Act No. 281 / 2002 Coll.
Act on certain measures related to the prohibition of bacteriological (biological) and toxin weapons and the amendment of the Trade Act
Valid
Law
Effective from 28.06.2002
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281
THE LAW
of 30 May 2002
on certain measures relating to the prohibition of bacteriological (biological) and toxin weapons and the amendment of trade law
Parliament has decided on this law of the Czech Republic:
MEASURES RELATED TO THE PROHIBITION OF BAKTERIOLOGICAL (BIOLOGICAL) AND TOXIN COLLECTION
BASIC PROVISIONS
Subject matter
This law governs
(a) the rights and obligations of natural and legal persons related to the prohibition of the development, production, accumulation and use of bacteriological (biological) and toxin weapons and their destruction, the treatment of specified high risk and risk biological agents and toxins which may be misused to violate the prohibition of bacteriological (biological) and toxin weapons; and
(b) the exercise of state administration in this field.
Definition of certain terms
For the purposes of this Act:
(a) a biological agent of a micro-organism, a bacterium, a virus or a fungus, in its natural or modified state, in the form of an isolated live culture or substrate containing live material which has been deliberately inoculated or contaminated with that culture;
(b) a toxic toxic chemical resulting from metabolic processes of organisms, natural or modified, or such a substance chemically synthesised, which may cause death, disease or otherwise harm humans, animals or plants; the toxin is not the chemical if it is present in a diagnostic sample or as a natural contaminant in another material,
(c) bacteriological (biological) weapons
1. a weapon the destructive effect of which is based on the characteristics of biological agents which harm or cause the health of humans or animals, or cause their death or damage to plants or cause economic damage;
2. any device, equipment, apparatus, device designed or modified for the dissemination or use of biological agents for an enemy purpose or in an armed conflict or carrier of biological agents intentionally infected for an enemy purpose or for use in an armed conflict;
(d) a toxin weapon
1. a weapon the destructive effect of which is based on the properties of toxins which harm human or animal health or cause their death or damage plants or cause economic damage;
2. any device, equipment, apparatus or device designed or modified to spread or use toxins for hostile purposes or in armed conflict;
(e) the production of culture of biological agents reproducible by any means, synthesis, biosynthesis or extraction of non-reproducible biological agents or toxin;
(f) the management of a high-risk biological agent or toxin by the development, manufacture, use, acquisition, possession, import, export, transport or destruction of a high-risk biological agent or toxin; the management of a high-risk biological agent or toxin is not a service under the Law on the Free Movement of Services,
(g) the management of a risk biological agent or toxin by the development, manufacture, use, acquisition, possession, import, export, transport or destruction of a risk biological agent or toxin; the management of a hazardous biological agent or toxin is not a service under the Law on the Free Movement of Services,
(h) an international inspector authorised by a representative of an international organisation carrying out an inspection activity to check compliance with the Convention on the Prohibition of the Development, Production and Stocks of Bacteriological (Biological) and Toxin Weapons and on their Destruction ("the Convention") 1;
(i) prohibited information directly enabling the development or manufacture of bacteriological (biological) or toxin weapons or high risk biological agents or toxins; and
(j) the treatment of prohibited information by collection for non-preventive, protective or other peaceful purposes, the provision or publication of prohibited information.
Government administration in the area of compliance with the ban on bacteriological (biological) and toxin weapons
(1) The State Administration in the field of compliance with the ban on bacteriological (biological) and toxin weapons is carried out by the State Nuclear Safety Authority (hereinafter referred to as "the Office"), which at the same time also exercises the competence of the National Authority for Implementation of the Convention.
(2) Office
(a) supervise compliance with the ban on bacteriological (biological) and toxin weapons;
(b) supervise the management of high-risk and high-risk biological agents and toxins under this law;
(c) issue, amend and repeal decisions on authorisations for the treatment of high-risk biological agents and toxins under this law;
(d) keep a record of:
1. holders of authorisations issued under this Act and their experts; and
2. natural and legal persons handling risk biological agents or toxins as referred to in Section 17;
(e) keeps records;
1. high risk and risk biological agents and toxins,
2. workplaces where high-risk and risk agents and toxins are handled; and
3. technical and technological laboratory and manufacturing equipment of the workplaces referred to in point 2;
(f) ensure international cooperation in its field of competence.
(3) The records kept under paragraph 2 (d) are public. The records kept under paragraph 2 (e) shall be private. The Office shall, upon request, issue a complete or partial extract from the register referred to in paragraph 2 (d) to a person who demonstrates a legal interest. The release of the extract may be replaced by the provision of information from the information system in a way that allows remote access.
(4) In supervisory activities, the Office shall also use reference laboratories for high-risk and risk biological agents and toxins operated by the Ministry of Health and the Ministry of Defence in addition to its establishment.
PROHIBITION OF BAKTERIOLOGICAL (BIOLOGICAL) AND TOXIN COLLECTION AND EQUIPMENT ON THEIR PRODUCTION
(1) The development, production, acquisition, accumulation, possession, processing, use, consumption, import, export, transport and distribution of bacteriological (biological) and toxin weapons or other management of bacteriological (biological) and toxin weapons and the management of prohibited information, including support or financing of such activities, shall be prohibited.
(2) The development, manufacture, acquisition, accumulation, possession, import, export, distribution and other handling of technical and technological laboratory and manufacturing equipment for the manufacture of bacteriological (biological) or toxin weapons and their means of delivery, and the design, construction and use of workplaces for their production, including the promotion or financing of such activities, shall be prohibited.
(3) The development, manufacture, acquisition, accumulation and possession of biological agents or toxins of such species and in such quantities as do not meet the need for their use for preventive, protective or other peaceful purposes shall be prohibited.
(1) The finding of material or items which may be believed to be a bacteriological (biological) or toxin weapon, or that they may contain a high risk or risk biological agent or toxin, as well as the suspected treatment of prohibited information or suspected promotion or financing of activities under § 4, shall be required to notify without undue delay to the police of the Czech Republic, who shall communicate that information without undue delay to the Office.
(2) Paragraph 1 shall apply mutatis mutandis to the finding of an installation.
(3) Anyone who does not have a permit issued by the Office pursuant to Article 6 (1) and accidentally isolates or detects a high-risk biological agent or toxins in his activity shall be required to notify the Authority without undue delay.
(4) The Office shall ensure that the materials, goods and equipment referred to in paragraphs 1 to 3 are disposed of. The costs are borne by the State. This shall be without prejudice to liability for damage under specific legislation.
(5) Anyone who discovers the loss of a high risk or risk biological agent or toxin or the intentional damage to technical or technological equipment referred to in the declaration referred to in Article 16 or 17 or the declared Office shall be required to notify that fact without undue delay to the Police of the Czech Republic, who shall communicate this information without undue delay to the Office.
(6) Each person shall be obliged to notify the Office within 5 days if he or she enters into service of an establishment which:
(a) is kept under pressure against the surrounding area;
(b) be equipped with a warning system to detect unacceptable changes in air pressure;
(c) the exhaust air is filtered with high efficiency microparticle capture filters (HEPA filters);
(d) is gasible; and
(e) has a validated waste disposal system.
USE OF THE HIGH RISK BIOLOGICAL AGENTS AND TOXINS
Treatment of high-risk biological agents and toxins
(1) The treatment of high-risk biological agents and toxins in the territory of the Czech Republic is subject to authorisation by the Office.
(a) industrial, agricultural, research, health, pharmaceutical and other peaceful purposes;
(b) for protective purposes directly related to the defence against bacteriological (biological) or toxin weapons;
(c) to prevent, identify, diagnose and treat diseases caused by biological agents or toxins.
(2) Authorisations issued by the Office under this Act do not replace authorisations issued under specific legislation.2)
(3) No authorisation is required for the handling of:
(a) high-risk biological agents or toxins in rescue and disposal work (10);
(b) a diagnostic sample containing a high-risk biological agent or a culture of high-risk biological agents derived from that sample for a period of less than 30 days in a reference or diagnostic laboratory pursuant to a specific legislation11);
(c) a highly risk biological agent contained in the vaccine, unless the vaccine is used for research purposes,
(d) the high risk toxin contained in the diagnostic kit by the end user; a diagnostic kit means veterinary preparedness (12) or a medical medium (13) intended for distribution with an integral part of a biological agent or toxin used in the diagnosis of human or animal diseases or for the determination of the presence of biological agents or toxin in the sample taken; Article 17 to 17c shall apply mutatis mutandis to such disposal; and
(e) a high risk toxin contained in certified reference material under the Metrology Act.
(4) The list of high-risk biological agents and toxins is laid down in implementing legislation.
(5) Those who, without authorisation, handle a high-risk biological agent or toxin as referred to in paragraph 3 (a) shall report such treatment to the Authority without undue delay.
Conditions for authorisation to handle high risk biological agents or toxins
(1) Authorisation to handle high-risk biological agents or toxins (hereinafter referred to as "authorisations") The Office shall issue to a legal or natural person, provided that:
(a) the applicant has its registered office in the Czech Republic, if he is a legal person or if he is a natural person,
(b) the applicant, if it is for a natural person, is fully independent and fair;
(c) natural persons who are members of the statutory body of the applicant are fully independent and fair,
(d) the applicant who is a legal person and the legal person who is a member of the statutory body of the applicant shall be fair,
(e) a natural person who is a representative of a legal person who is a member of the statutory body of the applicant shall be fully independent and fair,
(f) establish an expert representative who is required to ensure the proper execution of activities related to the authorised treatment of a high-risk biological agent or toxin; the expert representative must be fully competent, sound and competent,
(g) the authorisation under Article 12 (4) (a) and (b) has not been revoked.
(2) Compliance with paragraph 1 (a) is not required for legal persons having their registered office and natural persons residing in the territory of a Member State of the European Union.
(3) Compliance with paragraph 1 (f) is not required for a natural person who is competent.
(4) The function of an expert representative may always be performed by one person.
integrity
(1) For the purposes of this law, a person who has not been convicted of a criminal offence committed for negligence, the nature of which relates to the activity authorised, or to an offence committed intentionally, shall be deemed to be righteous.
(2) The proof of integrity is:
(a) an extract from the record of the criminal record of the person to whom the condition of integrity referred to in Article 7 (1) applies; or
(b) a similar proof of integrity issued by a competent authority of a Member State of the European Union, of which a natural person, a statutory authority, a member of a statutory authority or an expert representative is a national or in whose territory a legal person has its registered office; where such documents are not issued by that State, they may be replaced by a declaration of honour made before the competent authority or notary of that State; an alien who is or has been a national of another Member State of the European Union or has or has had an address in another Member State of the European Union may, instead of a proof of integrity issued by a competent authority of another Member State of the European Union, provide proof of integrity by means of an extract from the Register of Penalties with an annex containing information entered in the criminal record of another Member State of the European Union2a).
(3) The proof of integrity referred to in paragraph 2 (b) may not exceed 3 months.
(4) In order to demonstrate integrity, the Office shall request, in accordance with the Special Legislation (2a), an extract from the Register of Penalties. An application for an extract from the Register of Penalties and an extract from the Register of Penalties shall be sent in electronic form in a way that allows remote access.
Professional competence
(1) Professional competence means experience in the field of at least 3 years and well completed higher education obtained in the field of study
(a) general medicine or pharmacy;
(b) veterinary medicine or veterinary hygiene;
(c) chemistry or biology, ecology and the environment;
(d) teaching with a focus on chemistry or biology; or
(e) agriculture or food industry.
(2) In recognition of professional qualifications acquired in another Member State of the European Union, another Contracting State of the Agreement on the European Economic Area or in the Swiss Confederation for the pursuit of the activities referred to in Article 7 (1) (f), the Office shall act in accordance with the law on the recognition of professional qualifications.
(3) Education documents issued abroad shall be accompanied by a notation clause in accordance with specific legislation and, in the case of higher education documents, by a certificate of recognition of the equivalence of education in accordance with specific legislation.
(4) The obligation to submit documents bearing a notation clause or certificate of recognition of the equivalence of education referred to in paragraph 3 shall not apply to educational documents issued in a Member State of the European Union, in another Contracting State of the Agreement on the European Economic Area or in the Swiss Confederation or submitted by a natural person from that State.
(5) Where an applicant for an authorisation who is a national of a Member State of the European Union, of another Contracting State of the Agreement on the European Economic Area or of the Swiss Confederation intends to pursue an activity subject to an authorisation temporarily or occasionally, the Office shall carry out an examination of his professional qualifications under the conditions laid down by the Law on the Recognition of Professional Qualifications.
Application for authorisation
(1) The application for authorisation shall contain:
(a) the birth number, if assigned, or the date of birth of the natural person who is:
1. the applicant,
2. a member of the statutory body of the applicant who is a legal person; or
3. a representative of a legal person who is a member of the statutory body of an applicant who is a legal person;
(b) the name, quantity and purpose of high-risk biological agents or toxins and the description of their handling;
(c) the place where the authorised activity is carried out, if it differs from the applicant's registered office or permanent residence.
(2) The application for authorisation must be supported by:
(a) evidence demonstrating the competence of a natural person or the competence of experts;
(b) technical documentation, including a construction plan, a specification of operations and installed technical and technological laboratory and manufacturing equipment and a housekeeping decision;
(c) by a report approved by the public health authority responsible for the place of activity under specific legislation, 3)
(d) a statement that no decision on bankruptcy has been taken concerning the assets of a legal person;
(e) other documents as required by the Office;
(f) where the applicant's integrity is certified by a document referred to in Article 8 (2) (b), that document shall be attached to the application.
(3) The application for authorisation must be made on a form. The model form for the application for authorisation shall be laid down in the implementing legislation.
Decision granting an authorisation
(1) The Office shall proceed in the administrative procedure for the issue of an authorisation, independently of the procedure conducted by another administrative authority. The applicant shall be the sole party to the proceedings.
(2) The Authority shall decide on the granting of the authorisation within 90 days of the initiation of the procedure.
(3) The decision granting the authorisation shall specify:
(a) the business firm or name, registered office and identification number of the legal person requesting authorisation and the name and surname, permanent residence of the person or persons who are a statutory authority or its member;
(b) the name and surname and residence of the natural person and the surname and residence of his or her professional representative, where provided for;
(c) the subject matter and scope of the authorisation for disposal;
(d) the type and quantity of high-risk biological agents or toxins that can be handled;
(e) the conditions under which high-risk biological agents or toxins may be handled.
(4) The application for authorisation shall be rejected if the applicant fails to comply with the conditions laid down in this Act or if the total quantity of high-risk biological agents or toxin is exceeded for a certain period in the Czech Republic; the total quantity of high-risk biological agents or toxins for a certain period on the territory of the Czech Republic, which may not be exceeded, shall be provided for in the implementing legislation.
New authorisation decision, revocation and termination of authorisation
(1) If the information contained in the decision granting the authorisation or other facts relevant to the exercise of the activity authorised is changed, the Authority shall, at the request of the holder of the authorisation, issue a new decision.
(2) The original Decision shall be repealed by a new decision adopted pursuant to paragraph 1.
(3) Where the Authority has been informed of a change to the information contained in the decision granting the authorisation or other facts relevant to the exercise of the activity authorised and the authorisation holder has not submitted an application for a new decision, the Authority shall invite it to submit an application; to this end it shall set a time limit which shall not be less than 5 working days from the date of receipt of the call.
(4) The Office shall revoke the authorisation if the holder of the authorisation:
(a) obtained authorisation on the basis of false or incomplete data;
(b) fails to fulfil its obligations under this law or to remedy deficiencies identified by the Office;
(c) no longer fulfils the conditions applicable to its issue;
(d) has requested the revocation of the authorisation in writing; or
(e) has not requested a new decision in response to the Office's request under paragraph 3.
(5) If the holder of the authorisation does not intend to continue to carry out the authorised activity, he shall notify the Office without undue delay and at the same time request the revocation of the authorisation.
(6) The authorisation expires
(a) the date of death or death of the holder;
(b) a declaration of bankruptcy in respect of the property of the holder of the authorisation; or
(c) a decision by the Office to revoke the authorisation.
(7) The authorisation holder shall, without undue delay after the termination of the authorisation, be obliged to terminate the authorised activity in accordance with this Act.
(8) An appeal against a decision to revoke an authorisation shall not have suspensory effect.
Obligations of authorisation holders
The authorisation holder shall in particular:
(a) dispose of high-risk biological agents and toxins only to the extent specified in the authorisation;
(b) to allow entry into the workplace of inspectors of the Office, international inspectors and persons invited by the Office and to inform them of the extent of the activities currently carried out and of the security measures necessary for carrying out the inspection;
(c) allow inspectors to place monitoring devices to monitor high risk biological agents and toxins and to take samples for analysis;
(d) inform the Authority without undue delay of the initiation of insolvency proceedings;
(e) inform the Office, without undue delay, of the change of an expert representative, if any, and of any other important change that has taken place in the course of the activity authorised, in particular:
1. change in the terms of the permit;
2. organisational change,
3. change of technical or technological laboratory and manufacturing equipment of the workplace,
(f) the planned change in the performance of the authorised activity referred to in (e) to report to the Office at least 30 days before its implementation;
(g) in the event of the destruction of high-risk biological agents or toxins, proceed in a manner which does not pose a risk to human or animal health or to the environment;
(h) to provide a high risk biological agent or toxin only to an authorisation holder pursuant to Article 6 (1), unless the Authority provides otherwise for a limited period of time in an exceptional case, and at the same time the purpose of this law is not compromised;
(i) inform and document carriers of high-risk biological agents or toxins of the nature of the goods entrusted to them and of the safe way of handling them;
(j) lay down requirements to ensure the proper performance of activities related to the authorised management of a high-risk biological agent or toxin, including the obligation to provide a continuous overview of the state of conduct of such activities by the expert;
(k) in the event of the termination and cancellation of the authorisation without undue delay, ensure the transfer of a high-risk biological agent or toxin to another authorisation holder or its destruction; and
(l) without undue delay, notify the Authority of the release of high-risk biological agents or toxins into the environment.
Transport
(1) The transport of high-risk biological agents and toxins can only be carried in the transport packaging and in a manner laid down by specific legislation governing the transport of dangerous items (14).
(2) The carrier must ensure that a consignment containing a high-risk biological agent or toxin is transported, stored during transport and transmitted to the consignee in a manner preventing theft, misuse and loss and must ensure that the unauthorised person does not come into contact with it.
Export and import of high-risk biological agents and toxins
(1) Only the authorisation holder can export from the territory of the Czech Republic and import to the territory of the Czech Republic high risk biological agents and toxins. Such authorisation shall not replace a licence issued under a specific legislation. 6)
(2) Exports of high-risk biological agents and toxins by the authorisation holder are only possible for the purposes referred to in Article 6 (1).
(3) Imports of high-risk biological agents and toxins by the authorisation holder are only possible for the purposes set out in Article 6 (1).
(4) Exports and imports of high-risk biological agents and toxins in the form of consignments addressed to a storage site, customs warehouse, free zone or to an address other than that specified in the authorisation are prohibited.
(5) The holder of the authorisation shall notify the Office of the entry into or leaving the territory of the Czech Republic of high risk biological agents or toxins within 5 days of the date of implementation. The notification shall be transmitted electronically.
(6) The notification referred to in paragraph 5 shall include:
(a) the type and quantities of high-risk biological agents or toxins imported or exported;
(b) the name, surname, telephone number and e-mail address of the natural person responsible for importing or exporting the authorisation holder;
(c) the business firm or the name and address of the legal person or the name, surname, date of birth and place of permanent residence of the natural person who is the supplier of, or recipient of, high risk biological agents or toxins abroad;
(d) the date of import or export;
(e) the company or name and identification number of the carrier; and
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Regulation Information
| Citation | Act No. 281 / 2002 Coll., on certain measures related to the prohibition of bacteriological (biological) and toxin weapons and on the amendment of the Trade Act |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 28.06.2002 |
|---|---|
| Effective from | 28.06.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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