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| Assisted
human
reproduction
policy
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20. (1) The Minister is responsible for the
policy of the Government of Canada
respecting assisted human reproduction and
any other matter that, in the opinion of the
Minister, relates to the subject-matter of this
Act.
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| Agency
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(2) The Minister is responsible for the
Agency.
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| Agency
established
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21. (1) The Assisted Human Reproduction
Agency of Canada is hereby established as a
body corporate that may exercise powers and
perform duties only as an agent of Her Majesty
in right of Canada.
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| Head office
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(2) The head office of the Agency shall be
at a place in Canada designated by the
Governor in Council.
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| Application of
Official
Languages
Act
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(3) The Official Languages Act applies to
the Agency.
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| Objectives
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22. The objectives of the Agency are
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(a) to protect and promote the health and
safety, and the human dignity and human
rights, of Canadians, and
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(b) to foster the application of ethical
principles,
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in relation to assisted human reproduction and
other matters to which this Act applies.
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| Principles
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23. The Agency shall exercise its powers in
a manner consistent with the principles set out
in section 2.
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| Powers of
Agency
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24. (1) The Agency may
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(a) exercise the powers in relation to
licences under this Act;
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(b) provide advice to the Minister on
assisted human reproduction and other
matters to which this Act applies;
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(c) monitor and evaluate developments
within Canada and internationally in
assisted human reproduction and other
matters to which this Act applies;
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(d) consult persons and organizations
within Canada and internationally;
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(e) collect, analyse and manage health
reporting information relating to controlled
activities;
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(f) provide information to the public and to
the professions respecting assisted human
reproduction and other matters to which
this Act applies, and their regulation under
this Act, and respecting risk factors
associated with infertility;
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(g) designate inspectors and analysts for the
enforcement of this Act; and
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(h) do anything that is reasonably necessary
or incidental to achieving the Agency's
objectives.
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| Advice to
Minister
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(2) On request by the Minister, the Agency
shall provide
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(a) advice on issues pertaining to assisted
human reproduction and other matters that
the Minister considers appropriate;
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(b) health reporting information, other than
the identity of any person - or information
that can reasonably be expected to be used
in the identification of any person; and
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(c) information concerning the general
administration and management of the
Agency's affairs.
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| Policy
directions
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25. (1) The Minister may issue policy
directions to the Agency concerning the
exercise of any of its powers, and the Agency
shall give effect to directions so issued.
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| Exception
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(2) Policy directions issued by the Minister
may not affect a matter that is before the
Agency at the time they are issued and that
relates to a particular person.
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| Statutory
Instruments
Act
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(3) Policy directions issued by the Minister
are not a statutory instrument for the purposes
of the Statutory Instruments Act.
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| Board of
directors
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26. (1) There shall be a board of directors of
the Agency consisting of not more than 13
members, including a Chairperson and the
President of the Agency.
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| Appointment
criteria
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(2) The membership of the board of
directors must reflect a range of backgrounds
and disciplines relevant to the Agency's
objectives.
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| Part-time
service
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(3) The members of the board of directors
shall perform their duties and functions on a
part-time basis.
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| Term of office
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(4) A member of the board shall be
appointed by the Governor in Council for a
term not exceeding three years. Each initial
member of the board shall be appointed to
hold office for a term that will ensure, so far as
possible, the expiry in any one year of the
terms of office of not more than one third of
the members.
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| Removal and
reappointment
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(5) A member of the board shall be
appointed to hold office during pleasure, and
is eligible for reappointment.
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| Continuation
in office
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(6) If no successor is appointed to take
office on the expiry of a member's term of
appointment, the member continues in office
until a successor is appointed.
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| Provisions not
applicable
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(7) Subsections (3) to (6) do not apply to the
Chairperson or the President.
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| Persons not
eligible to be
directors
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(8) A person is not eligible to be a member
of the board of directors if they hold a licence
or are an applicant for a licence or a director,
officer, shareholder or partner of a licensee or
applicant for a licence.
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| Meetings
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27. The board of directors may determine
the times and the places in Canada of its
meetings, but it shall meet at least twice a year.
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| Participation
of deputy
ministers
|
28. The Deputy Minister of Health, or an
alternate designated by the Deputy Minister of
Health, and a person nominated by the deputy
ministers of the departments responsible for
health in the provinces from among their
number, or an alternate so nominated, are
entitled to attend meetings of the board of
directors and speak to any matter under
consideration at the meeting.
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| Members of
the board
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29. Each member of the board of directors,
except the President of the Agency,
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(a) shall be paid the remuneration fixed by
the Governor in Council for attendance at
meetings of the board of directors or any of
its committees or for the performance of
other duties;
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(b) is deemed to be employed in the public
service of Canada for the purposes of the
Government Employees Compensation Act
and the regulations made under section 9 of
the Aeronautics Act; and
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(c) is entitled to be reimbursed for
reasonable travel and living expenses
incurred by the member in the course of
performing their duties while absent from
their ordinary place of residence.
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| Management
of Agency
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30. The board of directors is responsible for
the overall management of the Agency,
including
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(a) the provision of advice to the Minister
on assisted human reproduction and other
matters to which this Act applies, or on any
matter referred to the Agency by the
Minister;
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(b) the approval of the Agency's goals and
operational policies;
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(c) the approval of the Agency's budget;
and
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(d) the evaluation of the Agency's
performance.
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| By-laws
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31. The board of directors may, with the
approval of the Governor in Council, make
by-laws for the regulation of its proceedings
and generally for the conduct of its activities.
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| Delegation
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32. (1) Subject to subsection (2), the board
of directors may, by by-law, delegate any of
the Agency's powers and duties to a
committee of the board or the President,
including powers and duties under sections
44, 46, 52, 54, 55, 58, 59 and 64.
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| Exceptions
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(2) The board of directors may not delegate
its powers under section 40, 41 or 42 or any of
its powers or duties with respect to the
provision of advice to the Minister, the
approval of the Agency's goals and
operational policies, the approval of its budget
and the making of by-laws.
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| Advisory
panels
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33. (1) The board of directors may, by
by-law, establish advisory panels to examine,
report on and make recommendations with
respect to any issue referred to the panels by
the board.
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| Outside
members
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(2) A by-law establishing an advisory panel
may provide for the inclusion of persons who
are not members of the board.
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| Fees
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(3) Members of an advisory panel who are
not members of the board may be paid
remuneration for their services as fixed by the
Agency's by-laws.
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| Appointment
of
Chairperson
|
34. (1) The Chairperson of the board of
directors shall be appointed by the Governor
in Council to hold office during pleasure for a
term of not more than three years, and is
eligible for reappointment.
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| Functions of
Chairperson
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(2) The Chairperson shall preside at
meetings of the board of directors, and may
exercise the powers and shall perform the
duties assigned by the Agency's by-laws.
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| Election of
Vice-Chairper
son
|
35. (1) The board of directors shall elect one
of its members to be Vice-Chairperson.
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| Replacing
Chairperson
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(2) In the event of the absence or incapacity
of the Chairperson or a vacancy in that office,
the Vice-Chairperson may exercise the
powers and shall perform the duties of the
Chairperson.
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| Appointment
of President
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36. (1) The President of the Agency shall be
appointed by the Governor in Council to hold
office during pleasure for a term of not more
than five years, and is eligible for
reappointment.
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| Chief
executive
officer
|
(2) The President is the chief executive
officer of the Agency and has supervision over
and direction of the work and staff of the
Agency, and may exercise the powers and
shall perform the duties assigned by the
Agency's by-laws.
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| Delegation
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(3) The President may delegate to any
officer of the Agency any power conferred or
duty imposed on the President by or under this
or any other Act.
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| Acting
President
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(4) In the event of the absence or incapacity
of the President or a vacancy in that office, the
board of directors may authorize an officer of
the Agency to act as President, but no person
may act as President for a period exceeding 90
days without the approval of the Governor in
Council.
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| President's
pay and
benefits
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37. The President
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(a) shall be paid the remuneration fixed by
the Governor in Council; and
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(b) is entitled to be reimbursed for
reasonable travel and living expenses
incurred by the President in the course of
performing duties while absent from the
President's ordinary place of work.
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| Exercise of
powers by
officers and
employees
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38. An officer or employee of the Agency
may exercise any power and perform any duty
of the Agency if the officer or employee is
appointed to serve in a capacity appropriate to
the exercise of the power or performance of
the duty.
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| Contracts and
arrangements
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39. (1) The Agency may enter into
contracts, agreements, memoranda of
understanding and other arrangements with a
department or agency of the Government of
Canada, with any other government or any of
its agencies or with any person or
organization, either in its own name or in the
name of Her Majesty in right of Canada.
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| Title to
property
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(2) Property acquired by the Agency is
property of Her Majesty in right of Canada,
and title to it may be held in the Agency's
name or in Her Majesty's name.
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| Legal
proceedings
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(3) Actions, suits or other legal proceedings
in respect of any right or obligation acquired
or incurred by the Agency, whether in its own
name or in the name of Her Majesty in right of
Canada, may be brought or taken by or against
the Agency in the name of the Agency in any
court that would have jurisdiction if the
Agency were not an agent of Her Majesty.
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| Issuance of
licence for
controlled
activity
|
40. (1) The Agency may, in accordance with
the regulations, issue a licence to any person
having the qualifications provided under the
regulations, authorizing the person to
undertake any controlled activity specified in
the licence.
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| Use of in vitro
embryo
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(2) A licence authorizing the use of an in
vitro embryo for the purpose of research may
be issued only if the Agency is satisfied that
the use is necessary for the purpose of the
proposed research.
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| Clinical trials
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(3) The number of licences that the Agency
considers sufficient may be issued in respect
of clinical trials of a controlled activity.
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| Written
consent
required
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(3.1) The Agency shall not issue a licence
under subsection (1) for embryonic stem cell
research unless it has received the written
consent of the original gamete providers and
the embryo provider in accordance with the
Human Pluripotent Stem Cell Research
Guidelines released by the Canadian Institutes
of Health Research in March, 2002, as
specified in the regulations.
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| Responsible
individual
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(4) If a person to whom a licence is issued
is not an individual, the licence must designate
an individual as the person responsible for
compliance with this Act, but that designation
does not affect the responsibility of the
licensee or any other individual under this
Act.
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| Issuance of
facility
licences
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(5) The Agency may, in accordance with the
regulations, issue a licence to the owner or
operator of any premises permitting the use of
those premises for a controlled activity
undertaken by persons to whom a licence has
been issued under subsection (1).
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| Terms and
conditions
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(6) The Agency may, in accordance with the
regulations, attach terms and conditions to a
licence at the time of issuing the licence or at
any time after that.
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| Cost recovery
prohibited
|
(7) The Agency may not apply a policy of
cost recovery to the issuance of licences.
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| Amendment
and renewal
of licences
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41. The Agency may, in accordance with
the regulations, amend a licence or renew an
expiring licence, with or without amendment.
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| Amendment,
suspension or
revocation for
cause
|
42. The Agency may, in accordance with
the regulations, amend, suspend or revoke the
licence of a licensee who contravenes this Act
or the regulations or the terms and conditions
of the licence or who fails to comply with any
measures ordered to be taken under this Act,
and may prescribe conditions for the
restoration of a suspended licence.
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| Matters to be
considered
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43. (1) In exercising its powers under
sections 40 to 42, the Agency may take into
account information and observations offered
by any person and may seek the advice of
persons having expertise related to the
application or of persons representative of any
interest affected by the application.
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| Disclosure
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(2) Subject to subsection (3), the Agency
shall, on request, disclose the information and
observations provided under subsection (1)
unless the disclosure would, in the Agency's
opinion, pose a risk to the health or safety of
any person.
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| Identifying
information
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(3) The identity of - or information that
can reasonably be expected to be used in the
identification of - a donor of human
reproductive material or an in vitro embryo, a
person who has undergone an assisted
reproduction procedure or a person who was
conceived by means of such a procedure may
not be disclosed except to an applicant or
licensee who, in the Agency's opinion,
requires the information to support an
application.
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| Immunity
|
(4) No civil or criminal proceedings may be
brought against any person for offering
information and observations in good faith
under subsection (1).
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| Threats to
health or
safety
|
44. (1) The Agency may take, or order any
person to take, all reasonable measures that
the Agency considers necessary to prevent,
reduce or mitigate any threat to human health
or safety that results, or may reasonably be
expected to result, from a controlled activity.
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| Entry and
management
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(2) For the purposes of taking measures
referred to in subsection (1), the Agency may
authorize an inspector designated under
section 46 to enter the premises where the
controlled activity is being undertaken and to
assume the management of those premises
and that activity.
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| Recovery of
costs
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(3) Any costs incurred by an inspector
acting under this section shall be borne by the
person who holds the licence in respect of the
controlled activity or premises and, until paid,
those costs are recoverable in any court of
competent jurisdiction as a debt due to Her
Majesty in right of Canada.
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