The name of the license is the registration certificate of packaging materials issued by the US Food and Drug Administration.
2、
(Domestic) Approval of packaging materials and containers for the production of drugs in direct contact?
February 20, 2006? Release?
1. Project name: Approval of packaging materials and containers in direct contact with drugs?
Two. License content: (domestic) production license for packaging materials and containers that directly contact drugs.
Pharmaceutical packaging products subject to registration management include:
1, infusion bottle (bag, membrane, accessories); ?
2. Ampoules; ?
3, medicinal (injection, oral or external dosage form) bottle (tube, lid); ?
4. Medicinal rubber stopper; ?
5, medical prefilled syringe; ?
6, medicinal eye drops (nose, ear) bottle (tube); ?
7. Medicinal hard tablets (tablets); ?
8. Medicinal aluminum foil; ?
9, medicinal ointment tube (box); ?
10, medical aerosol pump (valve, tank, cylinder); ?
1 1, medicinal desiccant. ?
Three, the legal basis for the establishment and implementation of the license:
Article 52 of the Drug Administration Law of People's Republic of China (PRC), Article 44 of the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC), and Measures for the Administration of Packaging Materials and Containers in Direct Contact with Drugs.
4. Charge: No charge.
Verb (abbreviation of verb) quantity limit: There is no quantity limit in this license.
List of materials submitted by the intransitive verb applicant:
Application form for registration of pharmaceutical packaging materials
Data number (4) application for business license;
Data number (5) A summary of the production, sales and application of the declared products;
Data number (6) the formula of the declared product;
Data number (7) Description of the production process and main production and inspection equipment of the declared product;
Data number (8) quality standard of declared products;
DataNo. (9) Self-inspection reports of production enterprises of three batches of declared products;
DataNo. (10) Research data of the stability test (drug compatibility test) carried out simultaneously with the drugs in the declared product package;
The data number (1 1) declares the plan of the product production workshop and clean room (area);
The data number (12) declares that the product manufacturer's environmental protection, waste gas and wastewater discharge, safety and fire protection comply with relevant national laws and regulations.
For the specific requirements of the above application materials, see Annex II of the Measures for the Administration of Packaging Materials and Containers in Direct Contact with Drugs.
Seven. Requirements for application materials:
(1) General requirements of application materials:
1. The application materials shall be numbered according to the data sequence specified in Annex II of the Measures for the Administration of Packaging Materials and Containers in Direct Contact with Drugs (OrderNo. US Food and Drug Administration 13) and bound separately according to the numbers. The first page of the application materials is the catalogue of application materials.
2. The application materials shall be printed on A4 paper, with complete and clear contents and shall not be altered.
3. The data cover shall contain the following information: the name of the packaging material, the data item number, the project name, the name, telephone number and address of the contact person of the applicant, the name of the unit that completed the test data, the main finisher, the participants, the telephone number and the storage place of the original data. And must be stamped with the official seal of each institution.
4. The materials should be put into an file bag, and the cover of the file bag should indicate: application classification, registration classification, drug name, X bags of the bag, each set of X bags, original/copy, applicant, contact person and telephone number.
5. To apply for registration, two complete sets of application materials (at least 1 set is the original) and 1 set of summary materials (copies are acceptable) are required, and each bag contains 1 application form.
6. Application form for registration of pharmaceutical packaging materials: downloaded from the website of the State Food and Drug Administration (www.sfda.gov.cn), filled in as required, printed and saved. The data check codes of the electronic documents used for submission and the written application form must be consistent and submitted together.
(two) the specific requirements of the application materials:
1. Application Form for Registration of Packaging Materials
(1) The Application Form for Registration of Pharmaceutical Packaging Materials is one of the important documents for acceptance and review. All items must be filled in, and no omissions are allowed. If there is nothing to fill in, fill in "None".
(2) The product name item shall be consistent with the name in the declared variety quality standard. Need to pay attention to the following points:
(1) Products without national standards shall be named according to the naming principle of published national standards for packaging materials.
② For composite film (bag) products, if the applicant does not have the production conditions for making "bags", fill in "XXX composite film" in the product name. If the applicant has the production conditions for making bags and applies for the registration of both films and bags, the product name item should be "XXX composite film and bags".
The product of butyl rubber stopper should indicate its specific halogenation type in the name, such as "chlorinated butyl rubber stopper for injection" instead of "halogenated butyl rubber stopper for injection".
(3) English name: the import application needs to be filled in, and the production application does not need to be filled in.
(4) The dimensions of the declared varieties shall be filled in for the specification items. It should be pointed out that:
The specifications of different composite materials of products such as composite film for drug packaging and multilayer film (bag) for infusion shall be indicated. For example, composite membrane products are divided into PET/PE and PET/AL/PE, and different specifications should be declared separately.
(5) Name of attachment:
(1) If the infusion bottle and infusion bag products simultaneously declare the combination cover, interface, rubber stopper and other accessories, the name of the registered accessories should be filled in here. If you have not declared such accessories, please fill in "None" here and leave it blank.
② The name of each component should be filled in here for pre-installed syringe products.
(3) The rest varieties don't need to fill in this item.
(6) Formula item:
(1) Names of raw materials and additives (colorants, preservatives, plasticizers, opacifiers and inks, etc.). ) The declared product shall be clearly stated, and the formula shall be consistent with the declared data, and the dosage is not required.
(2) For products with declared auxiliary materials, the formula of each auxiliary material shall be separately stated according to the above requirements (1).
(7) The name and number of the quality standard shall be filled in for the quality standard project. If you declare the attachments listed in the above five items at the same time, you should also fill in the quality standards of the attachments.
(8) The applicant's project:
The name of the production enterprise shall be filled in with the name of the legal person organization, which shall be consistent with the attached certification documents.
The registered address items shall be consistent with the registered address in the Business License of Enterprise as a Legal Person.
The production address item refers to the actual production address of the declared product.
If the production unit is a branch without legal person qualification, it can be handled in the following ways: fill in the registered address of the legal person institution and fill in the name and address of the actual production unit (branch without legal person qualification) for the production address. Corporate institutions and branches are stamped with official seals and legal person signatures respectively. In addition, the supporting documents shall provide the business license of the enterprise as a legal person, the original special authorization and guarantee issued by the legal person (see annex 1) and the proof of the relationship between the branch and the legal person.
Telephone and fax items should fill in the telephone number where the contact person can be found directly, and fill in the area code.
(9) The items of "name, official seal, signature and date of the legal representative of each applicant" and "name, official seal, signature and date of the registration institution of import declaration varieties":
The applicant's name, official seal, legal representative's signature, date and other items shall be filled in completely. If the legal representative cannot sign, the person in charge authorized by the legal representative can sign and provide the original power of attorney.
(10) The application form shall be reviewed by the manager of the provincial bureau to ensure the signature, date and completeness of the manager.
2. Application materials
(1) Declare the formula information of products.
① Chemical names, quality standards, sources, functions in the formula, dosage and dosage ratio (by weight) of raw materials and additives (colorants, preservatives, plasticizers, opacifiers, inks, etc.). ) should be clearly stated. For additives, the basis of safe dosage range should also be provided.
(2) Among them, for products such as membrane materials for infusion bags and composite membranes (hard tablets and ointment tubes) for drug packaging, the formula should indicate that the products are composed of several layers of materials and the names of each layer of materials.
③ The membrane used for infusion bags must also clearly state the chemical names, quality standards, sources, functions, dosage and dosage ratio (by weight) of raw materials and additives in each layer.
(4) If you purchase a single-layer membrane for producing composite membrane products, you only need to provide the source and quality standard of the purchased membrane materials.
⑤ If different composite materials for infusion bags and composite films for drug packaging (hard tablets, aluminum foils and ointment tubes) are declared at the same time, it should be regarded as different varieties to provide formula information respectively.
⑥ The caps and bodies of medical plastic bottles shall be formulated separately according to the above provisions.
⑦ For the varieties of infusion bottles and infusion bags, regardless of whether the combined cover, interface and rubber stopper are declared at the same time, the source and quality standard of the combined cover, interface and rubber stopper shall be provided. If the combination cover, interface, rubber plug and other accessories are declared at the same time, the formula of each accessory should be listed separately.
(5) to declare the summary information of product production, sales and application.
At the same time, the purpose and use of the product should be explained.
(6) Declare the information of product production technology and main production and inspection equipment.
(1) Production process data shall include process flow chart, starting materials, organic solvents, production conditions (temperature, pressure, time, catalyst, etc.). ) and operation steps, as well as the main physical and chemical properties of raw materials and products, and indicate the impurities or other intermediate products that may be produced in the production process.
The sealing method of plastic infusion bottle products should be explained, and the verification data of cleaning process and sealing should be provided.
② Data of production and inspection equipment can be submitted in the following form.
List of production equipment for pharmaceutical packaging materials
Serial number device name? Model number? Quantity? Go to the factory
List of inspection equipment for packaging materials
Serial number device name? Model number? Quantity? Go to the factory
(7) declare product quality standards
① For varieties implementing YBB series standards issued by the US Food and Drug Administration, a copy of the standards implemented shall be provided.
(2) For varieties implementing self-made standards, draft standards and drafting instructions shall be provided, and the format shall conform to YBB series standards of the US Food and Drug Administration, and its terms and measurement units shall be used.
③ Product structure diagram should be attached.
(4) At the same time, the quality standard of the parts shall be submitted when the parts are declared.
(8) Declared the self-inspection reports of three batches of product manufacturers.
Self-inspection reports of three consecutive batches of samples shall be provided. If there are inspection items entrusted to other units, it shall be explained. This information needs to be submitted in original form.
(9) Research data of drug stability test (drug compatibility test) packaged with the declared product.
① Simulate the packaging on the market for testing, and pay attention to the selection of representative test drugs. The stability inspection items of the tested drugs should refer to Appendix XIX of China Pharmacopoeia (2000 edition)? Item setting of corresponding dosage forms in the Table of Key Investigation Items on Stability of Raw Materials and Pharmaceutical Preparations. The items set shall not be short of important items such as content, related substances, moisture and particle size detection, and shall not be reduced or changed at will.
(2) The quality standard of the test article shall be attached.
(3) The drug batch number and the name, specification and batch number of the packaging materials shall be indispensable. (Several batches of packaging materials and several batches of medicines)
④ Provide 6-month accelerated test or 12-month long-term test results.
⑤ In the test results, the items that can give specific values should be represented by numbers, and the words "in compliance with regulations" cannot be used instead. Sampling points for accelerated test and long-term test shall comply with the provisions of Appendix XIX of China Pharmacopoeia (2000 edition)? C match.
⑥ Recommended accelerated test conditions
⑦ The placement position of the sample, such as vertical, inverted or horizontal, shall be stated. Rubber stopper products should be tested backwards.
Today, this information needs to be submitted in original form.
Eight. Schematic diagram of bidding process:
Nine, licensing procedures:
(1) Acceptance:
The applicant shall apply to the acceptance department of the Provincial Bureau and submit the application materials according to the catalogue listed in Article 6 of this notice. The staff will conduct formal examination of the application materials according to the requirements of Annex 2: Application Materials for the Production of Pharmaceutical Packaging Materials in the Measures for the Administration of Packaging Materials and Containers in Direct Contact with Drugs. If the application does not need to obtain an administrative license according to law, it shall immediately inform the applicant that it will not be accepted; If the application matters do not fall within the scope of functions and powers of the administrative organ according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ; If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot; If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within five days. If the application materials are not informed within the time limit, it shall be accepted as of the date of receipt of the application materials; If the application matters fall within the scope of functions and powers of the administrative organ, the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials according to the requirements of the administrative organ, the application for administrative license shall be accepted.
(2) On-site inspection:
After completing the examination, the provincial food and drug administration shall organize an on-site inspection of the production enterprise within 30 days, continuously take three batches of samples, and notify the packaging material inspection agency to conduct registration inspection.
(3) check:
The packaging material inspection agency shall inspect the samples within 30 days after receiving the registration inspection notice and samples, issue inspection reports and put forward opinions, report to the provincial food and drug administration and notify the applicant. (The registration inspection of new packaging materials should be completed within 60 days. )
(4) Data transmission:
The provincial food and drug administration shall, within 10 days after receiving the inspection report and relevant opinions from the packaging material inspection agency, submit the formal review opinions, on-site inspection opinions and inspection reports, other opinions and the materials and samples submitted by the applicant to the State Food and Drug Administration of the United States.
(5) Technical review:
The State Food and Drug Administration shall organize the technical review within 80 days after receiving the information. (If supplementary information is needed, the State Food and Drug Administration will inform the applicant at one time, and the applicant shall complete it at one time within 4 months. )
(six) administrative licensing decision:
The State Food and Drug Administration shall complete the examination and approval within 20 days after completing the technical review. Decide whether to agree or not in the form of "Registration Certificate of Pharmaceutical Packaging Materials"; If it decides not to agree, it shall explain the reasons and issue a notice of consent; If it is necessary to renew the Registration Certificate for Pharmaceutical Packaging Materials or the Registration Certificate for Imported Pharmaceutical Packaging Materials, the cancellation of the original certificate shall be announced after the renewal of the new certificate. (Note: The State Food and Drug Administration of the United States will complete the examination and approval within 20 days after completing the technical review; If the examination and approval is not completed within 20 days, it may be extended by 10 days with the approval of the leader of the competent bureau; If the extension period exceeds 10 days, it shall be reported to the State Council for approval.
(7) Services:
Within 10 days after the decision of administrative license is made, SFDA administrative acceptance service center will serve the decision of administrative license to the applicant.
(8) Review:
If the applicant disagrees with the decision not to approve, he can file a review with the US Food and Drug Administration within 10 days after receiving the approval decision. The contents of the review are limited to the original application, the original submitted materials and samples.
After receiving the application for reexamination, the State Food and Drug Administration of the United States shall make a reexamination decision within 50 days. If it decides to cancel the original decision of disapproval, it shall issue the corresponding approval documents for the packaging materials; If it is decided to maintain the original decision, the US Food and Drug Administration will no longer accept the application for review.
X. Time limit for commitment:
The administrative licensing decision shall be made within 170/200 days from the date of acceptance. But it does not include the time required for the applicant to supplement the information. (Note: The State Food and Drug Administration of the United States will complete the examination and approval within 20 days after completing the technical review; If the examination and approval is not completed within 20 days, it may be extended by 10 days with the approval of the leader of the competent bureau; If the extension period exceeds 10 days, it shall be reported to the State Council for approval. )
XI。 Executing agency:
Implementing agency: US Food and Drug Administration Province
Place of acceptance: all provincial food and drug supervision and management departments
Twelve, the validity and extension of the license:
The validity period of the Registration Certificate of Packaging Materials or the Registration Certificate of Imported Packaging Materials issued by the US Food and Drug Administration is 5 years. If it is necessary to continue production or import after the expiration of the validity period, the applicant shall apply for re-registration six months before the expiration of the validity period.
The validity period of the supplementary application for packaging materials is the same as that of the registration certificate for packaging materials.
Thirteen. Annual inspection or license inspection: none.
Fourteen, accept the consultation and complaint institutions:
Negotiation: US Food and Drug Administration State
Complaints: State Supervision Bureau of US Food and Drug Administration, Law Enforcement Supervision Department of Policy and Regulation Department
Note: The working period of this notice is calculated on working days, excluding legal holidays.