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Laws & Regulations - Drugs - Provisions for Registration of Pharmaceutical Preparations in Medical Institutions (Trial)
Provisions for Registration of Pharmaceutical Preparations in Medical Institutions (Trial)
 
2012/3/20 14:35:03¡¡Source: ¡¡Hits:

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 repo

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