ 8), if so directly applicable

Regulation of the European Union ^ 23). This are the entrepreneurial natural

persons, legal entities and State administration bodies shall before the

delivery for customer verification.



section 26



Disposal of scheduled substances of category 1



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration

are obliged to neutralize that substance in category 1, with which it already

not or cannot perform the activity described in the directly applicable

European Union legislation "^ 1"), and the waste substance in category 1

containing. When disposal proceed similarly as when deleting

hazardous waste according to the law governing the handling of wastes.



(2) the entrepreneurial natural persons, legal persons and the institutions of State administration

are required to at least 10 working days prior to the disposal of that substance

category 1 of the disposal of the police of the Czech Republic and the General

the Directorate of customs.



(3) the entrepreneurial natural persons, legal persons or authorities of the State

the Administration, which referred to a substance in category 1 or waste containing

break, takes on the disposal of the Protocol whose pattern is determined

the implementing legislation. The Protocol must contain



and the name of the scheduled substance destroyed) category 1 and its quantity,



(b) the disposal, reason)



(c)) date and place of disposal and



(d)) list and signatures of the persons who were present, including the disposal of the

a person who is authorized by another act performed

the disposal.



PART SIX



THE NOTIFICATION OBLIGATION, THE RECORDS AND DOCUMENTS



TITLE I OF THE



THE NOTIFICATION REQUIREMENT OF



section 27 of the



Reports on the quantities of excess/bulky



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

in the calendar month indicated on the market of the Czech Republic or other

the Member State of the European Union the selected substance of category 1 or

2 in an amount that exceeds the limit of the quantities laid down in the implementing

by law, are required to pass the Ministry about this month

the summary report.



(2) the list of the selected scheduled substances in categories 1 and 2, lays down the detailed

legal prescription.



(3) the Information referred to in paragraph 1 shall be made on a form, a specimen of which is

laid down in the implementing regulation, the 15th day of the following

the calendar month.



section 28



Provide aggregated data about the activities of the



Entrepreneurial natural persons, legal persons and the institutions of Government are

required to provide summary information on the activities of the Ministry, with the

substance of category 1, 2 or 3 according to the applicable regulations of the European right

unie16) on the forms, specimens of which are governed by the legal

the code.



section 29



An estimate of the production



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

which the licence has been issued for the manufacture of the substances listed in category 1 are

required to communicate to the Ministry of the total estimate of scheduled substances of category 1 and

their quantity, that they intend to make on the basis of licences in issue

the licence and in the year following the year of issue of the licence, and shall immediately

After the issuance of the licence. In the years following the year of the edition of the licences are

entrepreneurial natural persons, legal persons and the institutions of State administration

required to communicate to the Ministry of the total estimate of scheduled substances of category 1 and

their quantity, that they are going to on the basis of a licence to produce in the next

year, and each year after the period of validity of the licences to 30. April.



(2) changes the estimate of scheduled substances of category 1 or increase

estimate the amount of listed substances of category 1 in accordance with paragraphs 1 and 2, after the date of

the communication Ministry estimate, the entrepreneurial natural persons, legal

the persons and bodies of State administration shall be obliged to immediately communicate the new estimate

the Ministry.



(3) the communication of the estimate referred to in paragraphs 1 and 2 shall be filed on a form, a

the pattern is laid down in the implementing regulation.



TITLE II



RECORDS AND DOCUMENTS AND THEIR STORAGE



section 30



Records of activities involving scheduled substances of category 1 and 2



(1) the content, form and requirements for keeping records of activities with the

substance of category 1 in accordance with the regulation directly applicable European Union ^ 17)

lays down detailed legal prescription.



(2) a record of the activity with the substance of category 1 or 2 in accordance with directly

the applicable regulation in the European Union ^ 17) must be kept so that the

prevent their deterioration, loss, destruction, misuse or theft,

for a period of at least 5 years from the date of the record.



section 31



Documents about activities involving scheduled substances of category 1



Entrepreneurial natural persons, legal persons and the institutions of State administration,

that deal with the activities of that substance in category 1, shall

keep the supporting documents for this activity, in particular



and receipt and delivery) scheduled substances of category 1,



(b)) the loss of, destruction and disposal of substances listed in category 1 or waste

containing it,



(c) the acquisition, sale and) disposal of technological equipment for production

scheduled substances of category 1 or of a medicinal product containing it,

in particular, the tabletovačky, dražovacího or granulačního boilers, boilers



(d)) the checks carried out,



e) official decisions, including the official decision of the foreign States,

relating to activities with a scheduled substance in category 1,



(f) the reports pursuant to section 19) and 27 and by directly applicable regulations

The European Union ^ 16) and



(g)) the estimates under section 20 and 29.



§ 32



Documents about activities involving scheduled substances of category 2 and 3



Entrepreneurial natural persons, legal persons and the institutions of State administration,

engaged in activities with scheduled substance of category 2 or 3, are

required to retain evidence of this activity, in particular



and the loss, destruction) and disposal of scheduled substances of category 2 or 3,



(b)) the checks carried out,
(c)), including the official decisions of the official decision of the foreign States,

relating to activities with the substance and category 2 or 3, and



(d) the reports pursuant to section 19) and 27 and by directly applicable regulations

The European Union ^ 16).



section 33



Documentation and retention period of documents



Entrepreneurial natural persons, legal persons and the institutions of Government are

required to retain documentation of the activity with the substance of category 1

or 2 by the directly applicable European Union legislation ^ 24) and documents

According to section 31 and 32, in order to prevent their deterioration, loss,

destruction, misuse or theft, and for a period of at least 5 years from the date of

the acquisition of the document or a document, or from the date of the last record in it,

and whichever of these facts occurred later.



PART SEVEN



MEDICINAL preparations containing SCHEDULED SUBSTANCES of CATEGORY 1



§ 34



In the activities with the medicinal product ^ 25) that contains that substance

category 1, proceed according to the law governing the treatment of

in narcotic drugs and psychotropic substances ^ 26).



PART EIGHT



THE DEFAULT AND AUXILIARY SUBSTANCES



section 35



(1) the default and auxiliary substances "means substances which are not

scheduled substances of category 1, 2 or 3, but because of their frequent

abuse and the importance for the illicit manufacture of narcotic drugs, psychotropic

or scheduled substances of category 1, 2 or 3 of them can doing business

natural persons, legal entities and State authorities handled only

the conditions laid down in this law.



(2) for the purposes of this part, the provisions of section 6, 7, 8 and § 14 paragraph. 3

Similarly.



section 36



Obligations before the delivery of the default and auxiliary substances on the market



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

intending to deliver to the market of the Czech Republic or other Member

States of the European Union the default or excipient in quantity, which in its

the sum in one year for one of the default or excipient

exceeds the quantitative limit fixed by law, are

not later than the date of the initiation of the activities required to



and) be registered and



(b)) to appoint a contact person for activities with the default and auxiliary

substances according to § 12 apply mutatis mutandis.



(2) the request for registration shall be made on a form, a specimen of which is set out

the implementing legislation, and in addition to the General requirements for filing by

administrative procedure must contain the



and the name of the default) or auxiliary substances, which the applicant intends to deliver on

the market of the Czech Republic or other Member States of the European Union,



(b)) the addresses of the premises at which the applicant intends to carry on business with the default

or excipient, and



(c) the name or names), surname, and address of the place of residence,

job title and signature of the recognized electronic signature or ^ 11)

contact person for activities with the default and auxiliary substances.



(3) the registrant registers and the Ministry shall issue him a certificate

concerning the registration,



and if proven) is the integrity of the applicant, which is operating the physical

a person or a legal person, and the contact person for activities with

the default and auxiliary substances according to § 10,



(b) if the applicant) put to the application for registration of a business or

like the register the applicant or the applicant's incorporation Charter and



(c)) where the applicant to put the request on the registration document of appointment

contact person for activities with the default and auxiliary substances.



§ 37



The obligation to supply the default and auxiliary substances on the market



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

that supply to the market of the Czech Republic and other Member States

The European Union, the default or excipient in quantity, which in its

the sum in one year for one of the default or excipient

exceeds the quantitative limit fixed by law, are

required to



and to report to the Ministry) per month of the quantities delivered to the default and auxiliary

substances with an indication of the customer on a form, a specimen of which is set out

the implementing legislation, the 15th day of the following

calendar month,



(b) retain evidence of income) and the issue of default and auxiliary substances,

in order to prevent their deterioration, loss, destruction, misuse or

theft, and for a period of at least 5 years from the date of their acquisition, and



(c) immediately notify the police) of the Czech Republic and the Ministry of all the

suspicious circumstances, in particular the unusual order from the default or auxiliary

substances, which suggest that a default or auxiliary substance can be exploited

in the illicit manufacture of narcotic drugs, psychotropic substances or category

1, 2, or 3.



(2) the default and auxiliary substances may not be delivered to a physical person, which

It is not an entrepreneur. The other person can entrepreneurial natural persons

legal persons and public bodies to deliver a default or a helping

substance, only receives from her prior to the delivery of a duly completed

customer declaration form, a specimen of which is set out in the implementing

legal regulation.



section 38



Some of the other activities of the contact person for the activities with the default and

auxiliary substances



Contact person for activities with the default and auxiliary substances ensures

communicating with the competent authorities and shall be signed by



and) application for registration according to § 36 odst. 2,



(b)), pursuant to section 37, paragraph. 1 (a). and)



(c) the proof of loss,) the destruction, disposal or transfer for disposal

the default or auxiliary substances and



d) documents relating to checks carried out.



PART NINE



CONTROL AND ADMINISTRATIVE DELICTS



TITLE I OF THE



CHECK



section 39



(1) the control of compliance with the obligations arising from the directly applicable

European Union legislation ^ 27), of this law and of the decision issued by the

the basis of the exercise



and staff credentials)



1. ministries and



2. The State Institute for drug control and



(b)) members



1. The police of the Czech Republic and



2. The customs administration of the Czech Republic



(hereinafter referred to as "inspectors").



(2) the inspectors referred to in paragraph 1 (b). and shall section 1) card

the Inspector, a specimen of which is set out in the implementing regulation.



(3) inspectors may do well in advance of an unannounced inspection and in the range of

strictly necessary for the performance of control samples. Compensation for taken

the sample shall be reimbursed by the competent administrative authority and to natural persons,

legal persons or bodies of the State administration only on their written

request.



TITLE II



ADMINISTRATIVE OFFENCES



section 40



(1) the Entrepreneurial natural person, legal person or authority of State administration

is guilty of misconduct, that contrary to the directly applicable

European Union legislation governing drug precursors ^ 28)



and) exercises an activity which requires a license or special licenses

without a valid license or a special license,



(b)) activity, which requires the registration or special

registration, without registration or a special registration, or



(c)), or take that substance without a valid export or

the import permit.



(2) the Entrepreneurial natural person, legal person or authority of State administration

is guilty of misconduct, that contrary to the directly applicable

European Union legislation governing drug precursors ^ 1)



and adds that substance category) 1 customer, who is not the holder of the

license or a special license,



(b)) adds that substance category 1 customer and nepřiloží the consignment with the

This substance, a copy of the customer declaration bearing the stamp and date,

certify the conformity with the original text,



(c)) shall supply the substance of category 1 or 2 customers and does not accept from

the customer duly completed Declaration of the customer



(d)) does not properly all the operations that lead to the placing of the said

substances of category 1 or 2 on the market, or does not properly all exports

or the importation of the scheduled substances or intermediary brokers

activity,



(e)) does not ensure that the substance of category 1 or 2 have been before delivery

properly fitted with a label, or that the packaging containing the substance is

bears the name of a containing listed substances,



(f)) in a timely and properly to the Ministry does not provide summary information on their

activities with the substance or summary data on export or import

listed substances or intermediary activities related thereto,



g) proven, at the request of the Office of the holiday trade purposes, do not submit

the Customs Office of export or import authorisation in the case of, so provide

directly applicable regulation the European Union ^ 7), or does not ensure that the export

the authorisation shall accompany the consignment to the country of export or import authorisation

accompany the consignment to the customs territory of the European Union,



(h)) does not specify the details of each export operation on the rear side of the

Copy No 2 of the export authorisation granted by simplified procedure,

or does the Declaration or the documents accompanying

the export consignment for each export operation permit number and the words

"simplified export authorisation procedure", or



I) return copy No 2 of the export authorisation granted by simplified

the procedure the Ministry within 10 working days from the expiry of this

the authorization.



(3) the Entrepreneurial natural person, legal person or authority of State administration

further committed misconduct by



and) contrary to section 3 (3). 2 or § 14 paragraph. 2 does not give a timely request for change
license or a special license or nepřiloží annex to this application

According to § 3 (2). 2 (a). and (c)))



(b)) in contravention of section 4, paragraph 4. 4 back in time to the Ministry of an invalid license

or a special license,



(c)) in contravention of section 6 of the duly notifies the Department of a change in the registration

data,



d) contrary to section 7 (2). 1 does not inform the Ministry about it in a timely manner, whether the

continues the activities for which the person is registered or

for which this authority was registered,



e) contrary to section 8 (2). 3 or § 14 paragraph. 3 back in time to the Ministry of

invalid registration certificate or special registration,



(f)) in contravention of section 13 (3). 1 appoint a representative of the responsible person in a timely manner,



(g)) in contravention of section 13 (3). 3 do not submit in due time the Ministry document pursuant to section

13 (3). 3 (b). and (d))) or in breach of section 13 (3). 3 or 5 fails to notify

in time, in writing, to the Ministry of the beginning or the end of the temporary incapacity

the person responsible to carry out their function,



h) contrary to section 14, paragraph. 1 or 3 in time to appoint a new responsible or

the contact person is responsible, or if the contact person is permanently unable

to carry out their function,



I) in contravention of section 14, paragraph. 2 immediately notifies the Ministry of

the appointment of the new responsible person or contrary to § 14 paragraph. 3 notifies the

in time the Ministry of a change of the responsible person or the contact person



j) in contravention of section 15(1). 1 does not provide in an efficient manner, that the operation of the

which requires a license or a special license, will not be carried out without

the consent of the persons responsible,



k) in contravention of section 18 has not notified in time to the Ministry of the non-export

or imports or to communicate in due time to the Ministry of the reason why the export or

imports, or come back in time to the Ministry of export or import

the authorization,



l) does not pass on time and properly Ministry summary reporting of exports or

imports under section 19,



m) do not communicate in due time to the Ministry estimate of the imports referred to in section 20, or an estimate of the production

According to section 29,



n) stored substance in category 1, in contravention of section 21 or stored

a category 2 substance in contravention of section 22,



about) treated, transported or unloaded substance in category 1

contrary to section 23 or handled, transported or unloaded substance

category 2 contrary to section 24,



p) in contravention of section 25 shall supply the substance category 2 neregistrovanému

the customer,



q) nezneškodní substance in category 1, with which it already does not intend to, or

cannot perform operation by directly applicable regulations of the European

the Union "^ 1") or the waste containing the substance in category 1, under section 26,



r) does not pass in time to the Ministry reports on excess/bulky quantities pursuant to section

27. 1,



with) does not keep track of the activity with a scheduled substance of category 1 in accordance with section

30 paragraph. 2, or does the documentation activity with the substance

category 1 or 2, or proof of activities with a scheduled substance of category

1, 2 or 3 under section 33,



t) does not retain evidence of activity with a scheduled substance of category 1

in section 31 or does not retain evidence of activity with a scheduled substance of category 2

or 3 referred to in section 32,



u) contrary to § 36 odst. 1 (a). and will supply a default or) excipient

on the market in quantities which, in aggregate, during one year for one

the default or excipient exceed the quantitative limit established

the implementing legislation, without registration or a special registration,



in the) contrary to § 36 odst. 1 (a). (b)) to appoint a contact person for the

activities with the default and auxiliary substances and will supply a default or a helping

the substance on the market in quantities which, in aggregate, during one year for

one default or excipient exceed the quantitative limit established

the implementing legislation,



w) does not report on time and properly to the Ministry of the quantities delivered to the default and

excipients, stating the customer pursuant to section 37, paragraph. 1 (a). and)



x) does not retain evidence of receipt and delivery of default and auxiliary substances

pursuant to section 37, paragraph. 1 (a). (b)), or



y) in contravention of section 37, paragraph. 2 gives the default or excipient, the physical

a person who is not an entrepreneur, or supplies the default or excipient

another person and does not receive her before the delivery of the completed

customer Declaration.



§ 41



Fine



(1) for the administrative offence under § 40 paragraph. 1 you can impose a fine in



and 5 0000 0000 Czk), with respect to the administrative offence under (a)), or (b)),



(b)) 3 0000 0000 CZK in the case of an administrative offence referred to in subparagraph (c)).



(2) for the administrative offence under § 40 paragraph. 2 you can impose a fine in



1 0000 0000 Czk), with respect to the administrative offence under (a)), (c) or (d))),



b) 500 000 CZK in the case of an administrative offence referred to in subparagraph (b)), e) or (g)),



c) 250 000 CZK in the case of an administrative offence referred to in subparagraph (f)), h) or even).



(3) for the administrative offence under § 40 paragraph. 3 you can impose a fine in



2 0000 0000 Czk), with respect to the administrative tort by the letter n) to q), u)

or y),



(b)) 1 0000 0000 CZK in the case of administrative tort by the letter s), t)) or

x),



c) 500 000 CZK in the case of an administrative offence referred to in subparagraph (f)), h), (j)) or

w),



d) 250 000 CZK in the case of an administrative offence under (a) to (c))), e), (g)),

I), k) and m) or r).



section 42



The withdrawal of the licence and cancellation of registration



For the administrative offence under § 40 paragraph. 1 (a). (c)), section 40 paragraph. 2 or § 40

paragraph. 3 (b). and) to t) or in) up to y) can be used together with the imposition of fines

withdraw the license or a special license or cancel the registration or

special registration.



§ 43



Forfeiture of things



For the administrative offence under section 40 may be combined with another penalty save penalty

prekursoru drugs and the confiscation of the equipment and materials needed to

production, if the offender belongs to the misconduct and have been



and) to commit misconduct designed,



(b)) to commit misconduct used,



c) committing misconduct or



(d)) acquired as a matter of administrative deliktem obtained.



§ 44



Prevents things



If the penalty was forfeiture of things according to § 43, may decide that

the thing works, if



and belongs to the offender which) cannot be prosecuted for the administrative offence, or



(b)) do not belong to the perpetrators of the misconduct or does not belong to him completely,

If required by the safety of persons or property or another general interest.



section 45



Common provisions



(1) for the administrative offence under § 40 paragraph. 3 (b). (d)) unable to save another

penalty than the cancellation of the registration.



(2) in determining the amount of the fine, as well as the kind of sanctions, taking into account the

the severity of the misconduct, in particular to the way a criminal offence and its

the consequences of, and the circumstances under which the offence was committed was administrative.



(3) liability of legal persons for the administrative offence shall cease, if the

competent administrative authority about him has commenced proceedings within 3 years from the date when the

aware of it, but not later than 5 years from the date when the administrative

the offence was committed.



(4) Administrative offenses under section 40 shall address, in the first instance by the Ministry,

with the exception of administrative offences



and the provider of care) committed pursuant to § 40 paragraph. 1 (a).

and (b)),) and § 40 paragraph. 2 (a). and), c) and (d)) and § 40 paragraph. 3 (b). and (c)))

e) to (j)), n), q), with) and t),



(b) committed in the transport) according to § 40 paragraph. 2 (a). (b)), and (e)) and section 40

paragraph. 3 (b). o) and



(c)), pursuant to section 40 paragraph. 2 (a). g) and (h)).



(5) administrative offences pursuant to § 40 paragraph. 1 (a). and (b)),) and § 40 paragraph. 2

(a). and), c) and (d)) and § 40 paragraph. 3 (b). and (c))), e) to (j)), n), q)) and

t), committed by the provider of care, in the first instance

State Institute for drug control.



(6) administrative offences pursuant to § 40 paragraph. 2 (a). (b)), and (e)) and § 40 paragraph. 3

(a). about) committed during transport and in accordance with § 40 paragraph. 2 (a). g) and (h))

be dealt with in the first instance by the Customs Office.



(7) the financial penalty is payable within 30 days of the date when the power came

the decision, in which it was stored. The fine collected and enforced by the administrative authority,

that saved her. Income from fines is the income of the State budget.

Decision on the imposition of fines can be done within 5 years from the date of expiry of the

for its payment.



(8) the owner of the forfeited or seized of the matter under section 43 or 44 becomes

State.



PART TEN



THE COMPETENCE OF ADMINISTRATIVE AUTHORITIES



section 46



The Ministry of



The Ministry in addition to the activities covered by this law and directly

the applicable provisions of the European Union ^ 1)



and the competent authority) is for negotiations with the European Commission in the field of

legal activities involving scheduled substances of category 1, 2 and 3 and the default and

auxiliary substances,



(b) monitor compliance with this Act) and compliance with the directly applicable

European Union legislation ^ 1) in the framework of its competence,



(c) imposing sanctions)



(d)) shall decide on the issuance of the licence and the specific licenses and registers in accordance with

the directly applicable European Union legislation ^ 29),



e) shall decide on the issue of the export and import permit by directly

the applicable regulation in the European Union ^ 30),



(f)) decides on the issue of assent to the export and import of substances

under the control regime of export and import in the States and in accordance with the requirements of the

The United Nations,



g) handles the advance notification of exports of scheduled substances by directly

the applicable regulation in the European Union ^ 31),



h) processes and evaluates the information about excess/bulky quantities pursuant to section

27,



I) processes and evaluates the summary information on the activities with the

substances of category 1, 2 and 3 according to the applicable regulations of the European right

Union ^ 16),



j) provides the European Commission with information on drug precursors within the

the scope of the set directly applicable European Union legislation ^ 32),
to provide the European Commission) of the Organization of the United Nations, the authorities of the

the State administration and the competent authorities of foreign States on the basis of information

their application,



l) shall inform the Ministry of Foreign Affairs, the European Commission and in the

If necessary, the Member States of the European Union on legislative changes

and scope of the State authorities in accordance with applicable regulations of the European right

Union ^ 33),



m) cooperate with the competent authorities of the States referred to export and import

substances of category 1, 2 and 3,



n) cooperates with the International Office for the control of narcotic substances ^ 34),



about) keeps records of the entrepreneurial natural persons, legal persons, and

public authorities, in which the licence was issued or special licenses

and which have been registered,



p) keeps records of foreign countries, which are under the control regime of the substance,

non-scheduled substances of category 1, 2 or 3, and the registration of those

substances,



q) confirms the export authorization issued by the competent authority of the exporting State and



r) exposes the patterns of the forms referred to in this law means that allow

remote access.



section 47



The police of the Czech Republic



The police of the Czech Republic



and the competent authority) is for negotiations with the European Commission in the field of

legal activities with non-scheduled substances under the directly applicable

European Union legislation ^ 35) and illegal activities with drug precursors,



(b) monitor compliance with this Act) and compliance with the directly applicable

European Union legislation ^ 1) in the framework of its competence,



(c) inform the Ministry about all) relevant facts necessary

for the decision of the Ministry under this Act and by directly

applicable European Union legislation ^ 1), and in particular about the attempts of alienation

of drug precursors,



(d) at the request of the Ministry) are involved in the inspection or inspections,



(e)). the supporting documents shall be sent to the Ministry in April for the previous calendar year

for the statistical reports by directly applicable regulations of the European

Union ^ 32),



(f) submit to the Ministry of information about) any other substance not included in the

Annex I to the regulation directly applicable European Union ^ 7), or not specified

the substance, which was found to have been used for the illicit manufacture of narcotic drugs

or psychotropic substances, including proposals for measures to prevent it

proliferation and misuse, and



(g) submit to the Ministry of information) forms, methods and resources

the illicit production of narcotic drugs and psychotropic substances through the use of precursors

drugs.



section 48



The Directorate-General of customs duties



The Directorate-General of customs duties



and the competent authority) is for negotiations with the European Commission in the field of

legal activities with non-scheduled substances under the directly applicable

European Union legislation ^ 35) and the illegal export and import of these substances,



(b) monitor compliance with this Act) and compliance with the directly applicable

European Union legislation ^ 1) in the framework of its competence,



(c) inform the Ministry about all) relevant facts necessary

for the decision of the Ministry under this Act and by directly

applicable European Union legislation ^ 1), and in particular about the attempts of alienation

or the smuggling of drug precursors,



(d) at the request of the Ministry) are involved in the inspection or inspections,



e) until 31 December 2006. the supporting documents shall be sent to the Ministry in March for the previous calendar

year for the statistical reports by directly applicable regulations of the European

Union ^ 32),



(f) submit to the Ministry of information about) any other substance not included in the

Annex I to the regulation directly applicable European Union ^ 7), or not specified

the substance, which was found to have been used for the illicit manufacture of narcotic drugs

or psychotropic substances, including proposals for measures to prevent it

dissemination and exploitation,



(g) submit to the Ministry of information) forms, methods and resources

the illicit production of narcotic drugs and psychotropic substances through the use of precursors

drug and



(h) be sent to the European Commission) an overview of the data by directly applicable

Regulation of the European Union ^ 36).



section 49



The Customs authorities of the



The Customs authorities of the



and data) on the export authorization and import permit and

check that the consignment is in accordance with the issued export or import

enabling, including checks of consignments stored in customs warehouses in accordance with

the regulation directly applicable European Union ^ 37),



(b)) that are entrepreneurial natural persons, legal persons, and

State authorities that intend to export the substance in category 1,

2 or 3, or import the substance of category 1 or 2 for this activity

entitled to; If not entrepreneurial natural person, legal person, or

State authorities authorized for this activity, will not allow the export or

imports and immediately inform the Ministry of ^ 38),



(c)) shall check that quantities of scheduled substances in category 3

do not exceed the limits set by the directly applicable European regulation

Union ^ 39),



(d)) shall check compliance with the obligations arising from section 23, 24 and 32 and from the

the regulation directly applicable European Union ^ 37) during transport,



(e)) shall immediately inform the Ministry about the differences or

other important facts regarding the illegal export attempts

or the importation of the scheduled substances of category 1, 2 or 3,



(f)) of this Act shall check compliance with and adherence to the directly applicable

European Union legislation ^ 1) in the framework of its competence and



(g) imposing sanctions).



section 50



State Institute for drug control



State Institute for drug control



and) within its scope controls the compliance with this Act and the

compliance with the directly applicable European Union legislation ^ 1) providers

pharmaceutical treatments,



(b)) and the Ministry shall inform the sanctions imposed the penalties imposed and



(c)) shall inform the Police of the Czech Republic and the Ministry of the

violations of the directly applicable European Union legislation ^ 1) and this

the law.



PART ELEVEN



THE PROVISIONS OF THE COMMON, TRANSITIONAL AND FINAL, ENABLING



section 51



Common provisions



For the issue of a licence, a special licence, export licence and of the import

the authorization shall apply the provisions on the issue of the document referred to in the administrative code.

The certificate of registration and certificate of special registration

the certificates referred to in part four of the administrative procedure.



section 52



Transitional provisions



(1) the entrepreneurial natural persons, legal persons and the institutions of State administration,

registered by the Ministry under section 16 of the Act No. 167/1998 Coll., on

addictive substances and amending certain other acts, as amended effective

before the date of entry into force of this law, that they intend to continue to

continue the activity with the substance in category 2 or 3 according to the right

applicable European Union legislation ^ 1), it shall notify the

the Ministry within a period of 6 months from the date of entry into force of this Act,

otherwise, the Department shall cancel the registration. On the basis of the notification pursuant to sentence

First, the Ministry registers the entrepreneurial natural persons, legal

the persons and bodies of State administration in the period of 4 months from the filing date of the

the notification. The notification shall be submitted on the form according to § 7 (2). 1.



(2) permits and special permits for treatment with the drug precursors, issued

According to the Act No. 167/1998 Coll., on addictive substances and amending certain

other laws, in the version effective before the date of entry into force of this

law, shall be construed as a license or a special license by directly

applicable European Union legislation ^ 2) and remain in force until the

in these permits.



(3) a permit to import and export of drug precursors, issued pursuant to the Act No.

167/1998 Coll., on addictive substances and amending some other acts,

in the version effective before the date of entry into force of this Act, shall remain in

valid until the time specified in the permits.



(4) the entrepreneurial natural persons, legal persons and the institutions of State administration,

that before the date of entry into force of this Act



and supply the default or helper) of the substance referred to in section 35, paragraph. 1 on the Czech market

the Republic or other Member States of the European Union and that they intend to

deliver the substance on the market in the Czech Republic and other Member States

The European Union even after the date of entry into force of § 35 paragraph. 2, § 36 odst. 1 and 3,

sections 37 and 38, are required to submit an application for registration according to § 36 odst. 2, and

within 3 months from the date of entry into force of this Act,



(b)) do not supply default or auxiliary substance according to § 35 paragraph. 1 on the market

The Czech Republic and other Member States of the European Union and that

begin to deliver the substance on the market of the Czech Republic or other Member

States of the European Union before the date of entry into force of § 35 paragraph. 2, § 36

paragraph. 1 and 3, § 37 and 38 and they intend to deliver it even after that date, are

required to submit an application for registration according to § 36 odst. 2 to 10

working days from the date when this began to supply the substance on the market in the Czech

the Republic or other Member States of the European Union. Doing business

natural persons, legal persons or bodies of the State administration, the Ministry of

register within 90 days from the date of submission of the application.



section 53



The enabling provisions



(1) the Government shall determine by regulation the list of default and auxiliary substances according to §

paragraph 35. 1 and the annual quantitative limits in accordance with § 36 odst. 1 and section 37, paragraph. 1.

For a list of default and auxiliary substances the Government may classify a substance,



and that is significant when) the illicit manufacture of narcotic drugs or psychotropic

the substance; significant in the illicit manufacture of narcotic or psychotropic substances,
may be the only substance whose chemical alteration of a narcotic cannot be obtained

or psychotropic substance, but the substance can be used in the illicit

manufacture of narcotic drugs or psychotropic substances, indirectly, such as

a catalyst for chemical reactions,



(b)) that is often misused for the illicit manufacture of narcotic drugs or

psychotropic substances and



(c)) will not endanger the activities of the holidays with this disproportionately substance; for

the purpose of preventing undue risk to holiday activities with a substance may

Government for this substance to establish annual quantitative limit, which

nepřekročením the substance on the list of default and auxiliary substances

not be considered a default or excipient.



(2) the Ministry shall issue a decree for the implementation of section 2 (2). 1, section 3, paragraph 3. 1 and

2, section 5 (3). 1 and 2, section 6, section 7 (2). 1, § 16. 1, § 19 paragraph. 2, section 20

paragraph. 4, section 26, paragraph. 3, § 27, paragraph. 1 and 3, § 28, § 29. 3, § 30 paragraph.

1, § 36 odst. 1 and 2, section 37, paragraph. 1 and 2 and § 39, paragraph. 2.



§ 54



Final provision



This law has been notified in accordance with the directive of the European Parliament and of the

Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision

information in the field of standards and technical regulations and regulations for services

the information society, as amended.



PART OF THE TWELFTH



The EFFECTIVENESS of the



section 55



This law shall enter into force on 1 January 2005. January 2014, with the exception of the provisions

§ 35 paragraph. 2, § 36 odst. 1 and 3, § 37 and 38, which shall take effect

on 1 January 2005. July 2014.



Němcová in r.



Zeman in r.



Samantha r in r.



1) European Parliament and Council Regulation (EC) No 273/2004 of 11 March 2004.

February 2004 on drug precursors.



Council Regulation (EC) No 111/2005 of 22 December 2004. December 2004

laying down rules for the monitoring of trade in drug precursors between the

Community and third countries.



Commission Regulation (EC) No 1277/2005 of 27 June. July 2005

detailed rules for the regulation of the European Parliament and of the Council (EC)

No 273/2004 on drug precursors and for Council Regulation (EC) No 111/2005,

laying down rules for the monitoring of trade in drug precursors between the

Community and third countries.



2) Article. 3 (3). 2 regulation of the European Parliament and of the Council (EC) No.

273/2004.



Article. 6 (1). 1 Council Regulation (EC) No 111/2005.



Article. 5 and article. 12 paragraph. 1 Commission Regulation (EC) No 1277/2005.



3) Article. 3 (3). 1 regulation of the European Parliament and of the Council (EC) No.

273/2004.



Article. 3 of Commission Regulation (EC) No 1277/2005.



4) Article. 10, paragraph 1. 2 Commission Regulation (EC) No 1277/2005.



5) Article. 10, paragraph 1. 3 of Commission Regulation (EC) No 1277/2005.



6) Article. 10, paragraph 1. 4 Commission Regulation (EC) No 1277/2005.



7) Council Regulation (EC) No 111/2005.



8) Article. 3 (3). 6 European Parliament and Council Regulation (EC) No.

273/2004.



Article. 7. 1 Council Regulation (EC) No 111/2005.



9) European Parliament and Council Regulation (EC) No 273/2004.



Commission Regulation (EC) No 1277/2005.



Article 10). 3 (3). 6 European Parliament and Council Regulation (EC) No.

273/2004.



11) Act No 227/2000 Coll., on electronic signature and amending certain

other laws (the law on electronic signature), as amended

regulations.



12) Law No. 269/1994 Coll., on criminal records, as amended

regulations.



13) Law No. 133/2000 Coll., on registration of population and social security numbers and the

amendments to certain acts (the Act on the registration of inhabitants), as amended

regulations.



14) Article. 4 regulation of the European Parliament and of the Council (EC) No 273/2004.



Article 15). 13 and 21 of Council Regulation (EC) No 111/2005.



16) Article. 8 (2). 2 regulation of the European Parliament and of the Council (EC) No.

273/2004.



Article. 9 (2). 2 Council Regulation (EC) No 111/2005.



Article. 17 to 19 of Commission Regulation (EC) No 1277/2005.



17) Article. 5 (3). 4 regulation of the European Parliament and of the Council (EC) No.

273/2004.



18) Article. 13 of Council Regulation (EC) No 111/2005.



Article. 26 of Commission Regulation (EC) No 1277/2005.



Article 19). 12 and 20 of Council Regulation (EC) No 111/2005.



Article 20). 25 of Commission Regulation (EC) No 1277/2005.



21) Article. 6 (1). 1 Council Regulation (EC) No 111/2005.



22) Article. 13 of Council Regulation (EC) No 111/2005.



23) Article. 6 regulation of the European Parliament and of the Council (EC) No 273/2004.



Annex II to the regulation of the European Parliament and of the Council (EC) No 273/2004.



Article 24). 5 European Parliament and Council Regulation (EC) No 273/2004.



Article. 3 and 4 of Council Regulation (EC) No 111/2005.



25) Law No 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products), in the wording of later regulations.



26) Act No. 167/1998 Coll., on addictive substances and amending certain

other laws, as amended.



27) Article. 10 European Parliament and Council Regulation (EC) No 273/2004.



Article. 26 paragraph. 3 Council Regulation (EC) No 111/2005.



Article. 28 paragraph. 1 Commission Regulation (EC) No 1277/2005.



28) European Parliament and Council Regulation (EC) No 273/2004.



Council Regulation (EC) No 111/2005.



29) Article. 3 (3). 2 and 6 of the regulation of the European Parliament and of the Council (EC) No.

273/2004.



Article. 6 and 7 of Council Regulation (EC) No 111/2005.



30) Article. 12 to 25 of Council Regulation (EC) No 111/2005.



31) Article. 11 of Council Regulation (EC) No 111/2005.



Article 32). 13 of the European Parliament and Council Regulation (EC) No 273/2004.



Article. 32 Council Regulation (EC) No 111/2005.



Article 33). 11 of European Parliament and Council Regulation (EC) No 273/2004.



Article. 27 Council Regulation (EC) No 111/2005.



Article 34). 12 the United Nations Convention against illicit

trafficking in narcotic drugs and psychotropic substances of 1988.



Article 35). 2 (a). (b)) and article. 9 (2). 2 (a). (b)) of the European

Parliament and of the Council (EC) No 273/2004.



Article. 2 (a). (b)) of Council Regulation (EC) No 111/2005.



Article 36). 29 of Commission Regulation (EC) No 1277/2005.



Article 37). 3, 14, 22 and 26 of Council Regulation (EC) No 111/2005.



Article 38). 8 and 12 of Council Regulation (EC) No 111/2005.



Article 39). 14 Commission Regulation (EC) No 1277/2005