Guidelines for the approval service of packaging m

2022-08-15
  • Detail

Service guide for the approval of packaging materials and containers in direct contact with drugs

Drug Administration Law of the people's Republic of China, regulations for the implementation of the drug administration law of the people's Republic of China, and measures for the administration of packaging materials and containers in direct contact with drugs

IV. acceptance institution

drug evaluation center of the State Food and Drug Administration

v. decision institution

State Food and Drug Administration

VI. approval quantity

unlimited quantity

VII. Working conditions

applicant conditions: the overseas applicant should be a manufacturer of drug packaging materials legally registered abroad

VIII. Application materials

(I) approval of packaging materials and containers imported (including Hong Kong, Macao and Taiwan) in direct contact with drugs

1 Catalogue of application materials

⑴ application form for registration certificate of imported drug packaging materials and containers:

⑵ legal production qualification certificates, notarial documents and their Chinese translations of producers

⑶ the authorization document, notarial document and its Chinese translation entrusted by the manufacturer of the declared product to the agent in China. The industrial and commercial license of the agency in China or the registration certificate of the Permanent Representative Office of foreign enterprises in China of the permanent office of the declared product manufacturer in China

⑷ overview of the production, sales and application of the declared products abroad and the reasons for applying for registration in China

(5) quality inspection reports of three batches of declared products issued by the inspection agency of drug packaging materials set up or determined by the State Food and drug administration

(6) cleanliness inspection report of clean room (area) and self inspection report of three batches of products

⑺ the formula of the declared product

(8) description of the production process and main production and inspection equipment of the declared product

(9) quality standards of declared products

⑼ research data of stability test (drug compatibility test) jointly carried out with drugs packaged with declared products

⑾ plan of declared product production plant and clean room (area)

2. General requirements for application materials:

⑴ the first page of the application materials is the directory of application materials, and the application materials in the directory are listed in the order specified in Annex III of the measures for the administration of packaging materials and containers in direct contact with drugs (Order No. 13 of the State Food and Drug Administration). The cover of each item of information shall be marked with the name of the drug packaging material, the number of the data item, the name of the item, the name of the contact person of the application institution, and the address

⑵ the application materials shall be printed or copied on A4 paper, with clear contents and shall not be altered. The data shall be complete and standardized, and the data shall be true and reliable

⑶ the data shall be put into the archive bag by set, and the cover of the archive bag shall be marked with: application classification, registration classification, name of packaging materials, set X, bag x, each set of X bags, original/copy, contact person, contact person, name of application registration agency

⑷ submit 2 sets of complete application materials (1 set is the original and 1 set is the copy), and 3 copies of application form (2 copies in the original and 1 copy in the copy)

(5) application form for registration of drug packaging materials: download the "procedure for submission of drug registration application form" from the State Food and Drug Administration Station (), fill in it as required, print it and save it

⑥ when mailing or submitting the application materials, the electronic version of the application form should be sent to slzx@

⑺ the data check code of the electronic application form and the paper application form should be consistent

8 all application materials should be in Chinese and attached with English, and other language materials can be attached for reference. The Chinese translation should be consistent with the original text

3. Specific requirements for application materials:

⑴ application form for registration of drug packaging materials: fill in the application form according to the filling instructions, and all applicants should sign and seal the application form (if any)

⑵ supporting documents:

1) legal production qualification certificates, notarial documents and their Chinese translation of the producer

the applicant shall submit copies of the supporting documents (equivalent to China's industrial and commercial business license, production license or registration certificate) that the government department of the country of origin approves it to engage in the production and business of drug packaging materials, the original notarial certificate issued by the notary organ of the country of origin and the Chinese translation. If the government of the country of origin stipulates that the above-mentioned special approval documents are not required, such information may be exempted after truthful explanation

2) the original of the authorization document that the foreign manufacturer entrusts the domestic agent in China to declare, the original of the notarial certificate issued by the notary office in the country where it is located and the Chinese translation

3) the copy of the industrial and commercial business license of the domestic agent in China or the copy of the registration certificate of the Permanent Representative Office of foreign enterprises in China of the permanent office of the foreign manufacturer in China

⑶ the production, sales, and Application Overview and reasons for application for registration in China

⑷ inspection report:

1) the quality inspection report of the three batches of declared products issued by the inspection agency of drug packaging materials set up or determined by the State Food and drug administration shall be the original, which can be submitted separately after the start of the technical review

2) the original clean room (area) cleanliness inspection report within one year of the declaration date shall be submitted

3) the original self inspection report of three batches of declared products shall be submitted

(5) quality standard:

if the quality standard of the drug packaging materials provided is new drug packaging materials or enterprise standards, the standard drafting instructions should also be provided

(6) other materials shall be sorted out in accordance with Annex III of the measures for the administration of packaging materials and containers in direct contact with drugs (Order No. 13 of the State Food and Drug Administration)

(II) re registration of packaging materials and containers imported (including Hong Kong, Macao and Taiwan) in direct contact with drugs

1 Catalogue of application materials

⑴ application form for re registration of drug packaging materials

⑵ the approval certificate of drug packaging materials and the approval change certificate issued by our bureau

⑶ legal production qualification certificates, notarial documents and their Chinese translations of producers

⑷ the authorization document, notarial document and its Chinese translation entrusted by the manufacturer of the declared product to the agent in China. The industrial and commercial license of the agency in China or the registration certificate of the Permanent Representative Office of foreign enterprises in China of the permanent office of the declared product manufacturer in China

(5) quality inspection reports of three batches of declared products issued by the inspection agency of drug packaging materials set up or determined by the State Food and drug administration

(6) cleanliness inspection report of clean room (area) and self inspection report of three batches of products

⑺ the formula of the declared product

(8) description of the production process and main production and inspection equipment of the declared product

(9) quality standards of declared products

(10) a summary report on the sales and quality of the product in China within three years

(11) implementation of the work required to be continued when approving the registration or re registration of the product

2. General requirements for application materials:

⑴ the first page of the application materials is the directory of application materials, and the application materials in the directory are listed in the order specified in Annex IV of the measures for the administration of packaging materials and containers in direct contact with drugs (Order No. 13 of the State Food and Drug Administration). The cover of each item of information shall be marked with the name of the drug packaging material, the number of the data item, the name of the item, the name of the contact person of the application institution, and the address

⑵ the application materials shall be printed or copied on A4 paper, with clear contents and shall not be altered. The data shall be complete and standardized, and the data shall be true and reliable

⑶ the data shall be put into the archive bag by set, and the cover of the archive bag shall be marked with: application classification, registration classification, name of packaging materials, set X, bag x, each set of X bags, contact person of the original/copy, contact person, name of the application registration agency

⑷ submit 2 sets of complete application materials (1 set is the original and 1 set is the copy), and 3 copies of application form (2 copies in the original and 1 copy in the copy)

(5) drug packaging material re registration application form: download the "drug registration application form submission procedure" from the State Food and Drug Administration Station (), fill in it as required, print it and save it

⑥ when mailing or submitting the application materials, the electronic version of the application form should be sent to slzx@

⑺ the data check code of the electronic application form and the paper application form should be consistent

8 all application materials should be in Chinese and attached with English, and other language materials can be attached for reference. The Chinese translation should be consistent with the original text

3. Specific requirements for application materials:

⑴ application form for re registration of drug packaging materials: fill in the application form according to the filling instructions, and all applicants should sign and seal the application form (if any)

⑵ supporting documents:

1) copies of drug packaging materials approval documents and approval change certificates issued by our bureau

2) producers' legal production qualification certificates, notarial documents and their Chinese translations

the applicant should submit copies of supporting documents (equivalent to China's industrial and commercial business license, production license or registration certificate) that the government department of the country of origin approves it to engage in the production and business of drug packaging materials The original and Chinese translation of the notarial certificate issued by the notary office of the country where it is located. If the government of the country of origin stipulates that the above-mentioned special approval documents are not required, such information may be exempted after truthful explanation

3) the original of the authorization document that the foreign manufacturer entrusts the agent in China to declare The original and Chinese translation of the notarial certificate issued by the notary office of the country where it is located

4) a copy of the industrial and commercial business license of the agency in China or the registration certificate of the Permanent Representative Office of foreign enterprises in China of the permanent office of the foreign manufacturer in China Copy

⑶ inspection report:

1) the quality inspection report of the three batches of declared products issued by the inspection agency of drug packaging materials set up or determined by the State Food and drug administration shall be the original, which can be submitted separately after the technical review begins

2) the original cleanliness inspection report of the clean room (area) pressing the power button within one year of the declaration date shall be submitted

3) the original self inspection report of three batches of declared products shall be submitted

⑷ change:

1) if there is a change from the last registration, the specific change should be pointed out and indicated on the application form

2) if the quality standard changes, the original quality standard, the revised quality standard and the revision instructions shall be provided

3) if the foreign manufacturer changes, it should be noted on the application form

4) if the agency changes, the authorization document, notarial document and its Chinese translation of the new Chinese agency authorized by the manufacturer of imported drug packaging materials shall be provided. A copy of the business license of the new Chinese agency and the supporting documents of the original agency agreeing to abandon the agency

(5) summary report:

should include the annual sales volume in China, the drug manufacturers using this product and the catalogue of packaged drugs, users' use evaluation, quality inspection, self inspection qualification rate of this product by the drug packaging material manufacturers, quality accidents and government quality sampling inspection

(6) other materials shall be sorted out in accordance with Annex 4 of the measures for the administration of packaging materials and containers in direct contact with drugs (Order No. 13 of the State Food and Drug Administration)

(III) review of supplementary application for packaging materials and containers of imported (including Hong Kong, Macao and Taiwan) drugs in direct contact

1 Catalogue of application materials

⑴ supplementary application form for drug packaging materials

⑵ drug packaging material batch

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