The State Council issued: The separation of drug production licenses affects all

Copyfrom： Release time：2018-10-12 The editor：

　　The State Council issued: The separation of drug production licenses affects all pharmaceutical companies!

The State Council issued a document that drug production license and photo separation reform will affects all pharmaceutical companies.
 
Four ways, license separation
　 On October 10, the State Council issued the "Notice on Promoting the Reform of "Separation of Licenses" in the Whole Country (hereinafter referred to as the "Notice").

　　 "Notice Display", starting from November 10, 2018, the first batch of 106 administrative examination and approval items related to enterprises in the country were changed according to the direct cancellation of examination and approval, examination and approval, filing of notifications, implementation of notification commitments, and optimization of access services. Ways to implement the "separation of licenses" reform.
　
 Cancel approval directly. The administrative examination and approval items that the establishment necessity does not exist, the market mechanism can be effectively adjusted, and the industry organization or intermediary institution can effectively realize the self-discipline management of the industry are directly canceled. After the business license is issued, business activities can be carried out.
　　
 Cancel the approval and change to the record. After the cancellation of the approval, the relevant departments need to obtain relevant information in a timely and accurate manner, which can be changed into a record. After the market entity submits the materials, the relevant business activities can be carried out, and the relevant departments will no longer approve them.
　　
 Simplify approval and implement a commitment to inform. For the time being, it is not possible to cancel the examination and approval, but through the post-event supervision, it can correct the administrative examination and approval items that do not meet the conditions for examination and approval, and implement the notification commitment. The relevant departments shall produce a letter of intent to inform and provide the applicant with a model text to inform the applicant of the conditions for approval and the required materials at one time. If the applicant promises to meet the conditions for examination and approval and submit relevant materials, it shall be examined and approved on the spot.
　　
 Improve measures to optimize access services. For administrative examination and approval matters related to major public interests such as national security, public safety, financial security, ecological security and public health, the examination and approval shall be retained and the access services shall be optimized.
 
　　 In addition to "separation of licenses", it is also necessary to "multiple certificates"
　   A business license is a legal document issued to a market entity after the registration authority confirms the market entity qualification and general business capability in accordance with the statutory conditions and procedures. A license is a certificate issued by a competent authority to a specific market entity according to law. Such market entities are required to hold business licenses and licenses to engage in specific business activities.
　
 Through the "separation of licenses" reform, the functions of "certificate" and "photo" can be effectively distinguished, so that more market entities can operate with licenses and focus on solving the problem of "access is not allowed to camp".
　
 In addition, it is subject to the "multi-integration" reform. After that, the information and items recorded in the business license are more abundant, and the market entity can carry out general business activities with the business license.
　
  All localities should make overall plans to promote the "separation of licenses" and "multi-integration" reform. In the case of the "Separation of Licenses" reform, it is a matter of information collection, record publicity, and management for investigation. In principle, it is necessary to integrate as much as possible into the business license through the "multi-certification integration" reform, and truly realize the market subject. ".
　  
 These reforms, we must pay attention
　　
 In the first batch of specific measures on the “separation of licenses” reforms implemented in the country, several medical reform-related administrative examination and approval reforms must be paid attention to by medical practitioners.
 
Domestic drug re-registration approval
 
1. Promote online business processing.
 
2. Publicize the examination and approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
3. Consolidate the relevant on-site inspections in the examination and approval of pharmaceutical production and operation licenses, and improve the efficiency of examination and approval.
 
4. Promote inter-departmental information sharing applications and strengthen post-event supervision.
　
 Approval of drug manufacturing enterprises
 
1. Promote online business processing.
 
2. Compress the time limit for approval, and compress the statutory approval time limit by one-third (on-site inspection is not included in the approval time limit).
 
3. Streamline the examination and approval materials, and obtain the materials such as the verification business license, the legal representative or the person in charge, and the identification of the person in charge of the quality.
 
4. Publicize the approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
5. Consolidate the relevant on-site inspections in the examination and approval of pharmaceutical production and operation licenses, and improve the efficiency of examination and approval.
 
6. Promote inter-departmental information sharing and application, and strengthen post-event supervision.
　　 
 
 Drug commissioned production approval
 
1. Promote online business processing.
 
2. Streamline the examination and approval materials, and obtain materials such as the verification business license, the legal representative or the identity certificate of the person in charge online.
 
3. Publicize the approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
4. Consolidate the relevant on-site inspections in the examination and approval of pharmaceutical production and operation licenses, and improve the efficiency of examination and approval.
 
5. Promote inter-departmental information sharing and application, and strengthen post-event supervision.
　
 Approval of establishment of pharmaceutical business enterprises (wholesale, retail chain headquarters)
 
1. Promote online business processing.
 
2. Compress the approval time limit and compress the legal approval time limit by one third.
 
3. Streamline the approval materials and obtain materials such as the verification business license, the legal representative or the identity certificate of the person in charge online.
 
4. Publicize the approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
5. Promote inter-departmental information sharing and application, and strengthen post-event supervision.
　　
 Drug import filing
 
1. Promote online business processing.
 
2. Streamline the examination and approval materials, obtain the verification business license online, the import drug registration certificate issued by the drug regulatory department in the administrative region or the imported drug approval, the latest import drug inspection report issued by the port drug inspection office in the administrative region, and the imported drug. Customs clearance and other materials.
 
3. Publicize the approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
4. Promote inter-departmental information sharing applications and strengthen post-event supervision.
　　
 Internet drug information service enterprise approval
 
1. Promote online business processing.
 
2. Compress the approval time limit and compress the legal approval time limit by one third.
 
3. Streamline the approval materials and obtain the verification business license and other materials online.
 
4. Publicize the approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
5. Promote inter-departmental information sharing and application, and strictly strengthen post-event supervision.
　
 Opening drug retail business approval
 
1. Promote online business processing.
 
2. Compress the approval time limit and compress the legal approval time limit by one third.
 
3. Streamline the examination and approval materials, and obtain materials such as the verification business license, the legal representative or the identity certificate of the person in charge online.
 
4. Publicize the approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
5. Promote inter-departmental information sharing and application, and strengthen post-event supervision.
　
 
               Imported medicine registration
 
1. Promote online business processing.
 
2. Streamline the examination and approval materials, and obtain materials such as the verification business license, the legal representative or the identity certificate of the person in charge online.
 
3. Publicize the approval procedures, acceptance conditions and handling standards, and publicly handle the progress.
 
4. Promote inter-departmental information sharing applications and strengthen post-event supervision.