Vol.2, No.23

CHINA LEX PHARMA LAW NEWSLETTER

Vol. 2 , No.23 - September 11, 2001

TOPICS THIS ISSUE:

• Drug Reps Go Too Far for Nanjing Hospital
• Circular On Drug Toll Manufacturing
• Approved GMP List

Drug Reps Go Too Far for Nanjing Hospital

In their enthusiastic promotion of products, drug company representatives have been accompanying doctors at work and even helping doctors to write prescriptions. Such strange sales techniques have been going on in many hospitals in Nanjing. Recently, Nanjing Gulou Hospital contacted their 128 drug distributors and prohibited them from practicing over-zealous activities.

Although Nanjing Gulou Hospital has entered into Drug Purchase Contracts with many drug distributors, there are still drug reps promoting their products in clinics and emergency rooms. Many patients have been complaining that the presence of the drug reps disturbs the normal order and working environment of the hospital.

Gulou Hospital requested the 128 drug distributors to strictly abide by the Drug Purchase Contract they signed with the hospital. The hospital also prohibited promotion activities in any form, such as commissions based on promotion, advertising commissions and free sample drugs. Furthermore, drug reps are not allowed to promote their products in any area of diagnosis or treatment, including the emergency room and hospital entrances. The hospital also warned that accompanying doctors at work and helping them write prescriptions is also forbidden. Gulou Hospital said that if drug distributors continue in disallowed sales practices, such as promotion inside the hospital or giving prohibited commissions to doctors, their purchase contracts will be cancelled.

(Source: Yanzi Evening Newspaper)

 

Circular On Drug Toll Manufacturing

(Issued by State Drug Administration, October 8, 1999)

China's regulation on toll manufacturing was issued in 1999, but very little activity ensued as a result. Recently, the SDA has suggested that the option of toll manufacturing is now a reality. Because several of our readers have contacted us regarding this legislation, we have included the English translation of the regulation in this week's newsletter.

1. Off-site drug manufacturing refers to a drug manufacturer that produces drugs, with the same approval number, in more than one facility. By doing so, the manufacturer can adjust its internal product structure and help increase the quantity of its products. Toll manufacturing refers to the process by which enterprises that own approvals for drugs entrust other drug manufacturing enterprises to manufacture the drugs for them. Both off-site drug manufacturing and toll manufacturing must be approved by the State Drug Administration.

2. Pharmaceutical raw materials, blood products and vaccines are not allowed to be manufactured through off-site manufacturing or toll manufacturing. Off-site manufacturing and toll manufacturing of other special drugs shall be managed according to related regulations of the State.

3. The quality, ingredients, manufacturing technology, packaging, label, instruction and approval number of the drugs shall be maintained as identical with those of the original drugs. For the packaging and labeling of the off-site manufacturing drug, the incorporation name, manufacturing unit and location shall be stated clearly. For the packaging and labeling of toll-manufacturing drug, the names of the two parties and the processing place shall be stated clearly. The toll manufacturing drugs shall be sold by the licensor.

Legal liability for the drugs manufactured by off-site manufacturing or toll manufacturing shall be undertaken by the owner of the approval number.

4. Enterprises that accept off-site manufacturing and toll manufacturing projects shall be the legal entities that hold a pharmaceutical manufacturing license and GMP Certificate.

5. The two parties of the toll manufacturing relationship shall reach a toll manufacturing contract to regulate respective obligations according to the regulations of the drug administration. Such contracts must be notarized.

6. The application materials for off-site manufacturing and toll manufacturing include:

(1)copies of the licenses of the two parties;

(2)copies of GMP certificates of those processing enterprises or workshops;

(3)copies of the drug manufacturing approvals, quality criteria, labels and packaging of the original drug, instructions;

(4)the proposed packaging of the drug, label, instruction of the processing enterprises or workshops;

(5)the corporate documents of the drug manufacturers, and a copy of the notarized toll manufacturing contract;

7. Enterprises that conduct off-site manufacturing and toll manufacturing without approval will be considered the same as enterprises without approval numbers. The manufactured drugs will be deemed as fake drugs.

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(continued from last week)

Name of Enterprises	Certified Scope
50. Guizhou Lindong Pharmaceutical Factory	High Dose Injection
51. Guizhou Kaili Pharm. Co., Ltd	High dose Injection
52. Nanjing Chang-Ao Pharm. Co., Ltd	Capsule (Penicillinum), Tablet, Freezing-drying Powder-Injection, Ointment, Jellies
53. Nanjing Chang-Ao Pharm. Co., Ltd	Powder-Injection (Cephalosporin)
54. Harbin Shenqi Pharmaceutical Co., Ltd	Powder-Injection (Cephalosporin)
55. Zhengjiang Hansheng Pharm. Co., Ltd	Recombination Human Interferon a2b Production Workshop
56. Shanghai Yanan Wanxiang Pharmaceutical Co., Ltd	Soft Gelatin Capsule
57. Zhengjiang Hars Biochemistry Pharm. Co., Ltd	Tablet, Capsule
58. Hangzhou Aida Pharmaceutical Co., Ltd	High Dose Injection
59. Tianjin Xingfeng Pharm. Co., Ltd	Powder-Injection (Cephalosporin), Tablet, Capsule
60. Ningbo Zhengda Pharmaceutical Co., Ltd	High Dose Injection
61. Huai Nan Fushou Pharmaceutical Co., Ltd	Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor for Injection Workshop, Ointment (Hormone)
62. Beijing Tsinghua Unisplendour Pharm. Factory	Powder-Injection (Penicillinum, Cephalosporin), Tablet, Capsule, Ointment
63. Dan Dong Pharmaceutical Factory	Freeze-drying Powder-Injection
64. Inner Mongolia Daban Pharm. Factory	High Dose Injection
65. Shenyang Tianling Pharmaceutical Co., Ltd	Tablet, Capsule, Granule
66. Hunan Galaxy Bitech Co., Ltd	Freeze-drying Powder-Injection (Antineoplastics)
67. Guangxi Beihai Pharmaceutical Factory	Freeze-drying Powder-Injection
68. Shineway Pharmaceutical Co., Ltd	High Dose Injection, Low Dose Injection
69. Anhui Quan Xing Pharm. Co., Ltd	Powder-Injection (Cephalosporin)
70. Bethune Medical University Pharm. Factory	Freeze-drying Powder-Injection
71. Zhejiang Kinisy Pharmaceutical Co., Ltd	Tablet, Capsule
72. Gansu Jiulong Pharmaceutical Factory	High Dose Injection
73. Hainan Asia Medicine Co., Ltd	Tablet, Capsule, Granule
74. Zhejiang Dier Pharm. Co., Ltd	Tablet, Capsule, Granule, Syrups, Solution
75. Zhejiang Yafeng Pharmaceutical Factory	Capsule, Granule
76. Zhejiang Jinhua 3rd Pharm. Factory	Tablet, Capsule, Granule
77. Zhejiang Fangqiang Pharmaceutical Factory	Tablet, Capsule, Granule
78. Shanghai AJINOMOTO Amino Acid Co., Ltd	Raw Materials
79. Shenzhen Aventis Pasteur Biological Products Co., Ltd	Influenza Virus Kill Vaccine Package Workshop
80. Weihai Aiwei Pharmaceutical Co., Ltd	High Dose Injection
81. Hainan Star Pharmaceutical Co., Ltd	Powder-Injection (Cephalosporin), Freeze-drying Powder-Injection, Low Dose Injection
82. Luoyang Qinling Pharm. Factory	High Dose Injection
83. Shanxi Linfen Yunpeng Pharmaceutical Co., Ltd	High Dose Injection
84. Zhongqing Sainuo Bio-Pharmaceutical Co., Ltd	Tablet, Capsule, Granule
85. Harbin Pharmaceutical Group Holding Co., Ltd	Tablet (Cephalosporin), Capsule, Granule, (Cephalosporin & Penicillinum)
86. Qingdao Guoda Bio-Pharmaceutical Co., Ltd	Recombinant Streptokinase Workshop
87. Shandong Wuhu Luye Pharmaceutical Co., Ltd	Tablet, Capsule, Granule
88. Zhengda QingChunBao (HeGang) Pharm. Co., Ltd	Tablet, Capsule
89. Yangzhou Zhongbao Pharmaceutical Co., Ltd	High Dose Injection
90. Weifang Zhongshi Pharmaceutical Co., Ltd	Tablet
91. Qingdao Haier 3rd Pharmaceutical Factory	Freeze-drying Powder-Injection
92. Shenyang Enshi Pharmaceutical Co., Ltd	Capsule (Cephalosporin), Tablet, Granule
93. Huainan 3rd Pharmaceutical Factory	High Dose Injection
94 Shanghai Blood Center	Blood Shape-definition Agent
95. Shanxi Tongzhen Pharmaceutical Co., Ltd	Powder-injection (Penicillin)
96. Datong 2nd Pharmaceutical Factory	Powder-Injection (Penicillin)
97. Beijing Yuance Pharmaceutical Co., Ltd	Recombinant Human Interferon a2b
98. Ningbo Renjian Pharmaceutical Co., Ltd	Bulk Drug, Freeze-Injection
99. Zhejiang Tianfeng Pharmaceutical Factory	High Dose Injection
100. Jiangsu Suzhong Pharmaceutical Factory	High Dose Injection

 

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Lehman Lee & Xu

China Lawyers, Notaries, Patent, Copyright and Trademark Agents

http://www.chinalaw.cc/

Beijing Office	Shanghai Office
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