加拿大外贸
粉状物，有走过巴基斯坦并且处理过Form 3 和 Form 7的同志私聊我下，谢谢评论
自己顶一下，没有人吗？
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没人那就自力更生了。
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客户给的，见附件！！
[ 本帖最后由 qtyq123 于 2017-1-5 10:59 编辑 ]
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DRUGS (IMPORT & EXPORT) RULES, 1976
S R O. 890 (I)/76. In exercise of the powers conferred by Section 43 of the Drugs Act, 1976 (XXX! of 1976), the Federal Government is pleased to make the following rules, the same having been previously published as required by sub-section (3) of the said. section) namely :--
CHAPTER I
1. Short title and commencement. (1) These rules may be called the Drugs (import and Export) Rules, 1976.
(2) They shall come into force at once.
2. Definitions. In these rules unless there is anything repugnant in the subject or context :-
(a) "Act" means the Drugs Act, 1976 ('XXXI of 1976); and
(b) "form" means form appended to these rules.
CHAPTER 11
IMPORT OF DRUGS
3. Import of finished drugs. Finished drugs may be imported subject to the following conditions, namely :-
(i) the importer possesses a licence to sell by way of retail wholesale, the drug intended to be imported and has adequate facilities for proper storage to preserve its properties
(ii) the importer shall, within fifteen days of establishing the letter of credit, intimate such action on Form I to an officer authorised by the Federal Government in this behalf;
(iii) the drug shall be imported in containers intended for retail sale or supply to hospitals, dispensaries or such other institutions; and
(iv) the drugs shall be imported against indents issued by the authorised indentors or local agents of the manufacturers.]
Provided that such drug may be imported in bulk containers by any person who possesses a licence for re-packing and has obtained permission in writing to such import from an officer authorised by the Federal Government in this behalf.
4. Types of licences to import drugs. Licences to import drugs shall be of the following types, namely :--
(i) licence to import drug other than the finished drugs; and
(ii) licence to Import small quantities of drugs for the purpose of clinical trial, examination, test or analysis.
5. Licences for import of drugs manufactured by one manufacturer. A single application shall be made, and a single licence shall be required, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer:
Provided that if a manufacturer front whom the drugs are to be imported has two or more premises manufacturing the same or different drugs. a separate application shall be made,. and a separate licence shall be required, in respect of the. drugs manufactured in each such premises.
6. Application for licence to import drugs. (1) An application for licence to import drugs other than finished drugs shall be made to the licensing authority in Form 2 and shall be accompanied by a fee of fifty rupees and by an undertaking in Form 3, signed by or on behalf of the manufacturer:
Provided that in the case of a subsequent application by the same importer for addition to the import licence of any drug manufactured by the same manufacturer, the fee to accompany each such application shall be twenty-five rupees.
(2) A fee of twenty. five rupees shall be paid for a duplicate copy of licence issued under this Chapter if the original is defaced, damaged or lost.
(3) An application for a licence to import small quantity of drugs for the purpose of clinical trial, examination, test or analysis shall be made to the licensing authority in Form 4; and the licensing authority may require such other particulars to be supplied as it may consider necessary.
(4) Any fee deposited under sub rule (1) or sub rule (2) shall in no case be refunded.
7. Licence to import drugs. A licence to import drugs other than finished drugs shall be issued in Form 5 and for the import of small quantity of drugs for clinical trial, examination, test or analysis shall be issued in Form 6.
8. Duration of licence to import drugs. Licence to import drugs, unless earlier suspended or cancelled, shall be valid for two years.
9. Licensing authority. For the purpose of this Chapter, "licensing authority" means the authority appointed by the Federal Government to issue licences to import drugs and includes any person subordinate to it to whom such authority may, with the approval of the Federal Government by an order in writing, delegate the power to sign licences and such other powers as may be specified in the order.
10. Grant of licence to import drugs. On receipt of an application fern licence to import drugs the licensing authority shall. on being satisfied that, if granted, she conditions of the licence will be observed issue an import licence.
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11. Conditions of licence to import drugs other than finished drugs: A licence to import drugs other than finished drugs shall bc subject to the following conditions, namely :--
(i) the manufacturer shall at all times observe the under-taking given by him or on his behalf in Form 3;
(ii) the license shall allow the licensing authority or any person authorised by it in this behalf to enter, with or without prior notice. any premises where the imported drug is stocked to inspect the means, if any, employed for testing the drug and to take samples;
(iii) the licensee shall on request furnish to the licensing authority from every batch of each drug or from such batch or batches as the licensing authority may from time to time specify as sample in such quantity as the licensing authority may consider adequate for any examination, test or analysis required to be made, and the license shall, if so required furnish full protocols of the tests, if any which have been applied;
(iv) the licensee shall ensure proper storage facilities for preserving the properties of the imported drug;
(v) the licensee shall maintain a complete record of utilization of the imported drug, showing particulars of the substance manufactured from it and such further particulars, if any as the licensing authority may specify and such record shall be open to the inspection of licensing authority or any person authorised in this behalf by the licensing authority
(vi) the licensee shall comply with such further requirements, if any applicable to the holders of import licences, as may be specified in any rules subsequently made under the Act in this behalf and of which the licensing authority has given to him not less than three months notice.
12. Conditions of licence to import small quantities of drugs for clinical trial, etc : A licence to import small quantities of drugs including drugs the import of which is otherwise prohibited under the Act for the purposes of clinical trial, examination, test or analysis shall be subject to the following conditions, namely:-
(a) the licensee shall exclusively use the drug for the purpose for which it has been imported and at the place specified in the licence, or at such other plate as the licensing authority may from time to time authorise;
(b) the licensee shall allow the licensing authority or any person authorised by it in this behalf to enter, with or without prior notice, the premises where the drugs are kept and to inspect the premises and investigate the manner in which the drugs are being used and to take samples thereof;
(c) the licensee shall keep record of, and shall report to the. licensing authority, the drugs imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer;
(d) the licensee shall comply with such further requirements if any, applicable to the holders of licences for clinical trial, examination, test or analysis as may be specified in any rules subsequently made under the Act and of which the licensing authority has given to him not less than .one month's notice.
13. Import of drugs for personal use: Small quantities. of drugs including drugs the import. of which is otherwise prohibited tinder the Act may be imported for personal use subject to the following conditions. namely :--
(a) the drugs shall form part or a passenger's bona fide baggage and shall be intended for the exclusive .personal use. of the passenger;
(b) the quantity of any single drug so imported shall not exceed one hundred average doses:
Provided that any drug imported for personal use but not forming part of bona fide personal baggage may be allowed to be imported subject to the following conditions, namely :-
(i) the licensing authority on an application being made to it prior to the import, and. being satisfied that the drug is for bona tide personal use has granted permission for the import of the said drug; and
(ii) the quantity to be imported is, in the opinion of the licensing authority, reasonable and is covered by a prescription from a registered medical practitioner.
14. General provisions regarding import: An importer of drugs. except where such import is for personal use, shall comply with the following general provisions, namely :--
(a) the importer shall allow any person authorised in. this behalf to enter, with or without prior notice, any premises where the imported drugs are stocked, to inspect the storage facilities and to take samples for testing ;
(b) the importer shall, on being informed by the Registration Board or the licensing authority or an officer authorised by it in this behalf or the Chairman .of the Provincial Quality Control Board that any part of any batches of a drug has been found to be in contravention of the provisions. of the Act or the rules made thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as practicable, recall the issues already made from that batch and dispose of in such manner as the Board or, as the case may be, the authority, may direct;
(c) the importer shall maintain a record of all sales by way of wholesale made by him of the imported drugs, and such record shall be open to the inspection by any person authorised in this behalf;
(d) the importer shall ensure that the import of each batch of a drug is accompanied by--
(i) a batch certificate in Form 7 from the competent health authority or any other such agency of the country of export or from the manufacturer;
(ii) a copy of the test report of the drug from the competent health authority or any other such agency of the country of export or from the manufacturer;
(e) the importer shall maintain an inspection book on which a member of the Registration Board or of the licensing authority or an Inspector shall record proceedings of each of his visits, his impressions and the defects notified by him and such inspection book shall be signed by him as well as the. licensee or his authorised agent;
(f) the importer, shall on receipt of information of arrival of the consignment of drugs at the port of importation report in Form 8 alongwith three copies of the invoice to the officer authorised by the Federal Government to grant clearance under rule 15.
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15. Procedure at customs-ports: (1) No drug shall be released from the customs unless a clearance certificates has been obtained by the importer from an officer authorised in this behalf by the Federal Government.
(2) If the Collector of Customs or an officer authorised by him has reason to suspect that any drug does not comply with the provisions of the Actor the rules made thereunder, he may, or if requested by as officer authorised in this behalf by the Federal Government shall, take samples of any drugs from the consignment and forward them to the officer-in charge of the laboratory appointed for the purpose by the Federal Government and may detain the drugs from the consignment of which samples have been taken until the report of the officer-in charge of the said laboratory on such samples is received:
Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Collector of Customs and to return the consignment or such portion thereof as may be required, the Collector of Customs shall make over the consignment to the importer.
(3) If an importer who has given an undertaking under the proviso to sub-rule (2} is required by the Collector of Customs to return the consignment or any portion thereof. he shall return the consignment or portion thereof within ten days of receipt of the notice.
(4) If the officer-in-charge of the laboratory appointed for the-purpose by the Federal Government reports to the Collector of Customs that the samples of any drug in a consignment do not conform to the specification or that the drug contravenes in any other respect the provisions of the Act or the rules made thereunder and that the contravention is such it cannot be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer who shall within two months of his receiving the communication, either export all the drugs of that description in the consignment to the country from which they were imported or surrender them to the Federal Government for disposal in such manner as it may deem fit:
Provided that the importer may, within fifteen days of the receipt of the report make a representation against the report to the Collector of Customs who shall forward the representation with a further sample to the licensing authority or, as the case may be, the Registration Board which after obtaining, ff necessary, the report of the .officer-in-charge of the Federal Drugs Laboratory, shall pass orders thereon which shall be final.
(5) If he officer-in- charge of the laboratory appointed for the purpose by the Federal Government reports to the Collector of Customs that the samples of any drug contravene in any respect the provisions of the Act or the rules made thereunder and that the contravention is such that it can be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of that drug without remedying the said contravention.
(6) A Federal a provincial Inspector Inspector or a person authorised in this behalf by the Federal Government may physically inspect the consignment and draw samples from each batch for test and analysis as may be necessary and, if the consignment has been released by the customs, may order the importer not to sell or offer for sale or dispose of the drug for a reasonable period not exceeding one month with a view to obtain a test report:
Provided that the Federal a provincial Inspector Inspector or such authorised officer may prohibit the disposal of a drug for a longer. period if he has sufficient reason to believe that the import, in any way, is in contravention of any or the provision of the Act or these rules in which case. the importer shall not dispose of that drug until a certificate authorising the sale of the batch has been issued to him.
16. Suspension and cancellation of licence to import drugs: If the manufacturer or licensee fails to comply with any of the conditions of a licence to import drugs or violates any of the provisions of the Act or the rules made thereunder, the licensing authority may, after giving the licensee an opporntunity of being heard, by an order in writing stating the reason therefor, suspend or cancel the licence for such period as it thinks tit or cancel for all times. either wholly or in respect of some of the drugs. to which it relates or, if the nature of offence is so serious that it is likely to endanger the public health, .may prohibit the import of all other drugs of the said manufacturer:
Provided that a person who is aggrieved by the suspension or cancellation of his licence, may. within sixty days of the receipt of such order, appeal to the Appellate Board.
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根据1976药法要求，共有12个相应表格，模板如下
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加拿大电商昨天我把提单复件发给了客户，今天收到了他回信，如下： Dear Nicholas, please send all shipping documents. We will check B/L copy and we will reply ASAP. Thank you Best Regards ......................................... 加拿大电商刚从事这行半年，对电子行业不了解，自己整理了些，算是学习，供大家分享，也请大家补充。我毕竟是个文科生，对这方面知识严重欠缺。 DVD:英文全名是Digital Video Disk, 即数字视频光
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