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Pharmaceutical & Cosmetic
Provisions for Registration of Pharmaceutical Preparations in Medical Institutions (Trial)
    Pubtime: 2012-03-20

Chapter 1 General Provisions
Article 1 These Provisions are formulated for the purpose of strengthening administration of pharmaceutical preparations in medical institutions and standardizing application and approval of pharmaceutical preparations in medical institutions in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Drug Administration Law) and the Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Regulations for the Implementation of the Drug Administration Law) .
Article 2 The Provisions apply to application for preparation, transfer allocation and use of pharmaceutical preparations in medical institutions within the territory of the People’s Republic of China as well as the relevant examination, approval, testing and supervision thereof.
Article 3 Pharmaceutical preparations in medical institutions refer to pharmaceutical preparations based on fixed formula which have been prepared upon approval by medical institutions according to their own clinical needs for their own use.
Pharmaceutical preparations in medical institutions shall be those unavailable on the market.
Article 4 The State Food and Drug Administration is responsible for the supervision of pharmaceutical preparations in medical institutions nationwide.
The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for approval and supervision of pharmaceutical preparations in medical institutions within their respective jurisdiction.
Article 5 An applicant for a pharmaceutical preparation of medical institution shall be a medical institution holding a Practicing License of Medical Institution and a Pharmaceutical Preparation Certificate for Medical Institution.
A “hospital”-type medical institution that has not obtained the Pharmaceutical Preparation Certificate for Medical Institution or whose Pharmaceutical Preparation Certificate for Medical Institution does not cover the relevant dosage form of the preparation may apply for a traditional Chinese medicine preparation of medical institution, and an application for contract preparing of the preparation must be filed at the same time. The entrustee shall be a medical institution with the Pharmaceutical Preparation Certificate for Medical Institution or a drug manufacturer who has obtained the certificate of Good Manufacturing Practice for Pharmaceutical Products. The dosage form of a contracted preparation shall be consistent with that indicated in the Pharmaceutical Preparation Certificate for Medical Institution or the certificate of Good Manufacturing Practice for Pharmaceutical Products held by the entrustee.
Article 6 A pharmaceutical preparation of medical institution can only be used within the medical institution in the presence of a prescription written by a licensed doctor or licensed assistant doctor, and shall be consistent with the scope of diagnosis and treatment specified in the Practicing License of Medical Institution.

Chapter 2 Application and Approval
Article 7 Pre-clinical trial for application of a pharmaceutical preparation of medical institution includes formula screening, preparation processes and quality specifications and pharmacological and toxicological study.
Article 8 The application dossier for registration of a pharmaceutical preparation of medical institution shall be authentic, complete and normative.
Article 9 Drug substances and Chinese crude drugs and prepared slices of Chinese crude drugs regulated by approval numbers, which are used for applying pharmaceutical preparations, must come with drug approval numbers and conform to official drug specifications.
Article 10 For a preparation for which the registration is applied or for its formula, process or use, the applicant shall provide explanations on the status of its own or others’ patent in China as well as the ownership. Where others possess a patent in China, the applicant shall submit a statement of non-infringement upon the patent thereof.
Article 11 A pharmaceutical preparation of medical institution shall be named according to the drug nomenclature promulgated by the State Food and Drug Administration and shall not be named in its trade name.
Article 12 Excipients used for a pharmaceutical preparation of medical institution, immediate packaging materials and containers shall meet provisions of the State Food and Drug Administration relating to recipients,immediate packaging materials and containers.
Article 13 The insert sheet and package label of a pharmaceutical preparation of medical institution shall be approved, along with the application for the preparation, by the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government according to materials submitted by the applicant.
The insert sheet and package label of a pharmaceutical preparation of medical institution shall be printed in accordance with the provisions of the State Food and Drug Administration relating to drug insert sheets and package; the label, text and patterns shall not go beyond what is approved, and the sentence “This preparation is to be used in this medical institution only” shall be marked.
Article 14 In any of the following circumstances, a pharmaceutical preparation shall not be applied for as a pharmaceutical preparation of medical institution.
(1) a product already available in the market;
(2) a product containing an active ingredient unapproved by the State Food and Drug Administration;
(3) a biological product other than an allergen;
(4) a traditional Chinese medicine injection;
(5) a compound preparation made of traditional Chinese medicines and chemical drugs;
(6) a narcotic drug, a psychotropic drug, a toxic drug for medical use, or a radioactive pharmaceutical;
(7) a preparation of other types not meeting relevant regulations of the State.
Article 15 To apply for preparing a pharmaceutical preparation in a medical institution, the applicant shall complete the Application Form for Registration of Pharmaceutical Preparations in Medical Institutions and submit it along with relevant materials and samples of the preparation to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or an entrusted municipal (food and) drug regulatory department in a city consisting of districts.
Article 16 After an application is received, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the entrusted municipal (food and) drug regulatory department in a city consisting of districts shall conduct preliminary review on the application dossier. Where the application meets the requirements, it shall be accepted; where the application does not meet the requirements, the department shall provide a written notification and explain reasons thereof to the applicant within 5 days after receiving the application dossier. Where the applicant is not informed within the timeline, the application is regarded as accepted on the date the dossier is received.
Article 17 Within 10 days from the date an application is accepted, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government or the entrusted municipal (food and) drug regulatory department in a city consisting of districts shall organize an on-site inspection to take samples from 3 consecutive batches for testing and notify the designated drug testing institute to conduct sample testing and technical review of drug specifications. Upon completion of the abovementioned steps, the entrusted municipal (food and) drug regulatory department in a city consisting of districts shall submit its opinions, the inspection report and application dossier to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, and notify the applicant.
Article 18 Within 40 days from the date the notice for testing is received, a drug testing institute shall complete sample testing and technical review of drug specifications, provide the testing report and its opinions on the review of drug specifications, submit them to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, and copy to the applicant and the (food and) drug regulatory department issuing the test notification..
Article 19 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall organize and complete its technical review within 40 days from the date it receives all the materials, and issue a Permit for Clinical Study of Pharmaceutical Preparation of Medical Institution if the application is in conformity with relevant provisions.
A chemical preparation may be exempt from clinical study in the application if an approval number has been obtained for a preparation of the same variety.
Article 20 A pharmaceutical preparation used for clinical study shall be prepared in accordance with the Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions or the Good Manufacturing Practice for Pharmaceutical Products. The pharmaceutical preparation shall meet the specifications approved by the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government.
Article 21 Clinical study of a pharmaceutical preparation of medical institution shall be conducted in accordance with the Good Clinical Practice after a Permit for Clinical Study of Pharmaceutical Preparation of Medical Institution has been acquired and an informed consent of the subject and permission of the ethics committee have been obtained.
Article 22 Clinical study of a pharmaceutical preparation of medical institution shall be conducted at the medical institution in accordance with the clinical study/trial protocol. The number of subjects shall be no less than 60.
Article 23 After a clinical study is completed, the applicant shall submit a summary of the clinical study to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the entrusted municipal (food and) drug regulatory department in a city consisting of districts.
Article 24 Within 40 days from the date all the application materials are received, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall complete technical review and decide whether to grant a permission. For an application in conformity with relevant provisions, the department shall issue an Approval for Registration of Pharmaceutical Preparations in Medical Institutions and an approval number for the preparation to the applicant within 10 days from the date the decision is made, and meanwhile report to the State Food and Drug Administration for the record; for an application not in conformity with relevant provisions, the department shall notify the applicant in writing with the reasons thereof, and inform the applicant of the right to apply for administrative reconsideration or to bring an administrative suit by law.
Article 25 Format of an approval number for a pharmaceutical preparation of medical institution is as follows:
X (YaoZhiZi) H (Z) +4-digit year + 4-digit serial number.
X— one-character abbreviation of the province, autonomous region or municipality directly under the Central Government
H—chemical preparation
Z—traditional Chinese medicine preparation
Chapter 3 Transfer Allocation and Use
Article 26 Pharmaceutical preparations in medical institutions shall not be transferred in general. Where a disaster, epidemic or emergency occurs, or there is an urgent clinical need for a pharmaceutical preparation unavailable on market, when transfer allocation and use is needed, transfer allocation of the pharmaceutical preparation of medical institutions within a provincial jurisdiction must be approved by the local food (and drug) regulatory department of the province, autonomous region or municipality directly under the Central Government; transfer allocation of special pharmaceutical preparations specified by the State Food and Drug Administration and transfer allocation of pharmaceutical preparations among medical institutions of different provinces, autonomous regions and municipalities directly under the Central Government must be approved by the State Food and Drug Administration.
Article 27 To apply for transfer allocation of a pharmaceutical preparation of medical institution within a jurisdiction at provincial level, the user shall file an application with the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, including reason for use, duration, preparation quantity and scope of the transfer allocation, and submit relevant materials.
To apply for transfer allocation and use of a pharmaceutical preparation of medical institution among provinces, autonomous regions and municipalities directly under the Central Government or transfer allocation and use of a special pharmaceutical preparation specified by the State Food and Drug Administration, a medical institution that has obtained an approval number for the preparation shall file an application, including reason for use, duration, preparation quantity and scope of the transfer allocation, to the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government. After the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government has reviewed and approved the application, the user shall submit review opinions along with relevant materials to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the user is located, and submit them to the State Food and Drug Administration for approval after examination and permission from the department.
Article 28 A medical institution which has obtained an approval number for a pharmaceutical preparation to be transferred shall be responsible for the quality of the transferred preparation. The medical institution accepting the transferred pharmaceutical preparation shall strictly follow the instruction when using the pharmaceutical preparation and be responsible for all the consequences arising from use beyond the scope or improper use.
Article 29 Transfer allocation and use of a pharmaceutical preparation of medical institution shall not exceed the specified duration, quantity and scope.

Chapter 4 Supplementary Application and Re-registration
Article 30 A medical institution shall strictly follow the approved specifications when preparing a pharmaceutical preparation and shall not change the process, formula, preparation site and entrustee without permission. Where any change is needed, the applicant shall file a supplementary application and submit relevant materials, and may only make the change upon approval.
Article 31 The approval number for a pharmaceutical preparation of medical institution is valid for 3 years. Upon expiration, where there is a need to continue preparing, the applicant shall apply for re-registration and submit relevant materials no less than 3 months prior to expiration according to the original application procedure for the preparing.
Article 32 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall decide whether to approve a re-registration within 30 days from the date the application is accepted. If a re-registration is approved, the department shall notify the applicant, renew the Approval, and report to the State Food and Drug Administration for the record within 10 days from the date the decision is made.
If a re-registration is not approved, the department shall notify the applicant and explain the reason thereof in writing, and meanwhile inform the applicant of the right to apply for administrative reconsideration or to bring an administrative suit by law.
Article 33 In any of the following circumstances, the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall not approve re-registration and cancel the approval number of the preparation.
(1) The product is already available in the market;
(2) The approval number is withdrawn in accordance with the Provisions;
(3) Failure to file an application for re-registration within the specified time;
(4) Other cases of noncompliance.
Article 34 A pharmaceutical preparation, of which the approval number has been cancelled, shall not be prepared and used; those already prepared shall be destroyed or handled under the supervision of the local (food and) drug regulatory department.
Chapter 5 Supervision
Article 35 A medical institution preparing and using pharmaceutical preparations shall observe adverse reaction(s) of pharmaceutical preparations, report and handle the reaction(s) in accordance with relevant regulations of the State Food and Drug Administration.
Article 36 The (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall order a medical institution to stop making a pharmaceutical preparation harmful to human health due to unstable quality, unreliable therapeutic effects, remarkable adverse reaction or other causes, and withdraw the approval number for the preparation.
Any pharmaceutical preparations, of which approval numbers have been withdrawn, shall not be prepared and used; those already prepared shall be destroyed or handled under the supervision of the local (food and) drug regulatory department.
Article 37 Sampling and testing of pharmaceutical preparations in medical institutions shall be conducted in accordance with relevant provisions of the State Food and Drug Administration.
Article 38 Where a medical institution is no longer qualified for making a pharmaceutical preparation, the obtained approval number for the preparation shall lose their validity and be cancelled by the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, with the exception of approval number of a traditional Chinese medicine preparation allowing contract preparing. To continue preparing a traditional Chinese medicine preparation allowing contract preparing, the medical institution may file a supplementary application for contract preparing with reference to requirements for changing entrustee in Article 30 of the Provisions.
Article 39 A medical institution that uses a pharmaceutical preparation made by another medical institution without approval shall be punished in accordance with provisions in Article 80 of the Drug Administration Law.
Article 40 Any medical institution that violates Article 48 and Article 49 of the Drug Administration Law in making pharmaceutical preparations shall be published in accordance with Article 74 and Article 75 of the Drug Administration Law respectively.
A medical institution that fails to follow specifications approved by the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government in making a pharmaceutical preparations shall fall into the category of other cases where a preparation is not in conformity with the drug standards as described in Item 6, Paragraph 3 of Article 49 of the Drug Administration Law, and shall be punished in accordance with Article 75 of the Drug Administration Law.
Article 41 Where false proof documents, application materials and samples are provided or other deceptive means are used for application of approval documents, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall not accept the application, and shall give a warning to the applicant, whose application for such approval documents shall not be accepted within one year. Where the approval documents have been obtained, the department shall withdraw the approval documents, and shall not accept the application within five years and impose a fine of no less than RMB 10,000 yuan but no more than RMB 30,000 yuan.
Article 42 A pharmaceutical preparation of medical institution shall not be sold on the market or sold in any disguised form. Advertisements for a pharmaceutical preparation of medical institution are prohibited.
A medical institution that sells a pharmaceutical preparation made by itself on the market or sells in any disguised form shall be punished in accordance with Article 84 of the Drug Administration Law.
Article 43 Where the (food and) drug regulatory department of a province, autonomous region or municipality directly under the Central Government conducts any administrative act in violation of the Provisions, the State Food and Drug Administration shall order them to make corrections within a time limit; where the correction is not made within the time limit, the State Food and Drug Administration shall make the correction or withdrawal.

Chapter 6 Supplementary Provisions
Article 44 In the Provisions, the time limit for exercising a permission by administrative authorities is calculated by working days, excluding official holidays.
Article 45 “Pharmaceutical Preparations of fixed formula” mentioned in the Provisions are the kind of preparations with fixed formula, mature preparation processes and long-term clinical application use for a certain disease.
Article 46 The (Food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may formulate detailed implementing rules in view of local conditions.
Article 47 The Provisions shall go into effect as of August 1, 2005.

List of Appendices
1. Application Dossier Requirements for Registration of Pharmaceutical Preparation of Medical Institution
2. Items of Application Dossier for Transfer Allocation and Use of Pharmaceutical Preparation of Medical Institution
3. Items of Application Dossier for Re-registration of Pharmaceutical Preparation of Medical Institution
4. Application Form and Format of Approval Document of Pharmaceutical Preparation of Medical Institution

Appendix 1:
Application Dossier Requirements for Registration of Pharmaceutical Preparation of Medical Institution

Ⅰ. Items of Application Dossier
1. Name of preparation and basis of nomenclature.
2. Purpose of application and market supply of the variety to be prepared.
3. Proof documents.
4. Design sample of the label and insert sheet.
5. Composition, source, theoretical basis and background of the formula.
6. Research data and literature of preparation processes.
7. Data and literature of quality study.
8. Draft of quality specifications of the preparation and drafting explanation.
9. Stability testing data of the preparation.
10. Self-test report of samples.
11. Source and quality specifications of excipients.
12. Rationale for selection and specifications of immediate packaging materials and containers.
13. Data and literatures of primary pharmacodynamics testing.
14. Data and literatures of acute toxicity testing.
15. Data and literatures of chronic toxicity testing.
16. Clinical trial protocol.
17. Clinical trial report.
Ⅱ Explanations
1. Proof documents in Item 3 of Application Dossier includes:
(1) Photocopies of the Medical Institution License and Pharmaceutical Preparation Certificate for Medical Institution;
(2) Description of the patent of the preparation of medical institution or its formula and process in practice, explanations of the ownership of the patent, and statement of non-infringement upon patents of others;
(3) Documents proving the legitimate source of drug substances, including photocopies of approval documents of drug substances, invoice for sales, testing report and drug specifications;
(4) Photocopies of registration certificates of immediate packaging materials and containers;
(5) Photocopies of the Approval for Clinical Study of Pharmaceutical Preparation of Medical Institution.
(6) A “hospital”-type medical institution that has not obtained the Pharmaceutical Preparation Certificate for Medical Institution or whose Pharmaceutical Preparation Certificate for Medical Institution does not cover the relevant dosage form of the preparation may apply for a traditional Chinese medicine preparation in medical institution by providing the following materials: photocopies of the contract for contract preparing of traditional Chinese medicine preparations and Pharmaceutical Preparation Certificate for Medical Institution or certificate of Good Manufacturing Practice for Pharmaceutical Products of the entrustor.
2. Chinese medicine terms and names of diseases in traditional Chinese medicine shall be used in describing functions of traditional Chinese medicine preparations.
3. Chinese medicine preparations shall be compared with varieties adopted in national drug standards in the following areas:
(1) Composition;
(2) Theoretical features;
(3) Functions (indications).
4. “Self-testing report of samples” in Item 10 of Application Dossier refers to the testing report issued by the medical institution after the pharmaceutical preparation test. Self-testing report for samples taken from 3 consecutive batches shall be provided before submission of preclinical study data. While applying for traditional Chinese medicine preparations in medical institutions, any “Hospital”-type medical institution that has not obtained the Pharmaceutical Preparation Certificate for Medical Institution or whose Pharmaceutical Preparation Certificate for Medical Institution does not cover relevant dosage forms of pharmaceutical preparations shall provide a self-test report issued by the entrustee for samples taken from 3 consecutive batches
5. Where a Chinese medicine preparation is made with traditional processes (i.e. material base for treating diseases in the original formulation is not changed during the process of preparation, and its composition is made according to traditional Chinese medicine theory and used for more than 5 years (including 5 years) in the medical institution, it may be exempted from Item 13-17 of Application Dossier.
(1) The formulation contains crude drugs identified as toxic in mandatory standards or those proved to be toxic by modern toxicology;
(2) The formulation contains Shi Ba Fan and Shi Jiu Weiin compatibles ;
(3) Quantity of Chinese crude drugs in the formula exceeds what is prescribed in drug standards.
6. Where a chemical preparation to be applied for preparing is one that a same variety has already obtained an approval number, it may be exempted from Item 13-17 of Application Dossier.
7. Non-clinical application dossier includes Item 1-16.
8. Reports of self-testing on samples taken from 3 consecutive batches shall be submitted with clinical trial summary. The self-testing shall be conducted according to the verified quality specifications.
9. Application documents shall be printed on A4 size paper and provided in triplicate.

Appendix 2:
Items of Application Dossier for Transfer Allocation and Use of Pharmaceutical Preparation of Medical Institution
1. Photocopies of the Medical Institution License of both provider and receiver in the transfer allocation and use; photocopies of the Pharmaceutical Preparation Certificate for Medical Institution of the preparation provider. As to the approved traditional Chinese medicine preparation in a medical institution, which is made by an entrustee, photocopies of the Pharmaceutical Preparation Certificate for Medical Institution or certificate of Good Manufacturing Practice for Pharmaceutical Products of the entrustee shall be provided.;
2. Photocopy of the Approval Letter for Registration of Pharmaceutical Preparation of Medical Institution of the pharmaceutical preparation to be transferred;
3. Contract between the two parties involved in the transfer allocation and use;
4. Reason, duration and scope of the transfer allocation and use, quantity of the pharmaceutical preparation to be transferred;
5. Quality specifications, insert sheet and label of the pharmaceutical preparation to be transferred;
6. Self-testing report of the pharmaceutical preparation to be transferred issued by the provider;
7. Where the provider and receiver are from different provinces, the drug regulatory department at provincial level in the place the receiver is located, shall be responsible for reviewing and submitting application materials along with opinions of the drug regulatory department at provincial level in the place the provider is located.

Appendix 3:
Items of Application Dossier for Re-registration of Pharmaceutical Preparation of Medical Institution
1. Proof Documents;
(1) Approval document/letter for the pharmaceutical preparation and approval document/letter issued by the (food and) drug regulatory department for any change; document for any change approved by the (food and) drug regulatory department
(2) Photocopies of Pharmaceutical Preparation Certificate for Medical Institution. Photocopies of the Pharmaceutical Preparation Certificate for Medical Institution or certificate of Good Manufacturing Practice for Pharmaceutical Products shall be provided for the contracted pharmaceutical preparation by the entrustee with permission from relevant authorities;
2. Summary of clinical use and adverse reaction of the pharmaceutical preparation for the past 3 years;
3. Formula, processes and specifications of the pharmaceutical preparation;
4. Source of drug substances used for the pharmaceutical preparation.

Application Form for Registration of Pharmaceutical Preparation of Medical Institution

Name of pharmaceutical preparation:

Applicant: (Official seal)

Designed by the State Food and Drug Administration


Instructions

1. Name of the applicant should be consistent with the name indicated in the Medical Institution License.

2. Forms should be filled out in simplified Chinese, except for necessary English words. The words and expressions shall be concise and accurate.

3. Classification of pharmaceutical preparations: pharmaceutical preparations shall be marked as pharmaceutical chemicals, traditional Chinese medicine or biological products.

4. Excipients: each excipient used in the prescription shall be filled in, including colorant, preservative, spice and corrective. Prescribed doses are calculated by the unit of 1000 pharmaceutical preparations.

5. Contract preparing: a “Hospital”-type medical institution, who has not obtained the Pharmaceutical Preparation Certificate for Medical Institution or whose Pharmaceutical Preparation Certificate for Medical Institution does not cover the dosage form of the pharmaceutical preparation, shall fill out relevant parts of the form when applying for a Chinese medicine preparation in medical institution.

6. This form shall be printed with A4 size paper and provided in triplicate.



Name of pharmaceutical preparation

Generic name

Pinyin

Category of pharmaceutical preparation

Dosage form

Specification

Preparation contracted or not (Y/N)

Formula(including excipients used)

Preparation processes (including excipients used)

Indications or functions

Dosage and Usage

Applicant

Name of Institution

Number of the Pharmaceutical Preparation Certificate for Medical Institution

Preparation site

Contact person

(Signature)

Tel

Entrustee

Name of Entrustee

Number of the Pharmaceutical Preparation Certificate for Medical Institution (or certificate of Good Manufacturing Practice for Pharmaceutical Products)

Preparation site

Legal representative

(Signature and official seal)

Contact person

(Signature)


Stability testing research/study project and conclusion

Primary pharmacodynamics research/study and conclusions

Toxicological research/study project and conclusion

Opinion of the committee of pharmaceutical affairs administration

(Signature):

Date:

Materials attached

1□2□3□4□5□6□7□8□9□10□11□12□13□14□15□16□17□

Statement

We guarantee that: ①The application complies with laws, regulations and rules including the 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 Administrative, Provisions for Registration of Pharmaceutical Preparations in Medical Institutions; ② Any contents or attached materials and samples associated with this Form are correct and lawful, with no infringement upon others’ rights and interests, and any data in the attached materials are results of method, research and tests conducted on the drug; ③ If any false information is found in this Form and attached materials, we will bear all the legal consequences thereof.

Applicant:

Legal representative (signature):

Date: (official seal)


Permit for Clinical Study of Pharmaceutical Preparation of Medical Institution

Acceptance No.: Approval No.:

Name of pharmaceutical preparation

Generic name

Pinyin

Category of the pharmaceutical preparation

Dosage form

Specification

Applicant

Name of institution

Number of the Pharmaceutical Preparation Certificate for Medical Institution

Preparation site

Entrustee

Name of entrustee

Number of the Pharmaceutical Preparation Certificate for Medical Institution (or certificate of Good Manufacturing Practice for Pharmaceutical Products )

Preparation site

Review result

Send to

Copy to

Appendices

Remark

(Food and) drug regulatory department

Date:
Approval Letter for Registration of Pharmaceutical Preparation of Medical Institution

Acceptance No.: Approval No.:

Name of pharmaceutical preparation

Generic name

Pinyin

Category of pharmaceutical preparation

Dosage form

Specification

Validity period

Applicant

Name of institution

Number of the Pharmaceutical Preparation Certificate for Medical Institution

Preparation site

Entrustee

Name of entrustee

Number of the Pharmaceutical Preparation Certificate for Medical Institution (or certificate of Good Manufacturing Practice for Pharmaceutical Products)

Preparation site

Review result

Approval number

Validity period of the approval number

Until year month day

Send to

Report to

State Food and Drug Administration

Copy to

Appendices

Quality specifications, insert sheet and label

Remark

(Food and) drug regulatory department

Date:


Application Form for Transfer Allocation and Use of Pharmaceutical Preparation of Medical Institution

Acceptance No.:

Approval No.:

Name of pharmaceutical preparation

Dosage form

Specification

Validity period

Quality specifications

Batch number

Approval number

Reason for application

Scope of application

Quantity of the pharmaceutical preparation transferred

Duration of use

Until year month day

Provider

Receiver

Name of medical institution

Address of medical institution

Name of preparing institution

―――――――――

Address of

preparation site

―――――――――

Number of the Pharmaceutical Preparation Certificate for Medical Institution (or certificate of Good Manufacturing Practice for Pharmaceutical Products )

―――――――――

Contact person

Tel

Legal representative

(Signature and official seal)

Date:

(Signature and official seal)

Date:


Approval Letter for Transfer Allocation and Use of Pharmaceutical Preparation of Medical Institution

The following pharmaceutical preparation in medical institution is hereby approved according to the Provisions for the Registration of Pharmaceutical Preparations in Medical Institutions (Trial) and relevant regulations and shall be transferred and used according to the following items.

Acceptance No.: Approval No.:

Name of pharmaceutical preparation

Dosage form

Specification

Validity period

Quality specifications

Batch number

Approval number

Quantity of pharmaceutical preparation to be transferred

Scope of application

Duration of use

Provider

Name of institution

Address

Name of preparing institution

Preparation site

Receiver

Name of institution

Address

Validity period

The approval letter can be used once before year month day

Send to

Copy to

Appendices

Quality specifications, insert sheet and label

Remark

(Food and) drug regulatory department

Date:


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