Medical network - on April 10, 2017 on April 7, state drug administration website about the implementation of "the state council the third batch of cancel the designated place to implement the decision of the administrative licensing item" about the work (hereinafter referred to as the "notice"). 

 

The drug regulatory department at the provincial level for lifted the Internet for examination and approval of pharmaceutical trading service enterprise (except for the third party platform). This is not only the combination of the pipes, also means that the Internet drugstore sell drugs be approved, completely online pharmacies sell drugs without examination and approval, can be directly according to the demand for network medicine (example application taobao pharmacies, WeChat pharmacy, etc.). From the implementation of the cancelled network medicine examination and approval decision is enough to prove that the countries to speed up the pace of medicine online. 

 

▍ medicine online, B, C certificate completely gone 

 

In the past, the pharmaceutical trade license points three Internet card, card for A and B, C. 

 

A certificate (national level), it is the Internet company, is A medicine of B2B platform, platform with buyers and sellers. A card platform commissions on both sides of the transaction. 

 

B card (provincial), itself if pharmaceutical wholesale company, is the seller, drugs provide drugs wholesale services via the Internet. Medicine is a B2B platform, a seller, many buyers, mainly through the product profit making money. 

 

C card (application) at the provincial level, is itself a chain drugstore. To individual consumers in online retail drug, is the B2C platform, the main product profit earned money. 

 

Except as stipulated in the "notice" the third party platform, so A card is still there. 

 

▍ sales drug's door has been opened 

 

Online sell drugs for pharmaceutical retail enterprises, a "notice", "pharmaceutical retail chain enterprises can provide the Internet drug transaction services to individual consumers, but shall not exceed the scope of business of the pharmaceutical trade license, may not be sold on the website trading relevant page display, prescription drugs and over-the-counter medicines management requirements of the country has a special." 

 

At the same time, the provincial supervision department on the implementation of the Internet for examination and approval of pharmaceutical trading service enterprises have been cancelled. For this rule to cancel, is not only a recognition of net selling drugs, is also an expression of the cull to delegate. For companies, convenient retail pharmacies open the doors of the net selling drugs, and provide better service for more patients. 

 

▍ drug companies can't direct sales, pharmacy to be protected 

 

At the same time, the "notice" clearly stipulates, "the pharmaceutical producing enterprises, pharmaceutical wholesale enterprises can through its web site and other enterprises to carry out Internet drug deal, but not to provide Internet drug transaction services to individual consumers." 

 

Throughout the Internet retail industry, manufacturers direct docking individuals often will affect industry unit sales. Now require drug companies can't direct docking individuals, it is not only the protection of consumers, and the protection of individual retail pharmacies. Organic integration the offline resources not only so, at the same time also expanded industry sales. 

 

▍ medicine online, competitiveness lies in the user 

 

Chinese medicine materials association deputy secretary-general WeiShaoFeng to pharmacy managers said that as of March 28 this year, the national 678 online pharmacies. With the cancellation of the administrative examination and approval, the chain drug stores to open online pharmacies, don't have to go to the approval and for the record. As to whether monomer drugstores can open online pharmacies, according to the previous regulations, is not possible. This through, there was no mention of it was implemented according to the old rules and regulations, means that can't. 

 

One, he said, before online pharmacies licences can be worth 56 million, from now on will be worthless after the, in the future competition is the user's competition, the user has to the world. 

 

Attached: the original 

 

Office of administration on the implementation of "the state council the third batch of cancel the designated place to implement the decision of the administrative licensing item" about the work 

 

Provinces, autonomous regions and municipalities directly under the food and drug administration, the xinjiang production and construction corps food and drug administration: 

 

On January 21, 2017, the state council issued "the third batch of cancel the designated place to implement the decision of the administrative licensing items" (guo fa [2017] no. 7), was canceled by the provincial food and drug regulator on the implementation of pharmaceutical excipients (excluding drugs with auxiliary materials and import of medicinal materials) to register for examination and approval, drug clinical trial institution qualification first trial, the Internet for examination and approval of pharmaceutical trading service enterprises (except for the third party platform) three administrative licensing matters. In order to implement the cancel the requirements of the relevant administrative licensing items, the good afterwards regulatory measures to carry out the work and cohesion, and regarding the notify is as follows: 

 

One, the provincial food and drug regulators about lifted pharmaceutical excipients (excluding drugs with auxiliary materials and import of medicinal materials) to register for examination and approval 

 

Provincial food and drug regulatory departments shall, in accordance with the pharmaceutical excipients on the medicine packaging material for examination and approval of relevant matters associated with drug evaluation of announcement no. 134 (2016), the implementation of the pharmaceutical excipients associated review for examination and approval work, completes the domestic risky pharmaceutical excipients on-site inspection, sampling, etc. We need to strengthen the daily supervision of medicinal materials production enterprises, strengthen the extension of pharmaceutical excipients check, ensure the quality of medicines. 

 

Second, the provincial food and drug regulators about lifted the drug clinical trial institution qualification of first trial 

 

Drug clinical trial institution qualification and check check by the food and drug supervision administration (hereinafter referred to as the bureau) to accept, do not need to submit application materials in the health administrative department at the provincial level and provincial food and drug regulatory audit opinion. Applicant respectively in administration of drug clinical trial institution qualification reviewing electronic application system and inspection system, fill in application form as required and the application materials, paper data sent to the administration of verification center, general administration of form will notify the applicant in writing after the review whether to accept. Site inspection and audit results will inform the applicant in writing, the general administration for an announcement by recognition of the qualifications of the applicant and issue the certificate. 

 

Three, the drug regulatory department at the provincial level about lifted the Internet for examination and approval of pharmaceutical trading service enterprises (except for the third party platform) 

 

(a) about the Internet drug trade 

 

Has made the Internet drug trading services qualification of the enterprise, should be in strict accordance with the drug supply quality management regulations and the relevant documents requirements is engaged in the Internet and drug transaction services, strengthen the system of storage, distribution and so on, to carry out the management responsibility, guarantee the quality of the medicines are sold. 

 

1, pharmaceutical producing enterprises, pharmaceutical wholesale enterprises can communicate with other enterprises through its own website Internet drug deal, but not to provide Internet drug transaction services to individual consumers. 

 

2, pharmaceutical retail chain enterprises can provide the Internet drug transaction services to individual consumers, but shall not exceed the scope of business of the pharmaceutical trade license, may not be sold on the website trading relevant page display, prescription drugs and the country has a special management requirements of over-the-counter medicines. 

 

The Internet drug transaction services regulatory policy will be issued separately. 

 

(2) medical device trading on the Internet 

 

Engaged in the Internet trading service of medical equipment enterprises, shall obtain the business license in accordance with the law or for the record, and engaged in business activities in accordance with the scope of the license or registration, and in a timely manner to an enterprise name, domicile, legal representative, address and medical equipment business license or registration certificate number information such as notify the local districts municipal food and drug supervision and administration department. 

 

1. The medical device production enterprise can through their own web site provides the enterprise in the production of medical apparatus and instruments online trading services. 

 

2. Medical equipment wholesale enterprise may use its website to medical apparatus and instruments with qualification for the enterprise or the use of units to provide the Internet trading service of medical equipment, but not to provide medical device trading services for consumers. 

 

3. Medical equipment retail enterprises can through its own website to provide Internet medical device trading services to individual consumers, but its sales of medical equipment shall not exceed the medical equipment business license or the second category of the business scope of the business registration certificate of medical equipment. 

 

4. Personal retail medical equipment to consumers, should be can be used by individual consumers themselves, the specification shall meet the medical instrument instruction manual and the regulations on the label the provisions of article 10 of the first item (8), special instructions for the safe use of annotations. 

 

Internet medical device trading services regulatory policy will be issued separately. 

 

(3) the supervision requirements 

 

The food and drug supervision departments at all levels should continue to do a good job in the Internet trade supervision, medicine and medical instrument standard Internet drug trading main body and behavior, take effective measures of supervision and crack down on Internet illegal sale of drugs, medical devices, etc. 

 

Fourth, cohesive work demands 

 

Provincial food and drug regulators should take to do a good job of implement and cohesion cancel the administrative licensing items, the decision to cancel the administrative licensing matters, since "the state council about the third batch of cancel the designated place to implement the decision of the administrative licensing items" (guo fa [2017] no. 7) the date of release, provincial food and drug regulators no longer accept the cancellation of administrative licensing items of application; Release, ShengJu has accepted that the cut-off issue has not been completed from the date of approval, should terminate the examination and approval, and return the application materials to the applicant. Original licensing department licensing or other calling for examination and approval shall not be made, at the same time to strengthen the regulation of things after the event, and to combine the pipes. 

 

The food and drug supervision administration office 

 

On April 6, 2017