对外贸易经营者备案登记办法
商务部
对外贸易经营者备案登记办法
商务部令
(2004年第14号)
《对外贸易经营者备案登记办法》已于2004年6月19日经商务部第九次部务会议讨论通过,现予发布,自2004年7月1日起施行。
部长:薄熙来
二00四年六月二十五日
对外贸易经营者备案登记办法
第一条 为促进对外贸易发展,根据《中华人民共和国对外贸易法》(以下简称《外贸法》)第九条的有关规定,制订本办法。
第二条 从事货物进出口或者技术进出口的对外贸易经营者,应当向中华人民共和国商务部(以下简称商务部)或商务部委托的机构办理备案登记;但是,法律、行政法规和商务部规定不需要备案登记的除外。
对外贸易经营者未按照本办法办理备案登记的,海关不予办理进出口的报关验放手续。
第三条 商务部是全国对外贸易经营者备案登记工作的主管部门。
第四条 对外贸易经营者备案登记工作实行全国联网和属地化管理。
商务部委托符合条件的地方对外贸易主管部门(以下简称备案登记机关)负责办理本地区对外贸易经营者备案登记手续;受委托的备案登记机关不得自行委托其他机构进行备案登记。
备案登记机关必须具备办理备案登记所必需的固定的办公场所,管理、录入、技术支持、维护的专职人员以及连接商务部对外贸易经营者备案登记网络系统(以下简称“备案登记网络”)的相关设备等条件。
对于符合上述条件的备案登记机关,商务部可出具书面委托函,发放由商务部统一监制的备案登记印章,并对外公布。备案登记机关凭商务部的书面委托函和备案登记印章,通过商务部备案登记网络办理备案登记手续。对于情况发生变化、不符合上述条件的以及未按本办法第六、七条规定办理备案登记的备案登记机关,商务部可收回对其委托。
第五条 对外贸易经营者备案登记的程序
对外贸易经营者在本地区备案登记机关办理备案登记。
对外贸易经营者备案登记程序如下:
(一)领取《对外贸易经营者备案登记表》(以下简称《登记表》)。对外贸易经营者可以通过商务部政府网站(http://www.mofcom.gov.cn)下载,或到所在地备案登记机关领取《登记表》(样式附后)。
(二)填写《登记表》。对外贸易经营者应按《登记表》要求认真填写所有事项的信息,并确保所填写内容是完整的、准确的和真实的;同时认真阅读《登记表》背面的条款,并由企业法定代表人或个体工商负责人签字、盖章。
(三)向备案登记机关提交如下备案登记材料:
1、按本条第二款要求填写的《登记表》;
2、营业执照复印件;
3、组织机构代码证书复印件;
4、对外贸易经营者为外商投资企业的,还应提交外商投资企业批准证书复印件;
5、依法办理工商登记的个体工商户(独资经营者),须提交合法公证机构出具的财产公证证明;依法办理工商登记的外国(地区)企业,须提交经合法公证机构出具的资金信用证明文件。
第六条 备案登记机关应自收到对外贸易经营者提交的上述材料之日起5日内办理备案登记手续,在《登记表》上加盖备案登记印章。
第七条 备案登记机关在完成备案登记手续的同时,应当完整准确地记录和保存对外贸易经营者的备案登记信息和登记材料,依法建立备案登记档案。
第八条 对外贸易经营者应凭加盖备案登记印章的《登记表》在30日内到当地海关、检验检疫、外汇、税务等部门办理开展对外贸易业务所需的有关手续。逾期未办理的,《登记表》自动失效。
第九条 《登记表》上的任何登记事项发生变更时,对外贸易经营者应比照本办法第五条和第八条的有关规定,在30日内办理《登记表》的变更手续,逾期未办理变更手续的,其《登记表》自动失效。
备案登记机关收到对外贸易经营者提交的书面材料后,应当即时予以办理变更手续。
第十条 对外贸易经营者已在工商部门办理注销手续或被吊销营业执照的,自营业执照注销或被吊销之日起,《登记表》自动失效。
根据《外贸法》的相关规定,商务部决定禁止有关对外贸易经营者在一年以上三年以下的期限内从事有关货物或者技术的进出口经营活动的,备案登记机关应当撤销其《登记表》;处罚期满后,对外贸易经营者可依据本办法重新办理备案登记。
第十一条 备案登记机关应当在对外贸易经营者撤销备案登记后将有关情况及时通报海关、检验检疫、外汇、税务等部门。
第十二条 对外贸易经营者不得伪造、变造、涂改、出租、出借、转让和出卖《登记表》。
第十三条 备案登记机关在办理备案登记或变更备案登记时,不得变相收取费用。
第十四条 本办法实施前,已经依法取得货物和技术进出口经营资格、且仅在原核准经营范围内从事进出口经营活动的对外贸易经营者,不再需要办理备案登记手续;对外贸易经营者如超出原核准经营范围从事进出口经营活动,仍需按照本办法办理备案登记。
第十五条 本办法由商务部负责解释。
第十六条 本办法自2004年7月1日起实施。凡与本办法不一致的规定,自本办法发布之日起废止。
附件:对外贸易经营者备案登记表(略)
Provisions for Drug Insert Sheets and Labels
Commissioner of SFDA
Provisions for Drug Insert Sheets and Labels
(SFDA Decree No.24)
The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006.
Shao Mingli
Commissioner of SFDA
March 15, 2006
Provisions for Drug Insert Sheets and Labels
Chapter I General Provisions
Article 1 The Provisions are enacted with a view to regulating drug insert sheets and labels in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.
Article 2 The insert sheets and labels of drugs marketed within the territory of the People’s Republic of China shall meet the requirements of the Provisions.
Article 3 Drug insert sheets and labels shall be reviewed and approved by the State Food and Drug Administration.
A drug shall be labeled on the basis of its insert sheet. The content of the label shall be within the scope of the insert sheet. Any words and marks with implied therapeutic effects, misleading information on usage, or inappropriate promotion of the product shall not be printed.
Article 4 A drug label shall be printed on or affixed to the drug package, and no other written words, audio and/or visual materials or other information are attached to introduce or publicize the product or the enterprise.
An insert sheet shall be attached to the smallest package provided by the drug manufacturer for marketing.
Article 5 The wording in drug insert sheets and labels shall be scientific, standardized and accurate. The insert sheet of a non-prescription drug shall be written intelligibly and convenient for patients to judge, choose and use the drug on their own.
Article 6 In the label or insert sheet, the letters or characters shall be clear and easy to be recognized and the marks shall be clear and distinctive. The label and insert sheet shall have no print faded and shall not be affixed unsteadily. Any addition or modification shall not be made by means of pasting, cutting or altering.
Article 7 Drug insert sheets and labels shall be written in standardized Chinese characters published by the National Language Commission. The versions in other languages shall comply with the Chinese version.
Article 8 With the aim to protect public health and direct the rational use of drugs, drug manufacturers may voluntarily apply to add warnings to drug insert sheets or labels. The State Food and Drug Administration may also request drug manufacturers to add warnings to drug insert sheets or labels.
Chapter II Drug Insert Sheet
Article 9 A drug insert sheet shall include the significant scientific data, conclusions and information concerning drug safety and efficacy in order to direct the safe and rational use of drugs. The specific format, content and writing requirements of drug insert sheet shall be prescribed and issued by the State Food and Drug Administration.
Article 10 Disease names, pharmaceutical terms, drug names, the names and results of clinical testing in drug insert sheets shall be expressed in professional terms published or standardized by the State. The units of measurement shall conform to the national standards.
Article 11 All the active ingredients or medicinal ingredients of traditional Chinese medicines in a prescription shall be listed in the insert sheet. For injections and non-prescription drugs, all excipients shall be listed as well.
The ingredients or excipients included in a prescription, which may cause severe adverse reaction, shall be specified.
Article 12 A drug manufacturer shall trace the safety and efficacy of its marketed drugs. For any modification to the insert sheet, an application shall be submitted timely.
The State Food and Drug Administration may also require a drug manufacturer to make modification to the insert sheet on the basis of the results of adverse drug reaction monitoring and drug re-evaluation.
Article 13 After the modification to the insert sheet is approved, the drug manufacturer shall inform relevant drug distributors, drug users and other departments of the modified content immediately, and use the modified insert sheet and label timely as required.
Article 14 The insert sheet shall provide full information on adverse drug reaction and indicate the adverse reactions in detail. A drug manufacturer, who fails to timely modify the insert sheet on the basis of the safety and efficacy data of the marketed drug or to fully explain the adverse reaction in the insert sheet, shall be liable for all the consequences arising therefrom.
Article 15 The approval date and the modification date shall be distinctively shown in the insert sheet.
Chapter III Drug Labels
Article 16 Drug labels refer to the information printed or pasted on drug packaging, including inner labels and outer labels. Inner labels refer to those that appear on immediate packaging; outer labels are those on the other packaging outside of inner labels.
Article 17 The inner label shall bear such drug information as the adopted name in China, indications or functions, strength, dose and usage, production date, batch number, expiry date and manufacturer. If there is no enough space in the package to include all the information mentioned above, the adopted name in China, strength, batch number and expiry date shall be indicated at least.
Article 18 The outer label of a drug shall indicate such information as the adopted name in China, ingredients, description, indications or functions, strength, dose and usage, adverse reactions, contraindications, precautions, storage, production date, batch number, expiry date, approval number and manufacturer. Where indications or functions, dose and usage, adverse reactions, contraindications and precautions cannot be fully noted, main information plus a “See drug insert sheet for details.” notice shall be indicated.
Article 19 The label on the package for transportation and storage shall bear at least the adopted name in China, strength, storage, production date, batch number, expiry date, approval number and manufacturer. Other information such as packaging quantity, precautions for transportation or other marks may be included when necessary.
Article 20 The label for drug substance shall include the adopted name in China, storage, production date, batch number, expiry date, applied specifications, approval number and manufacturer. Other necessary information such as packaging quantity and precautions for transportation shall also be indicated.
Article 21 Where one drug produced by a manufacturer has the same drug strength and packaging specification, the content, format and color of its labels must be the same. Where one drug produced by a manufacturer has different drug strengths or packaging specifications, its labels shall be clearly distinguished from one another, or its specifications shall be notably marked in the corresponding specification items.
Where a drug produced by a manufacturer is administrated as prescription drug and non-prescription drug respectively, their packaging colors shall be distinctly different.
Article 22 For drugs with special requirements on storage, its requirements shall be marked in the notable place of the label.
Article 23 The expiry date in the drug label shall appear in the order of year, month and day, with year shown in four digits, month and day in two digits. Its specific format shall be “Valid till XXXX year XX month” or “Valid till XXXX year XX month XX day”. It may be presented with numbers and other symbols as “Valid till XXXX.XX.” or “Valid till XXXX/XX/XX”.
For the preventive biological product, the expiry date shall be labeled according to the registration specifications approved by the State Food and Drug Administration. The expiry date of the biological product for therapeutic use shall be counted from the filling date. For other drugs, the expiry date shall be counted from the production date.
Where the expiry date is labeled to the day, it shall be marked as one day earlier than the actual expiry date; where the expiry date is labeled to the month, it shall be marked as one month earlier than the actual expiry month.
Chapter IV Use of Drug Name and Registered Trademark
Article 24 The drug name in insert sheets and labels shall conform to the nomenclature principles on the adopted name in China and trade name of drug announced by the State Food and Drug Administration, and shall be consistent with those appeared in the approval documents of the drug.
Article 25 The adopted name in China shall be conspicuous and prominent, and its typeface, size and color shall be consistent, and meet the following requirements:
(1) For horizontal labels, the adopted name in China shall appear in a prominent position within the area of the upper one-third of the label; for vertical labels, it shall appear in a prominent position within the area of the right one-third of the label;
(2) No such illegible typefaces as cursive characters and seal characters shall be used, and no such format as italics, margining and shading shall be used to modify the typefaces.
(3) The font color of the adopted name in China shall be black or white, in sharp contrast to the light-colored or dark-colored background respectively.
(4) Writing in separate lines shall be avoided unless limited by the packaging size.
Article 26 The trade name of a drug shall not be placed in the same line with the adopted name in China; its typeface and color shall be no more conspicuous than that of the adopted name in China, and its font area per character shall be no bigger than half of that of the adopted name in China.
Article 27 Unregistered trademarks and other drug names unapproved by the State Food and Drug Administration shall not be used in the drug insert sheets and labels.
Where a registered trademark is used in a drug label, it shall be printed in a corner of the label. Where a registered trademark contains characters, the font area per character shall be no bigger than a quarter of that of the adopted name in China.
Chapter V Other Provisions
Article 28 For narcotic drugs, psychotropic substances, medicinal toxic drugs, radioactive pharmaceuticals, drugs for topical use, non-prescription drugs and other drugs having special marks specified by the State, their special marks shall be printed in the drug insert sheets and labels.
Where there are special provisions issued by the State for drug insert sheets and labels, they shall prevail.
Article 29 The labeling provisions for Chinese crude drugs and prepared slices of Chinese crude drugs shall be formulated separately by the State Food and Drug Administration.
Article 30 Where drug insert sheets and labels are not in compliance with the Provisions, a punishment shall be imposed in accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China.
Chapter VI Supplementary Provisions
Article 31 These Provisions shall come into force as of June 1, 2006. the Provisions for Drug Packaging, Labels and Insert Sheets (Provisional) issued by State Food and Drug Administration on October 15, 2005 shall be annulled therefrom.