Internet drug business license application process

Internet drug business license

Application process

Internet drug business license

Application process

Internet drug information services are divided into two categories: commercial and non-commercial.。Commercial Internet drug information services refer to activities that provide paid drug information and other services to Internet users through the Internet.。Non-commercial Internet drug information services refer to the free provision of public information to Internet users through the Internet.、Activities to share drug information and other services。

Commercial Internet drug information services refer to activities that provide paid drug information and other services to Internet users through the Internet.。Non-commercial Internet drug information services refer to the free provision of public information to Internet users through the Internet.、Activities to share drug information and other services。

Website intended to provide Internet drug information services，It should be done before applying for a business license or going through the filing procedures with the information industry department of the State Council or the provincial telecommunications management agency.，In accordance with the principles of territorial supervision and management，To the province where the website sponsor is located、autonomous region、The municipal (food) and drug supervision and administration department submits an application，Obtain the qualification to provide Internet drug information services after review and approval。

Application conditions

：Apply to provide Internet drug information services，In addition to complying with the provisions of the "Internet Information Services Management Measures"

Require

outside，The following conditions should also be met：(1) Providers of Internet drug information services should be enterprises, institutions or other organizations established in accordance with the law.；(2) Have professionals suitable for carrying out Internet drug information service activities、Facilities and related systems；(3) There are two or more people familiar with the drug、Medical device management laws、Regulations and Drugs、Medical device expertise，or a pharmacy that has been qualified in accordance with the law、Medical device technician。

1、Cooperate with service providers with experience in building pharmaceutical e-commerce platforms (faster efficiency，The system is more mature)，Or develop your own e-commerce platform that provides online transaction services (longer time period)，Commonly known as "online shopping mall"。2、The platform system，Submit it to a software evaluation center institution with relevant evaluation capabilities and authorization specified by the State Food and Drug Administration for evaluation.。

The specific content of the evaluation includes the following points:：a)Chinese characteristics of software platform、Ease of use、security、stability、efficiency、security documentation、Use documentation、Development documents, etc.。b)The evaluation period will probably be completed around 2。c)Evaluation completed，The evaluation center submits a software evaluation pass report。

3、Enterprises based on the evaluation report provided by the evaluation center，and related application documents、Manage documents、Organizational documents、After-sales documentation、Service documentation、Rights protection documents, etc.，Submit it to the local Provincial Food and Drug Administration for on-site acceptance。4、The Provincial Food and Drug Administration arranges specialists to conduct on-site inspections at the company’s e-commerce operation center、ask、Acceptance work，If on-site acceptance is completed，Provide drug transaction services license in approximately 30 working days。

illustrate：throughout the process，A lot of documentation needs to be prepared、Software systems must be evaluated according to

Require

Carry out design and development，And on-site acceptance requires corresponding operating conditions.、Manpower composition、Medical specialist, etc.，And the system needs to be hosted in IDC computer room as much as possible，Purchase appropriate security equipment and software。

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