关于做好统一换发药品批准文号工作的通知
国家药监局
关于做好统一换发药品批准文号工作的通知
国药监注[2001]582号
各省、自治区、直辖市药品监督管理局:
为全面贯彻实施《药品包装、标签和说明书管理规定(暂行)》(第23号局令),统
一药品批准文号,我局于2001年4月下发了《关于贯彻实施23号局令统一药品批准文号
工作的通知》(国药监注〔2001〕187号),对整个工作做了全面的安排。在全国各有关单
位的共同努力下,规范药品包装、标签和说明书的工作取得了一定的进展,目前已进入统
一换发批准文号工作阶段。为做好此项工作,现通知如下:
一、统一换发药品批准文号的范围
此次将对国内药品生产企业所有合法生产的药品批准文号进行换发,包括各药品生产
企业历年经药品监管部门批准的、合法生产的所有药品(含生物制品)(违规审批的药品除
外)。参加化学药品再评价的品种以及中成药地方标准品种和中药保健药品将在完成整顿
工作后一并换发新的药品批准文号。
二、统一换发药品批准文号工作档案规范要求
档案是换发药品批准文号的依据,同时在换发过程中进一步形成的档案将成为合法药
品批准文号溯源的依据。为此,我局药品注册司组织有关人员起草了《统一换发药品批准
文号工作档案规范要求》(见附件1)。请各省、自治区、直辖市药品监督管理局按照要求
进行原始档案的整理工作,为药品批准文号的换发及今后的药品监督管理的工作打下基
础。
三、统一换发药品批准文号工作程序
在广泛征求各方面意见的基础上,我局药品注册司制定了《统一换发药品批准文号工
作程序》(见附件2)。各地要严格按照程序,将规范药品说明书、包装和标签的工作与换
发药品批准文号作为整体工作进行,成熟一批,换发一批。
由于换发药品批准文号工作时间紧,任务重,为保证在2002年3月31日前基本完成,
请各有关单位一定要按程序进行,做到高效、有序,上下一致,如有问题及时与专项工作
小组联系。
附件:1.统一换发药品批准文号工作档案规范要求
2.统一换发药品批准文号工作程序
国家药品监督管理局
二○○一年十二月三十一日
附件1:
统一换发药品批准文号档案基本要求
一、建立和完善审批档案的目的和意义
档案管理,是政府行政行为中一个非常重要的环节,是保证药品研究、生产、临床使
用和市场监督依法行政的重要依据。从1985年7月至今,各省审批的药品已达十多万个
品种规格。由于市场经济的发展,企业改制的加快,政府药品监督管理部门体制的改革,
监督管理主体发生改变,各省原批准文号和审批档案在转移和管理中出现较多的问题。因
此,重新清理、建立、完善和规范药品审批档案,对于药品的监督管理工作,保证统一换
发药品批准文号的顺利进行有着极为重要的意义。
二、档案的要求:
1、一个品种,一个档案。
2、文字资料档案的建立应与电脑信息化相结合进行综合管理(考虑到时间紧迫,可
先建立文字档案,换发批准文号后再建立电脑化管理)。
3、审批文件尽可能以原始批件或相关证明该品种的文件归档。(无原件的,复印件应
注明此件为原件复印件和原件保存地点,并加盖药品注册处公章。)
三、档案的内容:
1、原始生产批件:
(1)1996年5月25日以前批准的仿制药品,尽可能提供原件,如无原件的,可提
供复印件或相关证明。
(2)1996年5月25日后批准的仿制药品应必须提供原件。
2、该品种的历年换发批准文号相关文件的复印件。
3、现行生产质量标准。
4、《药品生产企业许可证》(复印件)。
5、跨省移植中成药品种,应按卫生部(88)卫药政字第166号文规定,提供生产省
药品审批部门的同意移植文件或相关证明。
6、符合23号局令及相应规范细则要求的药品说明书。
7、符合23号局令及相应规范细则要求的药品包装和标签。
8、其他相关审批资料。
附件2:
统一换发药品批准文号工作程序
一.换发原则
将统一换发药品批准文号与规范药品包装、标签和说明书作为整体工作进行,批准文
号的换发要严格按照程序进行,原批准文号须合法,档案应完备,可溯源。成熟一批,换
发一批。
二.组织形式
在药品注册司的领导下,由专项工作小组负责组织、实施批准文号换发的统一工作,
各省级药品监督管理局负责辖区内批准文号换发的基础工作,包括品种的核对、对应和档
案核查。
三.工作程序
1、化学药品由药品注册司将已规范的说明书目录分批下发至各省级药品监督管理局,
同时公布在国家药品监督管理局和中国药品生物制品检定所的网站上,由各省级药品监督
管理局按品种目录通知辖区内相应的药品生产企业进行申报。中药和生物制品由各省级药
品监督管理局自行通知辖区内相应的药品生产企业进行申报。
2、药品生产企业按省级药品监督管理局下发的相应品种目录,填写申请表(见附表
一)与磁盘软件,并将符合国家药品监督管理局《药品包装、标签和说明书管理规定(暂
行)》(第23号局令)及其相应的规范细则要求的药品包装、标签和说明书样稿,一式两份
报辖区省级药品监督管理局。
3、省级药品监督管理局受理企业的申请后,对申请表所填报内容,以及药品包装、
标签和说明书样稿进行审核,并按《换发药品批准文号档案规范要求》建立和完善相应品
种的档案。省级药品监督管理局审核的重点是原生产批件(原生产批件可由企业出示或省
级药品监督管理局档案查询,当与企业复印件核对一致后在企业复印件上加盖公章)及有
关该品种的原始档案。审核通过后填写《换发药品批准文号审核意见》(见附表二)与磁
盘软件,申请表经逐级审核签字与磁盘数据一并报送专项工作小组。
4、专项工作小组对上报的资料进行形式审核,并对报审品种的原始档案进行抽查核
对,审核通过后的品种在网上公布。对于没有争议的品种,将拟换发的药品批准文号、包
装、标签和说明书以及执行标准合并成报批文件,上报国家药品监督管理局药品注册司。
5、药品注册司批准后,将相关批件下发至各省级药品监督管理局,由各省局转发至
相关的药品生产企业。
四.申报资料
1.企业报送资料
(1)申请表
申请表包括两部分:一是企业基本信息部分,一是品种登记表部分。品种登记表按每
品种(含不同规格)填写一张表。
(2)相关资料
* 原生产批件的复印件
* 该品种的历年换发批准文号相关文件的复印件
* 该品种现行质量标准复印件
* 药品生产许可证复印件
* 符合23号局令及相应规范细则要求的说明书样稿
* 符合23号局令及相应规范细则要求的包装、标签样稿
* 其他相关审批资料
注:所有报省级药品监督管理局资料须一式两份。
2.省级药品监督管理局报送资料
(1)省级药品监督管理局审核意见表
(2)附件
* 省级药品监督管理局审核通过的品种目录原件
* 企业申请表原件及所附相关资料
注:药品生产企业申请表程序软盘及省级药品监督局应用的数据库管理与数据采集、
核对软件将通过电子信箱或邮寄方式下发至各省局,各省局将企业申请表程序软盘复制后
下发各药品生产生产企业。
附表一
申请编号:
换发药品批准文号申请表
药品生产企业名称:___________________________
申请日期:_________年_____月_____日
国家药品监督管理局制
填 表 说 明
1.申请编号由省级药品监督管理局在接收企业申请后按下述编号方法编制填写:编号首
位以省的汉字简称开始,第2位紧接代码的是5位以阿拉伯数字书写的、以“0”补位的
流水号。
2.企业名称、注册地址均应按营业执照上的企业名称和地址填写。
3.生产地址和生产范围按《药品生产许可证》上的生产地址填写。
4.药品名称、剂型、规格和包装规格均按现行批件中的相应内容填写,现行批准中未写
明的项目应填“无”。
5.原生产批准文号、批准日期和批准单位是指该品种首次获得生产许可的批准文件的相
应内容。
6.现批准文号、批准日期和批准单位是指最终在药品注册部门注册的批件中的相应内容。
如该品种自首次注册以来未再重新注册过,相应内容填写“无”。
7.“执行标准”按最终注册批件注册的执行标准填写。
8.标准文号指部颁标准中的标准批文号,如无此项或属药典标准则填“无”。
9.“说明”由企业填写该品种的注册历史记录,即自首次注册以来的每次注册时间、注册
原因以及需要说明的问题等内容。
10.“审核结论”是指经对该品种登记信息的审核与注册相关资料的核对后得出的审核结
论。
药品生产企业基本情况登记表
┌─────┬───────────────────────────────┐
│ 企业名称 │ │
├─────┴─┬─────────────────────────────┤
│变更前企业名称│ │
├─────┬─┴─────────────────────────────┤
│ 注册地址 │ │
├─────┼───────────────────────────────┤
│ 生产地址 │ │
├─────┼──────────┬──────┬─────────────┤
│ 法人代表 │ │ 法人代码 │ │
├─────┴────┬─────┴──────┴─────────────┤
│药品生产许可证编号 │ │
├──┬───────┴──────────────────────────┤
│ │ │
│ 生 │ │
│ 产 │ │
│ 范 │ │
│ 围 │ │
│ │ │
├──┴─┬────────────┬────┬──────────────┤
│ 联系人 │ │ 邮编 │ │
├────┼────────────┴────┴──────────────┤
│ 电话 │ │
├────┼────────────┬────┬──────────────┤
│ 传真 │ │电子邮箱│ │
├────┴────────────┴────┴──────────────┤
│ │
│ │
│法人代表签字 日期_________年______月______日 │
│ │
│ │
│ │
│ │
│(单位公章) │
│ │
├────────┬────────┬─────┬─────────────┤
│填表人姓名 │ │ 填表日期 │ │
└────────┴────────┴─────┴─────────────┘
品种登记审核表
┌───────┬─────────────────────────────┐
│药品名称 │ │
├───────┼────────────┬────┬───────────┤
│剂 型 │ │ 规 格 │ │
├───────┼────────────┴────┴───────────┤
│包装规格 │ │
├───────┼────────────┬────┬───────────┤
│原生产批准文号│ │批准日期│ │
├───────┼────────────┴────┴───────────┤
│批准单位 │ │
├───────┼────────────┬────┬───────────┤
│现批准文号 │ │批准日期│ │
├───────┼────────────┴────┴───────────┤
│批准单位 │ │
├───────┼────────────┬────┬───────────┤
│执行标准 │ │标准文号│ │
├───────┴────────────┴────┴───────────┤
│说明: │
│ │
│(单位公章) │
│ │
├───────┬────────────┬────┬───────────┤
│填表人姓名 │ │填表日期│ │
├───────┴────────────┴────┴───────────┤
│ 省级药品监督管理局对该品种审核意见: │
├─────────────────────────────────────┤
│1.原生产批件 □ 符合要求 □ 不符合要求 │
│2.历年换发批准文号相关文件 □ 符合要求 □ 不符合要求 │
│3.现行质量标准 □ 符合要求 □ 不符合要求 │
│4.药品生产许可证 □ 符合要求 □ 不符合要求 │
│5.药品说明书 □ 符合要求 □ 不符合要求 │
│6.药品包装、标签 □ 符合要求 □ 不符合要求 │
│7.其他相关资料 □ 符合要求 □ 不符合要求 │
├─────────────────────────────────────┤
│审核结论: │
│ │
│ │
│审核人(签字) 日期:_________年____月____日 │
│ │
│注册处负责人(签字) 日期:_________年____月____日 │
│ (公章) │
└─────────────────────────────────────┘
附表二
申报编号:
换发药品批准文号审核意见表
申报单位名称:___________药品监督管理局
申报日期:_________年_____月_______日
国家药品监督管理局制
填 表 说 明
1.申报编号由专项工作小组在接到省级药品监督管理局申报表后按下述编号方法编制填
写:编号首位以省的汉字简称开始,第2位是6位以阿拉伯数字书写的、以“0”补位
的流水号。
2.“审核通过的品种目录”为经省级药品监督管理局审核通过的拟换发药品批准文号的品
种目录。
3.“综合意见”指省级药品监督管理局对审议通过的品种目录中所列品种的整体审核结
论。
换发药品批准文号审核意见表
┌─────────────────────────────────────┐
│ │
│综合意见: │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
├─────────────────────────────────────┤
│ │
│ │
│经办人:(签字) 日期 _______年_____月_____日 │
│ │
│处负责人:(签字) 日期 _______年_____月_____日 │
│ │
│局领导:(签字) 日期 _______年_____月_____日 │
│(单位公章) │
│ │
└─────────────────────────────────────┘
附表: ( )批审核通过的品种目录
┌────┬────┬──┬──┬────┬────┬─────┬─────┐
│申请编号│药品名称│剂型│规格│包装规格│执行标准│ 生产企业 │原批准文号│
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
├────┼────┼──┼──┼────┼────┼─────┼─────┤
│ │ │ │ │ │ │ │ │
└────┴────┴──┴──┴────┴────┴─────┴─────┘
_______省药品监督管理局
(章)
_______年____月___日
TRANSFER OF BUSINESSES (PROTECTION OF CREDITORS) ORDINANCE ——附加英文版
Hong Kong
TRANSFER OF BUSINESSES (PROTECTION OF CREDITORS) ORDINANCE
(CHAPTER 49)
Whole document:
rotect creditors on the transfer of businesses, to provide
for the
ility of transferees of business, the manner in which such
liability
be avoided and for matters incidental thereto and connected
therewith,
to repeal the Fraudulent Transfers of Businesses Ordinance.
June 1980]
1. Short title
Ordinance may be cited as the Transfer of Businesses (Protection
of
itors) Ordinance.
2. Interpretation
In this Ordinance, unless the context otherwise requires--
eal" includes a motion for a new trial or to set aside a
verdict,
ing or judgment;
iness" means a business, or any part thereof, consisting of a
trade or
pation (other than a profession) whether or not it is carried on
with
ew to profit; "charge" means--
a debenture within the meaning of the Companies Ordinance (Cap.
32);
a mortgage;
a bill of sale;
a lien; or
any document,
r or pursuant to which a business or any assets thereof are charged
as
rity for the payment of money or the performance of an obligation,
and
udes an equitable charge;
rge-holder" means a person who, under or pursuant to a charge,
and for
purpose of enforcing payment of any money or for the
performance of
obligation, may sell any business;
e of transfer" means the date on which a transfer takes effect
or is
nded to take effect;
ice of transfer" means a notice of transfer in accordance with
section
registered charge" means a charge which is registered under--
the Land Registration Ordinance (Cap. 128);
the Companies Ordinance (Cap. 32);
the Bills of Sale Ordinance (Cap. 20); or
any other enactment;
nsfer" means the transfer or sale of a business, but does not
include-
the sale of the stock-in-trade of a business in the ordinary
course of
trade;
the creation of a charge;
the transfer of land or any share or interest therein; or
the transfer of a vessel (or the transfer of any interest or
share
ein), other than--
a vessel to which Part IV of the Shipping and Port Control
Ordinance
. 313) applies; or
a trawler to which Part XII of the Merchant Shipping Ordinance
(Cap.
applies; "transferee" means the person to whom a
business is
sferred by a transferor; "transferor" means--
in the case of the sale of a business under or pursuant to a
charge,
person whose business has been or is intended to be sold;
in every other case, the person by whom or on whose
behalf the
sfer has been or is intended to be made.
For the purposes of this Ordinance "transferor" and
"transferee"
ectively include a sub-transferor and a sub-transferee.
3. Transferee of business to be liable for liabilities of trans-
feror
Subject to this Ordinance, whenever any business is transferred,
with
ithout the goodwill thereof, the transferee shall,
notwithstanding any
ement to the contrary, become liable for all the
debts and
gations, including liability for tax charged or chargeable
under the
nd Revenue Ordinance (Cap. 112), arising out of the carrying on
of the
ness by the transferor.
Notwithstanding subsection (1), where a part of a
business is
sferred (other than the goodwill thereof) and in any
proceedings--
the transferee would, but for this subsection, be adjudged
liable
r this Ordinance for any debts and obligations arising out
of the
ying on of the business by the transferor; and
it is shown to the satisfaction of the court hearing the
proceedings
--
the transferee purchased such part of the business in good faith
and
value; and
at the date of transfer of such part of the business, the
transferee
no knowledge (whether actual, constructive or imputed)
what he was acquiring formed part of a business,
transferee shall not be liable under this Ordinance for the debts
and
gations arising out of the carrying on of the business
by the
sferor.
4. Circumstances in which the transferee's liability ceases
A transferee shall not become liable under section 3 if a
notice of
sfer has been given not more than 4 months, and not less than 1
month,
re the date of transfer and has become complete at the
date of
sfer.
Where a notice of transfer has been given but the notice
has not
me complete at the date of transfer, the liability of the
transferee
r section 3 shall cease with effect from the date on which the
notice
ransfer becomes complete.
Where a notice of transfer has not been given before or at the
date of
sfer, the liability of the transferee under section 3 shall cease
with
ct from the date on which a notice of transfer, which is given
after
date of transfer, becomes complete.
A notice of transfer shall, subject to subsections (5) and (6),
become
lete upon the expiration of 1 month after the date of
the last
ication of the notice in accordance with section 5.
Subject to subsection (6), in the case of a notice of
transfer
rred to--
in subsection (1), if proceedings are instituted
against the
sferor in respect of any liability of the transferor arising
before
notice has become complete and out of the carrying on
of his
ness; or
in subsection (2) or (3), if proceedings are instituted
against the
sferee in respect of any liability of the transferee under
section 3
ing before such notice becomes complete,
notice of transfer shall (for the purposes of such proceedings
only)
eemed incomplete pending the final determination of such
proceedings,
uding all possible appeals, and pending the expiration of all
periods
ng which such appeals may be brought.
Where proceedings are instituted, a notice of transfer shall
not be
ed incomplete under subsection (5) unless within 1 month
of the
eedings being instituted--
they are served on the transferor or transferee, as the case may
be;
written notice that they have been instituted is sent by
registered
to the last known address of such transferor or transferee.
5. Contents of notice of transfer and manner of giving notice
Except in the case of a transfer by way of sale under or pursuant
to a
ge, a notice of transfer shall contain the following
particulars--
the full name and address of the transferor;
the nature of the business and the name or style under which, and
the
address at which, it has been carried on during the period
of 6
hs immediately preceding the date of transfer;
the date of transfer;
the full name and the residential and business addresses
of the
sferee;
if the transferee--
intends to carry on or is carrying on the business, the full
address
e, and the name and style under which, he is carrying it on or
intends
arry it on; or
is not carrying on the business and does not intend to carry it
on, a
ement to that effect; and
a statement that at the expiration of 1 month after the date of
the
publication of the notice pursuant to subsection (3), the
liability
he transferee for all the debts and obligations arising out
of the
ying on of the business by the transferor shall cease by
virtue of
Ordinance unless proceedings are instituted prior to such
expiration.
In the case of a transfer by way of sale under or pursuant
to a
ge, a notice of transfer shall contain the following
particulars--
the nature of the business, and the name or style under which,
and the
address at which, it has been carried on during the period
of 3
hs immediately preceding the date of transfer;
the full name and address of the person whose business has been,
or is
nded to be, transferred by way of sale under or pursuant
to the
ge;
details of the charge under or pursuant to which the transfer by
way
ale has been or is to be made, sufficient to enable any
document
ting or evidencing the charge to be readily identified and,
without
ting the generality of the foregoing, such details shall
include--
the date when the charge was made, given, executed or
came into
tence;
the consideration for which the charge was executed, made or
given
if there was no such consideration, the circumstances in which
it came
existence;
) in the case of a registered charge, the date of the registration
of
charge, the title of any enactment under which it was registered
and
number or other means of identifying the charge assigned to it
upon
stration;
the date of transfer; and
the amount of money, payment of which has been secured by the
charge
which was owing--
at the date of the publication of the notice of transfer; or
if the transfer has already taken effect, at the date of the
transfer
aking effect.
Every notice of transfer shall be signed--
by both the transferor and the transferee, in the case of a
transfer
hich subsection (1) applies; or
by the charge-holder and the transferee, in the case of a transfer
to
h subsection (2) applies,
shall be given by publication in--
the Gazette;
any 2 of such Chinese language newspapers circulating in Hong Kong
as
be approved for the purpose by the Chief Secretary; and (Amended
L. N.
f 1985; L. N. 242 of 1989)
) 1 English language newspaper circulating in Hong Kong which has
been
pproved.
6. Right of transferee to indemnity
The transferee shall be entitled to be indemnified--
by the transferor, except in the case of a transfer by way of
sale
r or pursuant to a charge; or
by the charge-holder, if the transfer is by way of sale
under or
uant to a charge,
all amounts for which the transferee is made liable
under this
nance and for which he would not otherwise be liable.
The amount of such an indemnity may be recovered by civil
proceedings
debt or liquidated demand.
7. Liability of parties not affected
ing in this Ordinance shall relieve or be deemed to
relieve a
sferor or transferee, or any person who sells a business
under or
uant to a charge, from any liability to which he would
otherwise be
ect.
8. Limitation of liability of transferee
A transferee who in good faith and without preference has
paid in
harge or partial discharge of any liability for which he became
liable
r this Ordinance, and for which he would not otherwise
have been
le, an amount which is equal to the value of the business acquired
by
at the date on which the transfer took effect, shall not be
liable
her under this Ordinance.
The value of a business acquired by a transferee at the date on
which
transfer takes effect shall, until the contrary is proved, be
presumed
e an amount equal to the amount paid or agreed to be paid (whether
in
s of money or by means of any other consideration) for the
acquisition
he business.
9. Limitation of time for institution of proceedings
ect to section 6, no action shall be instituted to recover any
debt
or to enforce any obligation against any person liable therefor
under
Ordinance, and for which he would not otherwise have been
liable,
than 1 year after the date on which the transfer in respect of
which
liability arose took effect.
10. Saving
Ordinance shall not apply to any transferee where the transfer
ffected--
by the Official Receiver or a trustee in bankruptcy;
by the liquidator of a company in liquidation other than
voluntary
idation;
by the Financial Secretary Incorporated; (Amended L. N. 369 of
1989)
by the Director of Education Incorporated;
by the Director of Social Welfare Incorporated;
by a person selling under or pursuant to a charge which has
been
stered for not less than 1 year at the date when the transfer
takes
ct;
pursuant to any order or direction of any court;
by an executor or administrator; or
by operation of law.
11. Repeal and saving
The Fraudulent Transfers of Businesses Ordinance (Cap. 49, 1964
Ed.)
epealed.
Notwithstanding subsection (1), the Fraudulent Transfers of
Businesses
nance (Cap. 49, 1964 Ed. ) shall continue to apply with respect
to a
sfer--
which took effect; and
in respect of which notice was given under section 3
of that
nance, before the coming into operation of this Ordinance, as if
this
nance had not been passed.