Act No. 253 / 2017 Coll.
Act amending 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, as amended
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Effective from 01.01.2018
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01.01.2018
18.08.2017
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253
THE LAW
of 20 July 2017
amending Act No 281 / 2002 Coll., on certain measures relating to the prohibition of bacteriological (biological) and toxin weapons and amending the Trade Act, as amended
Parliament has decided on this law of the Czech Republic:
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 No. 186 / 2004 Coll., Act No. 413 / 2005 Coll., Act No. 296 / 2007 Coll., Act No. 124 / 2008 Coll., Act No. 223 / 2009 Coll., Act No. 227 / 2009 Coll., Act No. 64 / 2014 Coll., Act No. 243 / 2016 Coll. and Act No. 183 / 2017 Coll., is amended as follows:
1. Paragraph 2, including the title, reads:
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 for collection for purposes other than preventive, protective or other peaceful purposes, the provision or publication of prohibited information. ";
2. in Paragraph 3 (2) (d) (1):
"1. holders of authorisations issued under this Act and their experts; and '.
3. in Article 3 (2) (e):
"(e) keeps records of:
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. ';
4. In Article 3, at the end of paragraph 2, the dot is replaced by a comma and the following point (f) is added:
"(f) international cooperation in its field of competence."
5. In Article 3, the following paragraph 3 is inserted after paragraph 2:
"(3) The records kept pursuant to paragraph 2 (d) shall be 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. ';
Paragraph 3 shall become paragraph 4.
6.
(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, production, 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. "
7. Paragraph 5 (1) reads as follows:
"(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 a suspicion of the treatment of prohibited information or suspicion of supporting or financing activities pursuant to § 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. '
8. In Paragraph 5 (3), "without delay 'is replaced by" without undue delay'.
9. In Article 5, the following paragraphs 5 and 6 are added:
"(5) Any person who discovers the loss of a high-risk or hazardous biological agent or toxin or the intentional damage to technical or technological equipment referred to in the declaration referred to in § 16 or 17 or the declared Office shall be obliged to notify the Police of the Czech Republic without undue delay, which shall communicate this information to the Office without undue delay.
(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. ';
10. Paragraph 6 (3), including footnotes 10 to 13, reads:
"(3) No authorisation for handling
(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.
10) Act No. 239 / 2000 Coll., on an integrated rescue system and amending certain laws, as amended.
11) For example, Act No. 166 / 1999 Coll., on Veterinary Care and on the Amendment of Certain Related Laws (Veterinary Act), as amended, Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Laws, as amended, Act No. 296 / 2008 Coll., on the Quality and Safety of Human Tissue and Cell for Human Use and on the Amendment of Related Laws (Act on Human Tissue and Cell), as amended, Act No. 373 / 2011 Coll., on Specific Health Services, as amended.
12) Act No. 166 / 1999 Coll., on veterinary care and amending certain related laws (Veterinary Act), as amended.
13) Act No. 268 / 2014 Coll., on Medical Devices and amending Act No. 634 / 2004 Coll., on Administrative Charges, as amended. '
11. in Article 6, the following paragraphs 4 and 5 are added:
"(4) The list of high-risk biological agents and toxins shall be established by implementing legislation.
(5) Those who, without authorisation, handle a high-risk biological agent or toxin as referred to in paragraph 3 (a) shall notify the Authority without undue delay. ';
12.
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) Only one person may be employed as an expert representative. "
13. in Article 8 (2) (a), the words "a natural person, a person who is a statutory authority or a member of a statutory authority and an extract from the records of the Register of Penalties of the responsible agent" shall be replaced by the words "a person to whom the condition of integrity referred to in Article 7 (1) applies."
14. in Article 8 (2) (b):
"(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 Uni2'
15. in Paragraph 8, the following paragraph 3 is inserted after paragraph 2:
"(3) The proof of integrity referred to in paragraph 2 (b) may not exceed 3 months."
Paragraph 3 shall become paragraph 4.
16.
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 carry out an activity subject to an authorisation on a temporary or occasional basis, 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. ';
17. Paragraph 10 (1) reads:
"(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 place of residence or permanent residence of the applicant. ";
18. in Paragraph 10 (2) (a), "a" is replaced by "or" and "responsible" is replaced by "professional."
19. in Paragraph 10 (2) (b), "equipment" is replaced by "technical and technological laboratory and manufacturing equipment."
20. In Paragraph 10 (2) (d), the words "or the insolvency application has not been rejected because the property of that person is not sufficient to cover the costs of insolvency proceedings" shall be deleted.
21. In Article 10, the following paragraph 3 is added:
"(3) The application for authorisation shall be made on a form. The model form for the application for authorisation shall be laid down in the implementing legislation. ';
22. in Article 11 (3) (a) and (b), the words "the birth number" shall be deleted;
23. in Article 11 (3) (b), the word "responsible" shall be replaced by "professional."
24. Paragraph 11 (4), including footnote 4, is deleted.
Paragraph 5 shall become paragraph 4.
25. in Article 11 (4), the words "the Office by implementing legislation" shall be replaced by the words "implementing legislation."
26. Paragraph 12, including the title, reads:
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) The appeal against the decision to revoke the authorisation does not have suspensory effect. "
27. in Article 13, points (b) and (c) are deleted;
Points (d) to (f) shall be renumbered (b) to (d).
28. in Paragraph 13 (b):
"(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;"
29. In Article 13, at the end of point (d), the dot is replaced by a comma and the following points (e) to (l) are added:
"(e) without undue delay inform the Office of the change of the expert representative, if any, and of any other important change that has taken place in the course of the authorised activity, 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 Office of the release of high-risk biological agents or toxins into the environment. ';
30.
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.
14) Act No. 111 / 1994 Coll., on Road Transport, as amended. European Agreement on the International Carriage of Dangerous Goods by Road (ADR), published under No 64 / 1987 Coll. Act No. 266 / 1994 Coll., on Railways, as amended. Convention on International Carriage by Rail (COTIF), published under No 8 / 1985 Coll. Act No. 114 / 1995 Coll., on Inland Navigation, as amended. Decree No 222 / 1995 Coll., on waterways, navigation in ports, common accident and transport of dangerous goods, as amended. Act No. 49 / 1997 Coll., on Civil Aviation and amending and supplementing Act No. 455 / 1991 Coll., on Business Business (Trade Act), as amended. European Agreement on the International Carriage of Dangerous Goods by Inland Waterways (ADN), published under No 102 / 2011 Coll. s. '.
31. in Paragraph 14 (2), the words' to the Member States of the Convention and only 'shall be deleted.
32. In Article 14, the text "paragraph 1 'shall be added at the end of the text of paragraph 2.
33. in Paragraph 14 (3), the words' from the Member States of the Convention and only 'shall be deleted.
34. In Paragraph 14, the text "paragraph 1 'shall be added at the end of the text of paragraph 3.
35. in Paragraph 14 (5):
"(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. ';
36. In Paragraph 14, paragraphs 6 to 8 are added:
"(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
(f) the customs office which has conducted the import or export procedure.
(7) The model of the notification referred to in paragraph 5 shall be laid down in an implementing act.
(8) When exporting high-risk biological agents or toxins, the authorisation holder shall have at his disposal a written declaration from the foreign end-user that the high-risk biological agents or toxins will not be used for the manufacture or development of bacteriological (biological) or toxin weapons, indicating the specific purpose of their use. ';
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Regulation Information
| Citation | Act No. 253 / 2017 Coll., amending Act No. 281 / 2002 Coll., on certain measures related to the prohibition of bacteriological (biological) and toxin weapons and amending the Trade Act, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.08.2017 |
|---|---|
| Effective from | 01.01.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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