Chapter 1 Total
The first article According to Article 22 of the "Regulations on the Administrative Protection of Drugs" (hereinafter referred to as the Regulations)，Formation of this detail。
Article 2 The administrative agency that fulfills the drug administrative protection function in accordance with the regulations is the State Drug Administration。
Article 3 The State Drug Administration set up a drug administrative protection office，Specific responsibilities:
(1) Application for administrative protection for drugs for acceptance and review of drugs、Drug Administrative Protection Cancellation Application、Infringement processing application;
(2) Speaking of authorization or rejection;
(3) Put up opinions on the revocation and infringement treatment of drug administrative protection;
(4) Establish a registry，Application for drug administrative protection、Authorized、Reject、Return、Termination and other matters to register;
(5) Acceptance of drug administrative protection、Authorized、Reject、Return、Termination, etc. Announcement;
(6) Do to handle other tasks related to drug administrative protection。
Article 4 The drug exclusive owner referred to the regulations refers to the manufacture of drugs applying for administrative protection、Use and sell people who have full rights。
Article 5 The drug referred to the regulations refers to the use of prevention、Treatment、Diagnostic disease，Destinations to regulate people's physiological functions and stipulate that there are indications、Materials for usage and dosage。
Chapter 2 Application of administrative protection
Article 6 Regulations Article 5, paragraph 3, paragraph 3, have not yet been sold in China, referring to the drug circulation market that has not yet entered the drug circulation of administrative protection.。
Article 7 Regulations Article 7 The agency refers to the agency designated by the State Drug Administration。
Article 8 Application of Drug Administrative Protection and Format of other administrative protection documents，Uniformly formulated by the State Drug Administration。
Article 9 Regulations stipulated in Article 8 of the Regulations refer to the official stake betting applanguage of the applicant's country。
Article 10 When the applicant applies for the application of drug administrative protection，It should be entrusted to the agency of China to handle，Signed a attorney，Remark the entrusted authority。
When submitted by the agency Article 8 and the application documents stipulated in this rules,，Should be submitted at the same time the applicant's attorney。
Article 11 A drug administrative protection application is limited to only one drug.
Article 12 Regulations Article 8 Paragraph 1 Pharmaceutical Administrative Protection Application Form，The following matters should be provided:
(1) Applicant name, address;
(2) The nationality of the applicant;
(3) The applicant is an enterprise or other organizations，The country or region where its headquarters is located;
(4) The name of the medicine for administrative protection (universal name、Commodity name、Chemical name)、Chemical structure formula、Formula、Dosage form、Indications、Usage、Dosage、Craft Preparation Method Introduction;
(5) Signature (seal) of applicants and agency;
(6) List of the application file;
(7) Other matters that need to be indicated.
Article 13 The application file should be neat and clear，Figures should be standard specifications，Do not change。
The technology terms involved in the application document shall adopt the unified regulatory term of China。
Article 14 The applicant submits (2) specified in Article 8 of the Regulations of the applicant、(3) item file，Should apply for the corresponding notarization in its country、Certification or certification procedures。
The (4) document specified in Article 8 of the applicant's submission of the Regulations，Notarization of notarized agencies in China。
Article 15 The (4) documents stipulated in Article 8 of the Regulations submitted by the applicant are the production of a drug contract，Chinese corporate legal persons who signed a contract with them must hold the "Pharmaceutical Production Enterprise License" and "Business Legal Business License"; the applicant submits the sales of the drug contract，Chinese corporate legal persons who signed a contract with them must hold the "Pharmaceutical Business Enterprise License" and "Business Legal Business License"。
When the applicant submits a manufacturing or sales contract, the above certificate must be attached by Chinese corporate legal person、Photoply print。
Article 16 Applicants submit a drug administrative protection application，Relevant documents should be submitted，There is one of the following situations，The State Drug Administration will not accept:
(1) If the format that is not used in use or fills in the regulations;
(2) Those who have not submitted relevant documents in accordance with regulations.
Article 17 Before obtaining a drug administrative protection certificate，The applicant requires the withdrawal of the application of the drug administrative protection，It should submit a written application to the State Drug Administration，Write the name and drug name of the applicant。
Chapter 3 The term, termination, cancellation and effectiveness of administrative protection
Article 18 Regulations Article 13 The date of issuance of drug administrative protection certificates Stake Sports Bettingreferred to，refers to the date stated on the administrative protection certificate of the drug。
Article 19 Regulations and announcements stipulated in this rules，announced by the State Drug Administration。
Article 20 During the administrative protection period of the drug，Drug exclusively shall submit to the State Drug Administration to submit the proof documents for the continuous and effective administration of drug exclusive rights。
Article 21 According to the provisions of Article 15 of the Regulations，Request to revoke the administrative protection of drugs，shall submit to the State Drug Administration for the "Request to Course Drug Administration Protection" and the relevant certification documents in two copies。
"Request for the Revisibility of Drug Administration" should be stated that the following matters:
(1) The name, address and nationality of the requestant;
(2) The name and address of the requestant;
(3) The name and authorization number of the drug that was requested to be revoked;
(4) Reasons and evidence of requesting cancellation.
An application for revoking drug administrative protection is limited to a drug that is protected by administrative protection。
Article 22 After the National Drug Administration received the "Request to the Drug Administration Protection"，It should be reviewed。The fact that the fact that the drug administrative protection is notified in the "Rejuvenation of the Administrative Protection of Drugs" is not stated.，No acceptance，and inform the applicant in writing; the "Rejuvenation of Drug Administration Protection" meets the conditions，It should be accepted and issued to the acceptance notice。
The State Drug Administration shall send the copy of the acceptance of the receiving drug administrative protection request and the copy of the relevant certification documents，Requires it to state opinions within the specified period。If the requesting person does not say on schedule，Do not affect the review of the State Drug Administration。
Article 23 The National Drug Administration's request to revoke the administrative protection of drugs is over，The decision to revoke the administrative protection of drugs according to the situation or the decision to withdraw the request to maintain the administrative protection of drugs，Delivery related parties，Announcement。
Article 24 Clinical research was permitted a few days ago during the application of drug administrative protection，and the same medicine approved by the State Drug Administration for the administrative protection of drugs，After the drug administrative protection authorization，You can continue to produce within the scope of approval、Sales，But you must not transfer it to a third party。
Chapter 4 Infringement treatment
Article 25 The exclusive owner who obtained the administrative protection of the drug requested the timeliness of the State Drug Administration to stop the infringement behavior of two years，Calculated from the date of infringing by the owner of the exclusive right to know or should know that the drug that is protected by the administrative protection。
Article 26 Drug exclusively applies to stop infringement behaviors，shall be submitted to "Stop Drug Administrative Protection and Inittyle
For Application ".
"Application Stake Sports Bettingfor Stop Drug Administrative Protection and Infringement" should be stated that the following matters:
(1) The applicant's name, address and nationality;
(2) The name and address of the respondent;
(3) The name and administrative protection license number of the infringed drugs;
(4) Request treatment matters;
(V) Facts and evidence of infringement.
"Application Stake Sports Bettingfor Stop Drug Administrative Protection and Infringement" should be based on the number of applicants' quantity preparation。
An application for stopping drug administrative protection infringement is limited to only one medicine。
Article 27 The National Drug Administration of the State Drug Administration of the State Drug Administration to stop the infringement application of eligible infringement，It should be accepted，and send a copy of the "Application of Drug Administrative Protection and Infringement" to send the respondent，Requires it to make a defense within the designated period。
Article 28 The State Drug Administration is as needed，Hearing that applicants and applicants who stop infringement can be held，Proof of infringement issues、Certificate and debate。
Article 29 The State Drug Administration shall make a determination on whether the behavior of the respondent constitutes an infringement。
The behavior of the respondent does not constitute infringement，The State Drug Administration shall reject the applicant's application。
The behavior of the respondent constitutes an infringement，The National Drug Administration shall stop its infringement in accordance with the law。
Article 30 Economic compensation caused by drug administrative protection infringement，Drug exclusive persons can make infringement identification in the State Drug Administration，Compensation litigation to the people's court。
Article 31 In the process of drug administrative protection and infringement process，The respondent or a third party submitted an application for cancellation of the drug administrative protection，State Drug Administration suspended infringement processing procedures，After the procedure to be revoked，Then recover or terminate the infringement processing procedure according to the situation。
Chapter 5 Fei
Article 32 Apply for drug administrative protection or handling other related matters，The following expenses should be paid separately:
(1) Application fee;
(2) review fee;
(3) Annual fee;
(4) Announcement fee;
(5) Certificate fee;
(6) Requesting fee for requesting;
(7) Infringement treatment fee;
The above -mentioned various expenses pay standards，Another announcement of the State Drug Administration。
Article 33 The applicant shall pay the application fee while submitting the application for the administrative protection of the drug; the announcement fee and review fee will be paid within one month from the date of receiving the notice of acceptance;，Its application is deemed to be withdrawn。
Article 34 Drug owners who obtain drug administrative protection shall pay the certificate fee within one month from the date of issuance of the drug administrative protection certificate、Announcement fee and annual fee of the year;，The annual fee of the year should be paid within two months of each year。If there is no reasonable reason, it will not be paid or pays insufficiently，deemed to automatically abandon administrative protection。
Article 35 Request to revoke the administrative protection of drugs，Pay the request to withdraw from the "Rejuvenation of Drug Administrative stake sports betting appProtection" when submitting the "Revolution of Drug Administrative Protection"。
Article 36 The exclusive owner who applies to stop the infringement shall pay the infringement treatment fee while submitting the "Application of the Anti -Drug Administrative Protection and Infringement"。
Article 37 This detailed rule is collected by the agency。
Chapter 6 Attach
Article 38 Regulations and various periods stipulated in these rules except for other regulations，Not calculated on the first day。
The period is calculated in the year or monthly，With its last month's corresponding day as the expiration of the end;，With the last day of the month as the expansion day。
The expiry date of the period is the legal holiday，With the first working day of the holiday after holiday, the expiry date。
Article 39 This rules are explained by the State Drug Administration.
Article 40 This rules are implemented from the date of release。December 30, 1992, the "Implementation Rules for the Implementation of the Pharmaceutical Protection Regulations" issued by the State Medical Administration at the same time。The relevant provisions published before the implementation of this rules are not consistent with this rules，The provisions of this rules are subject to。
