SECURITIES (INSIDER DEALING) ORDINANCE ——附加英文版
Hong Kong
SECURITIES (INSIDER DEALING) ORDINANCE
(CHAPTER 395)
ARRANGEMENT OF SECTIONS
ion
I PRELIMINARY
hort title
nterpretation
pplication
Connected with a corporation"
ossession of relevant information obtained in privileged
capacity
Dealing in securities"
Take-over offer"
Relevant information"
II INSIDER DEALING
hen insider dealing takes place
Certain persons not to be held insider dealers
Trustees and personal representatives
Exercise of right to subscribe for or acquire securities
Duty of officers of corporation
Insider dealing not void or voidable
III INSIDER DEALING TRIBUNAL
Constitution of Tribunal Inquiries by Tribunal
Inquiries into insider dealing
Powers of Tribunal
Further powers of Tribunal to obtain information
Incriminating answers
Offences
Privileged information Report and orders of Tribunal
Report of Tribunal following inquiry
Orders etc. of Tribunal
Order against officer of corporation
Limitation on aggregate amount of penalties
Witnesses' expenses
Expenses of investigation and inquiry
Form and proof of order of Tribunal
Order of Tribunal may be registered in Court
Offence
IV APPEALS
Appeal to Court of Appeal
Powers of the Court of Appeal on appeal
Stay of execution on appeal
V MISCELLANEOUS
Offences by corporation, etc.
Limitation on commencement of proceedings
Chief Justice may make rules
44. (Omitted)
Whole document:
dule.
rdinance to amend the law relating to insider dealing in
securities;
for connected purposes.
eptember 1991] L. N. 269 of 1991
PART I PRELIMINARY
hort title
Ordinance may be cited as the Securities (Insider Dealing)
Ordinance.
nterpretation
In this Ordinance, unless the context otherwise requires--
ociate", in relation to a person entitled to exercise or control
the
cise of voting power in relation to a corporation, means--
that person's spouse, reputed spouse, person co-habiting
with that
on as a spouse, that person's brother, sister, parent,
step-parent,
d (natural or adopted) or step-child;
any corporation of which that person is a director;
any person who is an employee or partner of that person;
if that person is a corporation--
any director of that corporation;
any related corporation of that corporation; and
) any director or employee of any such related corporation; and
if that person has with any other person an agreement or
arrangement
respect to the acquisition, holding or disposal of shares or
other
rests in that corporation or under which they undertake
to act
ther in exercising their voting power in relation to it, that
other
on;
k or other document" includes--
books of a banker;
cheques, orders for the payment of money, bills of
exchange, and
issory notes in the possession or under the control of a banker;
securities in the possession or under the control of a banker,
whether
ay of pledge or otherwise;
any document or record used in the ordinary course of business
of a
;
any record so used which is kept otherwise than in a legible form
and
apable of being reproduced in a legible form; and
any accounts or deeds;
mission" means the Securities and Futures Commission
established by
Securities and Futures Commission Ordinance (Cap. 24);
pany" means a company as defined in section 2 (1) of the
Companies
nance (Cap. 32);
troller", in relation to a corporation, means any person--
in accordance with whose directions or instructions the
directors of
corporation or of another corporation of which it is a subsidiary
are
stomed to act; or
who, either alone or with any associate, is entitled to exercise,
or
rol the exercise of, more than 33% of the voting power at
general
ings of the corporation or of another corporation of which it
is a
idiary, and references in this Ordinance to "control"
shall be
trued accordingly; "corporation" means any company or
other body
orate or an unincorporated body, incorporated or formed either
in Hong
or elsewhere;
ector" includes--
any person occupying the position of director, by
whatever name
ed; and
any person in accordance with whose directions or
instructions the
ctors of the corporation are accustomed to act;
ument" includes any register, book, record, tape recording, any
form
omputer input or output, and any other document or similar
material
ther produced mechanically, electrically, or manually, or by any
other
s whatsoever);
h Court" means the High Court of Justice;
ding company" means a corporation which is a holding company
within
meaning of section 2 of the Companies Ordinance (Cap. 32);
uiry" means an inquiry instituted under section 16;
ider dealer" means a person who perpetrates any act which
is an
der dealing within the meaning of section 9 and also means a
person
is to be regarded as an insider dealer under section 16 (6);
ider dealing" means an insider dealing within the meaning of
section
ted securities" means securities that are listed on the
Unified
ange at the time of any insider dealing in relation
to those
rities;
icer" in relation to a corporation includes a director,
manager or
etary, and in relation to an unincorporated body includes every
member
he governing body thereof; "related corporation", in relation
to a
oration, means--
any corporation that is that corporation's subsidiary or
holding
any or a subsidiary of that corporation's holding company;
any corporation a controller of which is also a controller of
that
oration; "relevant share capital" means a corporation's issued
share
tal of a class carrying rights to vote at general meetings
of the
oration;
urities" means any shares, stocks, debentures, loan stocks,
funds,
s, or notes of, or issued by, any body, whether
incorporated or
corporated, or of any government or local government authority,
and
udes--
rights, options, or interests (whether described as
units or
rwise) in or in respect of any of the foregoing;
certificates of interest or participation in, or temporary or
interim
ificates for, receipts for, or warrants to subscribe to or
purchase,
of the foregoing; or
any instruments commonly known as securities;
sidiary" means any corporation which is a subsidiary
within the
ing of section 2 of the Companies Ordinance (Cap. 32);
bunal" has the meaning given to it in section 15;
fied Exchange" means the stock market established under section
27 of
Stock Exchanges Unification Ordinance (Cap. 361).
For the purpose of the definition of "controller", where a
person is
tled to exercise or control the exercise of 33% or more of the
voting
r at general meetings of a corporation and that
corporation is
tled to exercise or control the exercise of any of the voting power
at
ral meetings of another corporation ("the effective voting
power")
the effective voting power at general meetings of
that other
oration is taken as exercisable by that person.
A person shall not be deemed to be a person in accordance with
whose
ctions or instructions the directors of a corporation are
accustomed
ct by reason only that the directors of the corporation act on
advice
n by him in a professional capacity.
In this Ordinance securities are deemed to be listed on the
Unified
ange notwithstanding that dealings in such securities
have been
ended.
In this Ordinance a reference to an interest in securities is
to be
as including an interest of any kind whatsoever in the
securities;
accordingly there are to be disregarded any restraints or
restrictions
hich the exercise of any right attached to the interest
may be
ect.
pplication
Ordinance shall not have effect with respect to an insider dealing
in
tion to the listed securities of a corporation which has taken
place
re the commencement of this Ordinance.
Connected with a corporation"
A person is connected with a corporation for the purposes of
section 9
being an individual--
he is a director or employee of that corporation or a
related
oration; or
he is a substantial shareholder in the corporation or a
related
oration; or
he occupies a position which may reasonably be expected to give
him
ss to relevant information concerning the corporation by virtue
of--
any professional or business relationship existing between
himself (or
employer or a corporation of which he is a director or a firm of
which
s a partner) and that corporation, a related corporation or an
officer
ubstantial shareholder in either of such corporations; or
his being a director, employee or partner of a
substantial
eholder in the corporation or a related corporation; or
he has access to relevant information in relation to the
corporation
irtue of his being connected (within the meaning of paragraph (a),
(b)
c)) with another corporation, being information which relates
to any
saction (actual or contemplated) involving both those
corporations or
lving one of them and the listed securities of the other or to
the
that such transaction is no longer contemplated; or
he was at any time within the 6 months preceding any
dealing in
tion to listed securities within the meaning of section 9 a
person
ected with the corporation within the meaning of paragraph (a),
(b),
or (d).
A corporation is a person connected with a corporation
for the
oses of section 9 so long as any of its directors or employees
is a
on connected with that other corporation within the
meaning of
ection (1).
In subsection (1), "substantial shareholder" in
relation to a
oration means a person who has an interest in the relevant
share
tal of that corporation which has a nominal value equal to or
more
10% of the nominal value of the relevant share capital of
that
oration.
ossession of relevant information obtained in privileged
capacity
A public officer or a member or employee (whether such
member or
oyee is temporary or permanent, paid or unpaid) of any body
referred
n subsection (2), who in his capacity as such receives
relevant
rmation concerning a corporation shall be deemed to be a
person
ected with that corporation for the purposes of section 9.
The bodies referred to in subsection (1) are--
the Executive Council;
the Legislative Council;
the Futures Exchange Company, Stock Exchange Company or any
clearing
e;
any board, commission, committee or other body appointed by
or on
lf of the Governor or the Governor in Council under any Ordinance;
any body corporate established or incorporated by Ordinance; and
any body corporate specified by the Financial Secretary by
notice
ished in the Gazette.
In this section--
aring house" means a clearing house within the meaning of section
2
of the Commodities Trading Ordinance (Cap. 250) or authorized
under
other Ordinance to carry on business as a clearing house in
respect of
rities;
ures Exchange Company" means the Exchange Company within the
meaning
ection 2 (1) of the Commodities Trading Ordinance (Cap. 250);
ck Exchange Company" means the Exchange Company within the
meaning of
ion 2 (1) of the Stock Exchanges Unification Ordinance (Cap. 361).
In the case of a body referred to in subsection (2) which
has no
ers the reference in subsection (1) to a member shall be construed
as
ference to a member of the governing body thereof.
Dealing in securities"
the purposes of this Ordinance, a person deals in securities if
ther as principal or agent) he buys, sells, exchanges or
subscribes
or agrees to buy, sell, exchange or subscribe for, any securities
or
ires or disposes of, or agrees to acquire or dispose of, the right
to
sell, exchange or subscribe for, any securities.
Take-over offer"
his Ordinance, "take-over offer for a corporation" means an offer
made
ll the holders (or all the holders other than the person making
the
r and his nominees) of the shares in the corporation to acquire
those
es or a specified proportion of them, or to all the holders (or
all
holders other than the person making the offer and his nominees)
of a
icular class of those shares to acquire the shares of that class
or a
ified proportion of them.
Relevant information"
his Ordinance "relevant information" in relation to a
corporation
s specific information about that corporation which is not
generally
n to those persons who are accustomed or would be likely to deal
in
listed securities of that corporation but which would if
it were
rally known to them be likely materially to affect the price of
those
rities.
PART II INSIDER DEALING
hen insider dealing takes place
Insider dealing in relation to the listed securities of a
corporation
s place--
when a person connected with a corporation who is in
possession of
rmation which he knows is relevant information in relation to
that
oration deals in any listed securities of that corporation (or
in the
ed securities of a related corporation) or counsels or
procures
her person to deal in such listed securities knowing or
having
onable cause to believe that such person would deal in them;
when a person who is contemplating or has contemplated making
(whether
or without another person) a take-over offer for a corporation
and
knows that the information that the offer is contemplated or
is no
er contemplated is relevant information in relation
to that
oration, deals in the listed securities of that corporation (or
in the
ed securities of a related corporation) or counsels or
procures
her person to deal in those listed securities, otherwise than for
the
ose of such take-over;
when relevant information in relation to a corporation is
disclosed
ctly or indirectly, by a person connected with that
corporation, to
her person and the first-mentioned person knows that the
information
elevant information in relation to the corporation and knows
or has
onable cause for believing that the other person will make use
of the
rmation for the purpose of dealing, or counselling or
procuring
her to deal, in the listed securities of that corporation (or in
the
ed securities of a related corporation);
when a person who is contemplating or has contemplated making
(whether
or without another person) a take-over offer for a corporation
and
knows that the information that the offer is contemplated or
is no
er contemplated is relevant information in relation
to that
oration, discloses that information, directly or
indirectly, to
her person and the first-mentioned person knows or has
reasonable
e for believing that the other person will make use of the
information
the purpose in dealing, or in counselling or procuring
another to
, in the listed securities of that corporation (or in the
listed
rities of a related corporation);
when a person who has information which he knows is
relevant
rmation in relation to a corporation which he received
(directly or
rectly) from a person--
whom he knows is connected with that corporation; and
whom he knows or has reasonable cause to believe
held that
rmation by virtue of being so connected,
s in the listed securities of that corporation (or in the
listed
rities of a related corporation) or counsels or procures
another
on to deal in those listed securities;
when a person who has received (directly or indirectly) from a
person
he knows or has reasonable cause to believe is contemplating or
is no
er contemplating a take-over offer for a corporation,
information to
effect and knows that such information is relevant
information in
tion to that corporation, deals in the listed securities
of that
oration (or in the listed securities of a related
corporation) or
sels or procures another person to deal in those listed
securities.
An insider dealing in relation to the listed
securities of a
oration also takes place when a person who is knowingly in
possession
elevant information in relation to that corporation in any
of the
umstances described in subsection (1) --
counsels or procures any other person to deal in the listed
securities
hat corporation (or in the listed securities of a related
corporation)
he knowledge or with reasonable cause to believe that, that
person
d deal in those listed securities outside Hong Kong on any
stock
ange other than the Unified Exchange; or
discloses that relevant information to any other person
in the
ledge or with reasonable cause to believe that, that or some
other
on will make use of that information for the purpose of dealing,
or of
selling or procuring any other person to deal, in
the listed
rities of that corporation (or in the listed securities of a
related
oration) outside Hong Kong on any stock exchange other
than the
ied Exchange.
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关于《境内第三类、境外医疗器械注册审批操作规范（试行）》的通告
国家食品药品监督管理局
关于《境内第三类、境外医疗器械注册审批操作规范（试行）》的通告
国食药监械[2005]75号
根据《医疗器械监督管理条例》、《医疗器械注册管理办法》，国家食品药品监督管理局制定了《境内第三类、境外医疗器械注册审批操作规范（试行）》。现予通告。
国家食品药品监督管理局
二○○五年二月十八日
境内第三类、境外医疗器械注册审批操作规范（试行）
境内第三类、境外医疗器械注册审批工作由受理、技术审评、行政审批环节构成。
受理由国家食品药品监督管理局医疗器械技术审评中心受理办负责；技术审评由国家食品药品监督管理局医疗器械技术审评中心负责；行政审批由局机关负责。
一、受理办
1．受理
受理办接收申报单位所提出的属于本部门职权范围的注册申请项目，当场或者5个工作日内做出如下处理：一次性告知申请人需要补正的全部内容并开具《补正材料通知书》；符合要求的发给《受理通知书》；不属于本部门职权范围的开具《不予受理通知书》。
2．录入（2个工作日）
3．录入后，对于需要进行技术审查的材料，将材料转技术审评中心（2个工作日）。
4．受理材料时的核查要点：见《境内第三类、境外医疗器械注册申报资料受理标准》。
5．对于技术审评中心认为不合格、需补充材料的，受理办应及时发“补充材料通知单”，并接收补充材料，转交技术审评中心（申报单位接到“补充材料通知单”及受理办收到补充材料后，均须在2个工作日内转交）。
6．对于技术审评完毕，结论为“基本合格”，需补充材料的，受理办发补充通知单，接收补充材料后，将材料转局医疗器械司注册处（申报单位接到“补充材料通知单”后，须在2个工作日内发出；受理办收到补充材料后，需转交的，须在2个工作日内转交）。不能判定补充材料是否符合技术审评要求的，注明情况，将材料转技术审评中心（须在2个工作日内转交），由技术审评中心判定资料的合格性。
7．受理办接到局医疗器械司注册处转交的行政审批结束的材料后，6个工作日内完成打印注册证、盖章、发布批件工作（不计入审批时限）。
8．证书发放完毕的材料，转交技术审评中心档案室（在1个月内完成）。
二、技术审评中心技术审评（50个工作日）
技术审评中心接到需要技术审评的申请材料，进行技术审评。审评要求见“审评细则”。
技术审评中心办公室在收到受理办转来的材料后，2个工作日内将审评项目分发到各处室。
1．主审人审评（工作时限：36个工作日）：负责对申报资料的实质性审查并填写技术审查报告。
2．复审人复审（工作时限：5个工作日）：对主审人出具的技术审查报告进行复审，并写出复审意见。
3．中心主任签发（工作时限：5个工作日）：对复审人复审后的技术审查报告进行确认，签发最终技术审查报告。
技术审评中心主任签发后，审评中心办公室在2个工作日内将技术审评结论为合格或者退审的材料转局医疗器械司注册处；结论为基本合格的材料转受理办；技术审评认为需进一步补充材料的，将补充通知单转受理办。
三、行政审批（注册项目：32个工作日，注册证变更、补证项目：14个工作日）
1．.医疗器械司注册处经办人：复核经过技术审评的项目，经办注册证变更、补证等其它项目（注册项目：7个工作日，注册证变更、补证项目：4个工作日）。
经办要点：
（1）技术审查报告
（2）申报单位、生产企业的诚信情况
（3）是否涉及我局或其他机关部门处理的案件
（4）是否有投诉、举报情况
（5）上报批件内容的复核及确定
（6）经办人复核意见（意见与技术审评结论不一致时，应提交正式的申述报告）
（7）审查注册证变更、补证的材料
2．医疗器械司注册处处长复核要点：（注册项目：7个工作日，注册证变更、补证项目：4个工作日）
（1）技术审查结论
（2）经办人意见
3．医疗器械司司长复核要点：（注册项目：8个工作日，注册证变更、补证项目：6个工作日）
（1）处长意见
（2）经办人意见
（3）签字（应由国家食品药品监管局局长签发产品）或签发（境内、境外产品重新注册，境外第一、二类产品注册）
4．国家食品药品监管局局长复核要点：（8个工作日）
（1）行政审查意见
（2）签发
国家食品药品监管局局长签发后的材料，2个工作日内转医疗器械司注册处；审批后的材料，医疗器械司注册处在2个工作日内转交受理办。