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1. ------IND- 2016 0688 CZ - EN- ------ 20170116 --- --- PROJET  
III. 
D r a f t 
 
ACT  
 
of ………………. 2016,  
 
amending Act No  281/2002 on certain measures related to the prohibition of 
bacteriological (biological) and toxin weapons and on amendments to the Trading  Act, 
as amended  
 
Parliament has adopted the following Act of the Czech Republic:  
 
Article I  
Act No  281/2002 on certain measures related to the prohibition of bacteriological 
(biological) and toxin weapons and on amendments to the Trading Act, as amended b y Act 
No 186/2004, No  413/2005, No  296/2007, No  124/2008, No  223/2009, No  227/2009, 
No 64/2014 and No  243/2016, is amended as follows:  
1. § 2, including the title and footnotes  10 to 12, shall read as follows:  
„§ 2 
Definition of certain terms  
For the purposes  of this Act, the following definitions shall apply  
a) biological agent means any microorganism, such as bacteria, virus, mycoplasm, 
rickettsiae, chlamydiae or fungi, whether natural or modified, either in the form of an 
isolated live culture or as a subst rate including living material which has been 
deliberately inoculated or contaminated with such culture,  
b) toxin means a toxic chemical substance produced through metabolic pathways of 
organisms, including microorganisms, whether natural, modified, or che mically 
synthesised, which can cause death, disease or otherwise harm humans, animals or 
plants;such a chemical substance shall not be considered to be a toxin if present in a 
diagnostic sample or existing as a natural contaminant in another material,  
c) bacteriological (biological) and toxin weapon means  
1. a weapon whose destructive effect is based on the properties of biological agents 
and toxins that harm the health or cause the death of humans or animals, or damage 
plants or cause economic damage,  
2. any device, equipment, apparatus or means designed for delivery or use of 
biological agents or toxins for hostile purposes or in armed conflict or a carrier of 
biological agents deliberately infected for hostile purposes or for use in armed 
conflict,  
d) high-risk biological agents and toxins mean biological agents and toxins that have such 
properties or potential that they can be applied as a weapon;a list of high -risk biological 
agents and toxins shall be established in implementing legislation,   - 2 - 
e) risky bi ological agents and toxins mean biological agents and toxins that may be 
handled under certain conditions;a list of risky biological agents and toxins shall be 
established in implementing legislation,  
f) diagnostic kit means a veterinary medicinal product10) or medicinal product11) intended 
for distribution, an integral part of which is a biological agent or toxin and which is used 
in the diagnosis of human or animal diseases or to determine the presence of a 
biological agent or toxin in a sample,  
g) produc tion means the cultivation of replicative biological agents by any means, or the 
synthesis, biosynthesis or extraction of non -replicative biological agents or toxins,  
h) handling of high -risk biological agents and toxins means the development, production, 
use, acquisition, retention, import, export, transport and destruction of high -risk 
biological agents and toxins;the handling of high -risk biological agents and toxins shall 
not be considered to be a service under the Free Movement of Services Act,  
i) hand ling of risky biological agents and toxins means the development, production, use, 
acquisition, retention, import, export, transport and destruction of risky biological 
agents and toxins;the handling of risky biological agents and toxins shall not be 
consi dered to be a service under the Free Movement of Services Act,  
j) international inspector means the designated representative of an international 
organisation conducting inspection activities to review the implementation of the 
Convention on the Prohibitio n of the Development, Production and Stockpiling of 
Bacteriological (Biological) and Toxin Weapons and on Their Destruction (hereinafter 
referred to as the ‘Convention’)12), 
k) prohibited information means information directly enabling the development or 
production of bacteriological (biological) and toxin weapons, high -risk biological 
agents and toxins, and  
l) handling of prohibited information means collecting, for purposes other than 
prophylactic, protective and other peaceful purposes, providing, whethe r for 
consideration or not, or making publicly available of prohibited information.  
  
10) Act No  166/1999 on veterinary care and on amendments to certain related acts 
(Veterinary Act), as amended.  
11) Act No  268/2014 on medicinal products and on amendments  to Act No  634/2004 on 
administrative fees, as amended.  
12) Convention on the Prohibition of the Development, Production and Stockpiling of 
Bacteriological (Biological) and Toxin Weapons and on Their Destruction promulgated 
under No  96/1975.”.  
2. In § 3(2)(d) , point  1 shall read as follows:  
“1. holders of permits issued under this Act and their professional representatives and”.  
3. In § 3(2), point (e) shall read as follows:  
“e) keep records of  
1. high-risk and risky biological agents and toxins,  
2. facilities where hi gh-risk and risky biological agents and toxins are handled, and  
3. technical and technological equipment of the facilities in accordance with point  2,”.  - 3 - 
4. In § 3(2), at the end of point (e), the full stop shall be replaced by a comma and the 
following point ( f) shall be added:  
“(f) ensure international cooperation in its field of competence and provide information 
related to the implementation of the Convention in its field of competence.”.  
5. In § 3, the following new paragraph  (3) shall be inserted after paragrap h (2): 
“(3) The records kept under paragraph  (2)(d) shall be public.The records kept under 
paragraph  (2)(e) shall be non -public.On request, the Office shall issue a complete or partial 
extract from its records kept under paragraph  2(d) to persons who can d emonstrate a legal 
interest therein.Instead of issuing an extract, information from the information system may 
be provided in a manner allowing remote access.”.  
 
Paragraph  (3) shall become paragraph  (4). 
6. § 4 shall read as follows:  
„§ 4 
(1) The development,  production, acquisition, stockpiling, retention, processing, use, 
consumption, import, export, transport and distribution of bacteriological (biological) and 
toxin weapons or other handling of bacteriological (biological) and toxin weapons and 
handling of  prohibited information, including the provision of support or funding for these 
activities, shall be prohibited.  
(2) The development, production, acquisition, stockpiling, retention, import, export, 
distribution and other handling of technical and technol ogical laboratory and production 
equipment, or the design, construction and use of facilities, for the production of 
bacteriological (biological) or toxin weapons and their delivery systems, including the 
provision of support or funding for these activitie s, shall be prohibited.  
(3) Development, production, acquisition, stockpiling and retention of biological agents 
or toxins of types and in quantities that have no justification for prophylactic, protective or 
other peaceful purposes, shall be prohibited.”.  
7. § 5(1) shall read as follows:  
“(1) Any person who discovers materials or objects that could be assumed to be 
bacteriological (biological) and toxin weapons or to contain high -risk or risky biological 
agents or toxins or has a suspicion that prohibited inf ormation is being handled or support or 
funding is being provided for the activities referred to in §  4 shall, without undue delay, 
report them to the Police of the Czech Republic, which shall then, without undue delay, 
forward this information to the Offi ce.”.  - 4 - 
8. In § 5(3), the word “immediately” shall be replaced by the words “without undue 
delay”.  
9. In § 5, the following new paragraphs  (5) and (6) shall be added after paragraph  (4): 
„(5) Any person who becomes aware of a loss of high -risk or risky biological agents or 
toxins or deliberate damage to technical or technological equipment referred to in a 
declaration or notified to the Office shall report this fact without undue delay to the Police of 
the Czech Republic, which shall, without undue delay, forward t his information to the 
Office.  
(6) The Office shall be notified within five days by any person who puts into service a 
facility that  
a) is maintained under negative pressure against the ambient environment,  
b) is equipped with a warning system to detect un acceptable changes in air pressure,  
c) is using HEPA -filtered air extraction,  
d) is sealable for fumigation, or  
e) has a validated waste disposal system.”.  
10. § 6(3), including footnote  13, shall read as follows:  
“(3) No permit shall be required for the handl ing of  
a) high-risk biological agents and toxins in the course of rescue and remedial operations13), 
if notified to the Office without undue delay,  
b) diagnostic samples containing high -risk biological agents or cultures of high -risk 
biological agents obta ined from these sample for a period of less than 30  days in a 
diagnostic laboratory,  
c) high-risk biological agents contained in a vaccine, unless this vaccine is used for 
research purposes,  
d) high-risk biological toxins contained in a diagnostic kit by a n end -user;in this case, the 
procedure referred to in §  17 shall be followed, and  
e) high-risk biological toxins contained in a certified reference material as referred to in 
the Metrology Act.  
  
13) Act No  239/2000 on the integrated rescue system and on a mendments to certain acts, as 
amended.”.  
11. § 7, including the title, shall read as follows:  
„§ 7 
Conditions for issuing permits for the handling of high -risk biological agents and 
toxins  
(1) Permits for the handling of high -risk biological agents and toxins (hereinafter 
referred to as the ‘permit’) shall be issued by the Office to a legal person or an individual 
under the condition that   - 5 - 
a) the legal person’s registered office or the individual’s place of residence is in the Czech 
Republic,  
b) the individual h as full legal capacity and is of good repute,  
c) individuals who are members of the statutory body of the legal person have full legal 
capacity and are of good repute,  
d) the legal person and the legal person who is a member of the statutory body of the le gal 
person are of good repute,  
e) the individual acting as the representative of the legal person who is a member of the 
statutory body of the legal person is of good repute,  
f) a professional representative has been designated who shall ensure the proper 
performance of the activities related to the permitted handling of high -risk biological 
agents and toxins;the professional representative shall have full legal capacity, be of 
good repute and be professionally competent,  
g) the permit referred to in §  12(4)(a) and (b) has not been revoked.  
(2) Compliance with the condition under paragraph  (1)(a) shall not be required for legal 
persons with registered office or individuals with permanent residence in a Member State of 
the European Union.  
(3) Compliance with the condition under paragraph  (1)(f) shall not be required for 
individuals who are professionally competent.  
(4) Professional representatives may act as such only for one individual or legal person.  
(5) The provisions of paragraph  (1) and paragraph  (2) sha ll apply mutatis mutandis to 
organisational units of the state and their designated employees.”.  
12. In § 8(2)(a), the word “responsible” shall be replaced by the word “professional” and 
the words “legal persons” shall be added after the word “individuals,”.  
13. In § 8(2), point (b) shall read as follows:  
“b) similar proof of good repute issued by the competent authority of a Member State of the 
European Union of which the individual, statutory body, member of statutory body or 
professional representative is a nati onal or in whose territory the legal person is 
established;where the competent authorities of the state do not issue such documents, these 
may be substituted by a solemn declaration made before the competent authority or a notary 
of a Member State of the E uropean Union.Foreign nationals who are or were nationals of 
another Member State of the European Union or whose place of residence is or was in 
another Member State of the European Union may use an extract from the Criminal Records 
Register with a supplem ent containing the information entered in the criminal register of 
another Member State of the European Union2a) in place of proof of good repute issued by 
the competent authority of a Member State of the European Union.”.  
14. In § 8, the following new paragra ph shall be inserted after paragraph  (2): 
“(3) Proof of good repute referred to in paragraph  (2)(b) shall not be older than 
three  months.”   - 6 - 
 
Paragraph  (3) shall become paragraph  (4). 
15. § 9, including the title, shall read as follows:  
„§ 9 
Professional compete nce 
(1) Professional competence means experience in the field of at least three years and 
duly completed higher education in a study programme on  
a) general medical practice or pharmacology,  
b) veterinary medicine or veterinary hygiene,  
c) chemistry, biology, ecolo gy and the environment,  
d) teaching, with a focus on chemistry or biology, or  
e) agriculture or food industry.  
(2) In the recognition of professional qualifications obtained in another Member State of 
the European Union, another state that is a contracting party  to the Agreement on the 
European Economic Area or in the Swiss Confederation for the performance of activities 
referred to in §  7(1)(f), the Office shall proceed in accordance with the Recognition of 
Professional Qualifications Act.The Office’s decision r ecognising professional 
qualifications shall serve as proof of professional competence under this Act.  
(3) In accordance with other legislation, evidence of education issued abroad shall be 
accompanied by a nostrification clause and evidence of higher educ ation shall be 
accompanied by a certificate of recognition of equivalence.  
(4) The obligation to present evidence accompanied by a nostrification clause or 
certificate of recognition of equivalence referred to in paragraph  (3) shall not apply to 
evidence o f education issued in, or presented by an individual from, a Member State of the 
European Union, another state that is a contracting party to the Agreement on the European 
Economic Area or the Swiss Confederation.  
(5) Where a permit applicant, who is a nat ional of a Member State of the European 
Union, another state that is a contracting party to the Agreement on the European Economic 
Area or the Swiss Confederation, intends to perform the activity to be permitted on a 
temporary or occasional basis, the Offi ce shall carry out verification of the applicant’s 
professional qualifications under the conditions laid down in the Recognition of Professional 
Qualifications Act.”.  
16. § 10(1) shall read as follows:  
“(1) The permit application shall include  
a) the personal num ber, if assigned, or date of birth of the individual, who is  
1. the applicant,  
2. a member of the statutory body of an applicant who is a legal person, or  
3. a representative of a legal person that is a member of the statutory body of an 
applicant who is a legal pe rson,  
b) the name, quantity and purpose and description of handling high -risk biological agents 
or toxins,   - 7 - 
c) the place of performance of the activity to be permitted, if other than the applicant’s 
registered office or place of residence.”.  
17. In § 10(2)(a), the wo rd “responsible” shall be replaced by the word “professional”.  
18. In § 10(2)(b), the word “equipment” shall be replaced by the words “technical and 
technological laboratory and production equipment”.  
19. In § 10(2)(d), the words:“and that a bankruptcy filing has not been rejected due to the 
fact that the person’s property is not sufficient to cover the costs of bankruptcy 
proceedings” shall be deleted.  
20. In § 10, the following new paragraph  (3) shall be inserted after paragraph  (2): 
“(3) The permit application shall  be filed on a form.The standard permit application form 
shall be set out by the Office in implementing legislation.”.  
21. In § 11(3)(a) and (b), the words “personal number” shall be deleted.  
22. In § 11(3)(b), the word “responsible” shall be replaced by the word “professional”.  
23. In §  11, paragraph  (4), including footnote  4, shall be deleted.Paragraph  (5) shall 
become paragraph  (4). 
24. § 12, including the title, shall read as follows:  
„§ 12  
New decision to issue a permit and revocation and lapse of a permit  
(1) The Office shall commence new proceedings and issue a new permit decision  
a) on a reasoned request of the permit holder, or  
b) if the facts on the basis of which the original permit was issued have changed.  
(2) The original decision shall be revoked through the new decision is sued in 
accordance with paragraph  (1). 
(3) In the proceedings under paragraph  (1)(b), the party to the proceedings shall submit 
on request of the Office documents necessary to issue the new decision providing proof of a 
change in the facts based on which the o riginal decision was issued and compliance with the 
conditions laid down by law.  
(4) The Office shall revoke a permit whose holder  
a) has obtained the permit on the basis of false or incomplete information,  
b) fails to fulfil the obligations laid down by this Act or  fails to remedy deficiencies found 
by the Office,   - 8 - 
c) no longer satisfies the conditions relevant to the issue of the permit, or  
d) has requested revocation of the permit.  
(5) Permit holders not intending to continue to perform the permitted activity shall 
notify th e Office of this fact without undue delay and, at the same, request revocation of the 
permit.  
(6) A permit shall lapse  
a) on the date of dissolution of the legal person or death of the individual,  
b) upon declaration of the permit holder’s bankruptcy, or  
c) on the date  the Office’s decision to revoke the permit becomes final.  
(7) After the revocation of the permit becomes final, the permit holder shall, without 
undue delay, cease to perform the permitted activity in accordance with this Act.  
(8) Appeals against decisions to rev oke a permit shall not have suspensory effect.”.  
25. In § 13(b), the word “, lost” shall be inserted after the words “be misused” and the 
words “and undertake the security arrangements referred to in §  14a” shall be inserted 
after the words “or stolen”.  
26. In § 13(c), the words “set time limits” shall be replaced by the words “set time limit”.  
27. § 13)(d) shall read as follows:  
“d) allow access to the facility by the Office’s inspectors, international inspectors and 
persons invited by the Office and provide a briefin g on the scope of activities being carried 
out and the security arrangements necessary to exercise control,”  
28. In § 13, at the end of point (f), the full stop shall be replaced by a comma and the 
following points (g) to (n) shall be added:  
“g) inform, withou t undue delay, the Office of a change of the professional representative, 
if designated, and other important changes that have occurred in respect of performing 
the permitted activity, in particular  
1. changes in the conditions for the issue of the permit,  
2. organisational changes,  
3. changes in the facility’s technical or technological equipment,  
h) notify the Office of any planned changes in the performance of the permitted activity in 
accordance with point (g) no later than 30  days before implementing them,  
i) when de stroying high -risk biological agents and toxins, proceed in a manner that does 
not pose a risk to human or animal health or to the environment,  
j) provide high -risk biological agents and toxins only to holders of a permit under §  6(1), 
unless, in exceptional circumstances and for a limited period of time, the Office decides 
otherwise and unless the purpose of this Act is being jeopardised,  
k) inform carriers of high -risk biological agents and toxins of the nature and safe handling 
of the goods in their custody an d make a record that this information has been provided,  
l) lay down through internal rules the requirements for ensuring the proper performance of 
activities related to the permitted handling of high -risk biological agents and toxins,  - 9 - 
including the obligatio n to ensure that the professional representative maintains a 
constant overview of the status of performance of these activities,  
m) when the permit is revoked or lapsed, ensure, without undue delay, that high -risk 
biological agents and toxins are handed over to another permit holder or destroyed, and  
n) notify the Office of a release of high -risk biological agents and toxins into the 
environment without undue delay.”.  
29. § 13a, including the title and footnote  14, shall read as follows:  
“§ 13a 
Transport  
(1) High -risk bi ological agents and toxins may only be transported in transport 
packaging, in the manner laid down in special legislation14). 
(2) Carriers shall ensure that shipments containing high -risk biological agents and 
toxins are transported, stored whilst in transit a nd transferred to the recipient in such a way 
as to prevent theft, misuse or loss and shall ensure that unauthorised persons do not come 
into contact with them.  
  
14) For example,European Agreement concerning the International Carriage of Dangerous 
Goods b y Road (ADR) No  64/1987, as amended.”.  
30. In § 14(2), the words “to the State Parties to the Convention and only” shall be deleted 
and the words “paragraph  (1)” shall be added at the end of the paragraph.  
31. In § 14(3), the words “from the State Parties to the C onvention and only” shall be 
deleted and the words “paragraph  (1)” shall be added at the end of the paragraph.  
32. § 14(5) shall read as follows:  
“(5) Permit holders shall notify the Office within five days of high -risk biological 
agents and toxins entering or  leaving the territory of the Czech Republic.The notification 
shall be transmitted electronically.”.  
33. In § 14, the following new paragraphs  (6) to (8) shall be added after paragraph  (5): 
“(6) The notification referred to in paragraph  (5) shall include  
a) the type and quantity of high -risk biological agents and toxins imported or exported,  
b) first name, surname, telephone number and e -mail address of the individual arranging 
for the import or export for the permit holder,  
c) the business name or name and registered o ffice of the legal person or first name, 
surname, date of birth and place of residence of the individual who is the supplier or 
recipient abroad of high -risk biological agents and toxins,  
d) the date of import or export,  
e) the business name or name and identifi cation number of the carrier, and  
f) the customs office conducting the import or export customs procedure.   - 10 - 
(7) A standard form for the notification referred to in paragraph  (5) shall be set out by 
the Office in implementing legislation.  
(8) When high -risk biological agents and toxins are exported, the permit holder shall 
keep a written declaration of the foreign end -user that the high -risk biological agents and 
toxins will not be used for the production or development of biological weapons giving the 
specific purpose of using them.”.  
34. § 14a shall be inserted after §  14, which shall, including the title, read as follows:  
“§ 14a 
Security of high -risk biological agents and toxins  
(1) Permit holders shall protect high -risk biological agents and toxins and equipment 
for the prod uction thereof against loss, theft and misuse, in particular by technical means or 
by means of surveillance.  
(2) Permit holders shall store high -risk biological agents and toxins in a locked room 
with walls, ceiling, floor, windows and doors that are made of a  penetration -proof material, 
or in a non -portable lockable box or a special lockable laboratory cabinet designed for this 
purpose.  
(3) Permit holders shall ensure that only persons designated by them enter 
unaccompanied the room where high -risk biological agen ts and toxins stored.Keys or other 
means of access to this room shall be kept separately from the keys or other means of access 
to other rooms.  
(4) Permit holders shall compile and keep up -to-date a list of persons who have access 
to high -risk biological agent s and toxins.  
(5) Permit holders operating a facility referred to in §  5(6), where high -risk biological 
agents and toxins are handled, shall compile a list of persons who have access to this 
facility.  
(6) Permit holders shall ensure that any person who has access to high -risk biological 
agents and toxins receives annual training on securing high -risk biological agents and toxins 
against misuse, loss or theft.”.  
35. In § 16(1), the words “the records shall be archived for a period of 10  years from the 
lapse of the permi t to handle high -risk biological agents or toxins” shall be deleted.  
36. In § 16(2), the words “facilities in which” shall be replaced by the words “facilities 
where”.  
37. In § 16(4), the words “and estimate data for the following calendar year by 31  August 
of the  given year” shall be deleted.   - 11 - 
38. § 16(5) shall read as follows:  
“(5) The declaration shall include  
a) the type and quantity of all high -risk biological agents and toxins handling of which is 
permitted,  
b) the name and location of the facility where the declared ac tivity is carried out,  
c) technical and technological laboratory and production equipment of the facility referred 
to in (b) and  
d) information as to whether the handling of high -risk biological agents or toxins is part of 
national defence or security research.” . 
39. In § 16(6), the words “, the period of retention of the records” shall be inserted after 
the words “record -keeping”.  
40. The following paragraph  (7) shall be added in §  16: 
“(7) A standard form for the declaration shall be set out by the Office in implementi ng 
legislation.”.  
41. § 17, including the group heading, shall read as follows:  
“Risky biological agents and toxins  
§ 17 
(1) Risky biological agents and toxins may be handled within the territory of the Czech 
Republic only for  
a) industrial, agricultural, research , medical, pharmaceutical and other peaceful purposes,  
b) protection purposes that are directly related to the defence against bacteriological 
(biological) and toxin weapons,  
c) prevention, identification, diagnostics and treatment of diseases caused by bi ological 
agents or toxins.  
(2) Individuals or legal persons handling risky biological agents and toxins shall report 
to the Office data for the preceding calendar year by 31  January of the following year in the 
form of a declaration.  
(3) The declaration shall incl ude 
a) the type and quantity of all notified risky biological agents and toxins,  
b) the facility where the declared activity is carried out,  
c) technical and technological laboratory and production equipment of the facilities 
referred to in (b) and  
d) information as t o whether the handling of risky biological agents and toxins is part of 
national defence or security research.”.  
(4) Individuals or legal persons intending to handle risky biological agents and toxins 
for the first time shall comply with the notification oblig ation no later than 14  days prior to 
handling them.   - 12 - 
(5) The notification obligation under paragraph  (4) shall not apply to the handling of  
a) risky biological agents and toxins in the course of rescue and remedial operations13), 
provided that these are notifie d to the Office without undue delay,  
b) diagnostic samples containing risky biological agents or cultures of risky biological 
agents obtained from these sample for a period of less than 30  days in a diagnostic 
laboratory,  
c) risky biological agents contain ed in a vaccine, unless this vaccine is used for research 
purposes,  
d) risky biological toxins contained in a certified reference material as referred to in the 
Metrology Act.  
(6) The notification referred to in paragraph  (4) shall include  
a) the type of the risk y biological agent and toxin, and  
b) the data referred to in paragraph  (2)(b) and (c).”.  
42. New §  17a and §  17b shall be inserted after §  17, which shall, including the title, read 
as follows:  
 
“§ 17a 
(1) The notification obligation shall also apply to the insta llation of new technical and 
technological laboratory and production equipment.  
(2) Standard forms for the declaration referred to in §  17(2) and the notification referred 
to in §  17(4) shall be set out by the Office in implementing legislation.  
(3) The pr ovisions of §  16 shall apply mutatis mutandis to record -keeping of risky 
biological agents and toxins.The details of record -keeping, the period of retention of records 
and the data to be included in the declaration shall be set out by the Office in impleme nting 
legislation.  
(4) Legal persons and individuals handling risky biological agents and toxins shall 
notify the Office within fives days of risky biological agents and toxins entering or leaving 
the territory of the Czech Republic.The notification shall be transmitted electronically.  
(5) The notification referred to in paragraph  (4) shall include  
a) the type and quantity of risky biological agents and toxins imported or exported,  
b) first name, surname, telephone number and e -mail address of the individua l arranging 
for the import or export for the person handling risky biological agents and toxins,  
c) the business name or name and registered office of the legal person or first name, 
surname, date of birth and place of residence of the individual who is th e supplier or 
recipient abroad of risky biological agents and toxins,  
d) the date of import or export,  
e) the business name or name and identification number of the carrier, and  
f) the customs office conducting the import or export customs procedure.  
(6) A  standard form for the notification referred to in paragraph  (4) shall be set out by 
the Office in implementing legislation.   - 13 - 
(7) When risky biological agents and toxins are exported, the person handling the risky 
biological agents and toxins shall keep a w ritten declaration of the foreign end -user that the 
risky biological agents and toxins will not be used for the production or development of 
biological weapons giving the specific purpose of using them.  
(8) Risky biological agents and toxins may only be tr ansported in transport packaging, 
in the manner laid down in special legislation14). 
 
§ 17b 
Securing risky biological agents and toxins  
 
Any person handling risky biological agents and toxins shall  
c) ensure that risky biological agents and toxins are secured  against loss, misuse or theft, 
in particular by technical means,  
d) ensure that high -risk biological agents and toxins are destroyed in a manner that does 
not pose a risk to human or animal health or to the environment,  
e) notify the Office without undue delay of a release of risky biological agents and toxins 
into the environment,  
f) ensure that persons who have access to risky biological agents and toxins receive annual 
training on securing risky biological agents and toxins against misuse, loss and theft, 
and 
g) inform the Office without undue delay of changes in the performance of the notified 
activity, in particular organisational changes and changes in technical or technological 
equipment of the facility.”.  
43. In the heading of TITLE  V, the word “supervision” shall be replaced by the word 
“control”.  
44. The title of §  18 shall read:“Control”.  
45. In § 18(1), the words “(hereinafter referred to as ‘supervision’)” shall be deleted.  
46. In § 18(3), the word “Supervision” shall be replaced by the word “Control”.  
47. The following paragr aph (4) shall be added in §  18: 
“(4) The inspector's authority to conduct control shall have the form of an 
identification card issued by the Office.The identification card shall contain  
a) name or, if applicable, names and surname of the inspector,  
b) the date and place of birth of the inspector,  
c) a photograph or other form of visual identification of the inspector,  
d) the inspector’s signature,  
e) the date of issue of the identification card, and  
f) the name and address of the seat of the Office.”.   - 14 - 
48. In § 19(1), the word “ immediately” shall be replaced by the words “without undue 
delay”.  
49. In § 19(1), the words “or risky” shall be inserted after the words “high -risk”.  
50. In § 19, paragraph  (2) shall be deleted and paragraph (1) shall become unnumbered.  
51. In § 20, the words “chairp erson of the Office” shall be deleted.  
52. In § 20(b), the words “equipment or parts, system or sets thereof” shall be replaced by 
the words “technical and technological laboratory and production equipment”.  
53. New heading “Offences” shall be inserted before §  21. 
54. § 21 shall read as follows:  
„§ 21  
(1) Individuals, legal persons or sole traders will commit an offence by  
a) breaching the prohibition of development, production, acquisition, stockpiling, 
retention, processing, use, consumption, import, export, transport or d istribution of 
bacteriological (biological) and toxin weapons or other handling of bacteriological 
(biological) or toxin weapons, or handling of prohibited information, including the 
provision of support or funding for these activities, as referred to in §  4(1),  
b) breaching the prohibition of development, production, acquisition, stockpiling, 
retention, import, export, distribution or other handling of technical and technological 
laboratory and production equipment, or the design, construction and use of faci lities, 
for the production of bacteriological (biological) or toxin weapons and their delivery 
systems, including the provision of support or funding for these activities, as referred to 
in § 4(2),  
c) breaching the prohibition of development, production, acqu isition, stockpiling and 
retention of biological agents or toxins of types and in quantities that have no 
justification for prophylactic, protective or other peaceful purposes, as referred to in 
§ 4(3),  
d) failing to inform the Police of the Czech Republic of  any of the facts referred to in 
§ 5(1) or (5),  
e) failing to inform the Office of any of the facts referred to in §  5(3),  
f) failing to inform the Office of any of the facts referred to in §  5(6), or  
g) handling high -risk biological agents or toxins without a perm it from the Office as 
referred to in §  6. 
(2) Fines of up to the following amounts may be imposed for the offences under 
paragraph  (1) 
a) CZK  50 000 000, for the offences referred to in paragraph  (1)(a) to (c),  
b) CZK  10 000 000, for the offence referred to in parag raph (1)(g),  
c) CZK  500 000, for the offence referred to in paragraph  (1)(f), or   - 15 - 
d) CZK  100 000, for the offences referred to in paragraph  (1)(d) or (e).”.  
55. The following new §  21a to §  21e shall be inserted after §  21: 
“§ 21a 
(1) Individuals, legal persons or sole t raders who are holders of the permit under this 
Act, will commit an offence by  
a) handling high -risk biological agents or toxins in a scope other than that defined in the 
permit,  
b) handling high -risk biological agents or toxins in such a way that they can be mi sused, 
lost or stolen or by failing to undertake the security arrangements in accordance with 
§ 13(b),  
c) failing to present to the Office the declaration referred to in §  13(c) within the set time 
limit,  
d) failing to provide assistance to the Office in accorda nce with §  13(d) or (e),  
e) failing to inform the Office without undue delay of any of the facts referred to in §  13(f) 
to (h) or (n), or in §  14(5),  
f) proceeding contrary to §  13(i) when destroying high -risk biological agents or toxins,  
g) providing high -risk bio logical agents or toxins to a person contrary to §  13(j),  
h) failing to inform carriers of high -risk biological agents or toxins of the facts referred to 
in § 13(k) or failing to make a record that this information has been provided,  
i) failing to lay down throu gh internal rules the requirements referred to in §  13(l),  
j) failing to hand over to another permit holder or destroy high -risk biological agents or 
toxins without undue delay when the permit is revoked or lapsed as referred to in 
§ 13(m), or  
k) transporting hi gh-risk biological agents or toxins contrary to §  13a(1).  
(2) Individuals, legal persons or sole traders who are holders of the permit under this 
Act, will commit an offence by  
a) exporting or importing high -risk biological agents or toxins for a purpose other th an 
those referred to in §  14(2) or (3),  
b) failing to keep the written declaration of the foreign end -user referred to in §  14(8) 
when exporting a risky biological agent or toxin,  
c) failing to ensure protection of high -risk biological agents or toxins or equipm ent for the 
production thereof against loss, theft and misuse as referred to in §  14a(1),  
d) failing to store high -risk biological agents or toxins in accordance with §  14a(2),  
e) failing to ensure that only persons designated by the permit holder enter unaccomp anied 
the room where high -risk biological agents and toxins stored or failing to ensure that the 
keys or other means of access are stored in accordance with §  14a(3),  
f) failing to compile or keep up -to-date a list of persons who have access to high -risk 
biological agents or toxins as referred to in §  14a(4),  
g) failing to compile or keep up -to-date a list of persons who have access to a facility 
holding high -risk biological agents or toxins as referred to in §  14a(5), or  
h) failing to ensure that persons who have a ccess to high -risk biological agents or toxins 
receive annual training in accordance with §  14a(6).  
(3) Individuals, legal persons or sole traders who are holders of the permit under this 
Act, will commit an offence by   - 16 - 
a) failing to keep record of the handling of  high-risk biological agents or toxins or failing 
to present the records on the Office’s request in accordance with §  16(1),  
b) failing to hand over all records of the handling of high -risk biological agents or toxins to 
the Office upon the lapse or revocatio n of the permit in accordance with §  16(3), or  
c) failing to present to the Office the declaration referred to in §  16(4).  
(4) Fines of up to the following amounts may be imposed for the offences under 
paragraphs  (1) to (3)  
a) CZK  10 000 000, for the offence referre d to in paragraph  (2)(a),  
b) CZK  1 000 000, for the offences referred to in paragraph  (1)(a), (b), (d), (i) to (k), 
paragraph  (2)(c) to (e) or paragraph  (3)(a),  
c) CZK  500 000, for the offence referred to in paragraph  (1)(c), (e) to (h) or paragraph  2(f) 
to (h),  or paragraph(3)(b) or (c), or  
d) CZK  100 000, for the offence referred to in paragraph  (2)(b).  
§ 21b 
(1) Individuals, legal persons or sole traders handling risky biological agents or toxins 
will commit an offence by  
a) failing to report to the Office any of the fa cts referred to in §  17(2), §  17a(4) or §  17b(c),  
b) failing to comply with the notification obligations referred to in §  17(4) or §  17a(1),  
c) failing to keep record of the handling of risky biological agents or toxins in accordance 
with §  17a(3),  
d) failing to ke ep the written declaration of the foreign end -user referred to in §  17a(7) 
when exporting a risky biological agent or toxin,  
e) transporting risky biological agents or toxins contrary to §  17a(8),  
f) failing to ensure that risky biological agents and toxins are secured against loss, misuse 
or theft in accordance with §  17b(a),  
g) failing to destroy risky biological agents or toxins in accordance with §  17b(b),  
h) failing to ensure that persons who has access to risky biological agents or toxins receive 
annual training in accordance with §  17b(d), or  
i) failing to inform the Office without undue delay of any organisational changes or 
changes in technical or technological equipment of the facility.  
(2) Fines of up to the following amounts may be imposed for the offences under 
paragraph  (1) 
a) CZK  500 000, for the offences referred to in paragraph  (1)(a) to (c), (e) to (g) or (i),  
b) CZK  200 000, for the offence referred to in paragraph  (1)(h), or  
c) CZK  100 000, for the offence referred to in paragraph  (1)(d).  
§ 21c 
(1) Individuals, legal per sons or sole traders who are carriers of high -risk biological 
agents or toxins will commit an offence by failing to ensure that  
a) shipments containing high -risk biological agents or toxins are transported, stored whilst 
in transit or transferred to the recip ient in such a way as to prevent theft, misuse or loss 
in accordance with §  13a(2), or  
b) no unauthorised persons come into contact with a shipment containing high -risk 
biological agents or toxins in accordance with §  13a(2).  
(2) A fine of up to CZK  100 000 may b e imposed for the offences referred to in 
paragraph  (1).  - 17 - 
§ 21d 
(1) The limitation period shall be five years.Where the limitation period has been 
interrupted, the liability for the offence shall not lapse before 10  years after it was 
committed.  
(2) Offences under this Act shall be dealt with by the Office.  
(3) Fines for offences shall be collected by the Office.  
(4) The amounts of fines for offences under this Act shall be doubled where the same 
offence has been committed repeatedly.An offence shall be deemed to have been committed 
repeatedly if less than one year has passed since the date on which the decision imposing a 
fine for the same offence became final.  
§ 21e 
Use of data to exercise state authority in the area of the prohibition of bacteriological 
(biological) and t oxin weapons  
(1) The Office shall use the following data to exercise state authority in the area of the 
prohibition of bacteriological (biological) and toxin weapons  
a) reference data from the basic population register,  
b) data from the population register informati on system and  
c) data from the information system on foreign nationals.  
(2) The data used under paragraph  1(a) shall include  
a) surname,  
b) name or, if applicable, names,  
c) date, place and district of birth;  in the case of data subjects born abroad, date, place and 
count ry of birth,  
d) address of the place of residence,  
e) date, place and district of death;  in the case of the data subject’s death outside the 
territory of the Czech Republic, the date of death and the place and country in which the 
death occurred;  if a court deci sion on the declaration of death has been issued, the date 
stated in the decision as the date of death or the date which the data subject declared 
dead did not survive, and the date on which this decision became final,  
f) citizenship or, if applicable, citize nships.  
(3) The data used under paragraph  1(b) shall include  
a) name or, if applicable, names, surname and name at birth,  
b) date of birth,  
c) gender,  
d) place and district of birth;  in the case of individuals born abroad, the country of birth,  
e) personal number,  
f) citizenshi p or, if applicable, citizenships,  
g) date, place and district of death;  in the case of the individual’s death outside the territory 
of the Czech Republic, the date of death and the place and country in which the death 
occurred.  
(4) The data used under paragraph  1(c) shall include  
a) name or, if applicable, names, surname and name at birth,  
b) date of birth,   - 18 - 
c) gender,  
d) place and country of birth of the foreign national,  
e) personal number,  
f) citizenship or, if applicable, citizenships,  
g) type and address of the place of residence  in the territory of the Czech Republic,  
h) date, place and district of death;  in the case of death outside the territory of the Czech 
Republic, the country in which the death occurred and the date of death and the date 
stated in the court decision on the dec laration of death as the date of death or, if 
applicable, the date the foreign national declared dead did not survive.  
(5) The data maintained in the basic population register as reference data shall be 
obtained from the population registration information sys tem or the information system on 
foreign nationals only if they are in the format preceding the currently applicable format.  
(6) In each particular case, the data provided may be used only to the extent necessary 
to accomplish the given task.”.  
56. § 22(1) shall r ead as follows:  
“(1) The Office shall issue an implementing decree to implement §  2(d) and (e), §  10(3), 
§ 11(4), and §  14(7), §  16(6) and (7), §  17a(2), (3) and (6)”.  
57. In § 22, paragraph  (2) shall be deleted.  
Paragraphs  (3) to (6) shall become paragraphs  (2) to (5).  
 
Article  II 
Transitional provisions  
1. Legal persons or individuals handling high -risk biological agents and toxins or risky 
biological agents and toxins as of the date of entry into force of this Act shall adapt 
their legal arrangements to Act No  281/2002 as in force from the date of entry into 
force of this Act within six months of the date of entry into force of this Act.  
2. For persons who are handling high -risk biological agent and toxins on the date of entry 
into force of this Act on the basis of  a permit exclusively for the purpose referred to in 
§ 6(3)(d) and who, in accordance with §  6(3), no longer need a permit for this activity, 
the notification obligation referred to in §  17(3) shall be considered fulfilled.  
 
Article  III 
Notification  
This A ct was notified in accordance with Directive (EU) 2015/1535 of the European 
Parliament and of the Council of 9  September  2015 laying down a procedure for the 
provision of information in the field of technical regulations and of rules on Information 
Society  services.   - 19 - 
Article  IV 
Entry into force  
This Act shall enter into force on 1  January  2018.