According to the Shanghai Food and Drug Administration, recently, the Shanghai Huangpu District Market Supervision and Administration Bureau issued an administrative penalty to Novo Nordisk (China) Pharmaceutical Co., Ltd. Shanghai Branch. Novo Nordisk Shanghai Branch was fined 2606310 yuan and confiscated 102.9 yuan of illegal property for engaging in the third type of medical device business activities without permission.

According to the ticket, from January 2016 to October 2016, Novo Nordisk Shanghai Branch, in order to enhance the brand image of Novo Nordisk and enhance the popularity of brand-related products in the Shanghai market, without obtaining the Medical Device Business License, the Novo Nordisk salesperson applied for the quantity authority according to the needs, Apply for disposable sterile injection needle of Class III medical devices through the ONES system (produced by Novo Nordisk A/S, Denmark, import registration number: GSYJX (Jin) Zi 2013 No. 3150762, trade name: Novo needle, specification: 32G Tip ETW, hereinafter referred to as 32G Novo needle).

After the approval process is passed, Novo Nordisk (China) Pharmaceutical Co., Ltd. (hereinafter referred to as the head office) will send 32G Novo Nordisk needles to Room 3106, No. 3, Hongqiao Road, Xuhui District, Shanghai, according to the approved amount through third-party logistics, and the reception staff of the parties will sign the goods and distribute them to the regional managers of the parties, The regional manager will send the business personnel to carry the 32G Novo needles to the relevant departments or units designated by the medical institutions in Shanghai for free, and then the medical institutions will distribute them to the patients for use. The parties provided 35460 boxes of 32G Novo needles (7 pieces per box) to 133 medical institutions in Shanghai free of charge through the above methods. The company's internal settlement price of each box of 32G Novo needles was 4.9 yuan, which was finally included in the sales expenses of the head office, and the value of the goods was 173754 yuan. At the time of the case in October 2016, the party concerned had sent out 35460 boxes of 32G Novo needles. In November 2016, the party concerned stopped the business and recovered the 32G Novo needles that had not been distributed to patients from medical institutions, totaling 21 boxes.

To sum up, during the period from January 2016 to October 2016, without obtaining the Medical Device Business License, the party concerned operated disposable sterile injection needles for Class III medical devices in Room 3106, No. 3, Hongqiao Road, Xuhui District, Shanghai, with a quantity of 35460 boxes (7 pieces per box) and a value of 173754 yuan, and the recovered quantity after the case was 21 boxes. No illegal gains.

At present, Novo Nordisk Shanghai Branch has voluntarily fulfilled the penalty.