Analysis of the relevant laws and regulations involved in the first penalty case for violating the new drug administration law

The Drug Administration Law, which entered into force on December 1, 2019, has a significant impact on the units engaged in the research, development, declaration, production, sale and use of pharmaceuticals in ChinaRecently, the Tianjin Municipal Market Regulatory Commission announced the thirty-fifth batch of typical cases of a case, more attention caused by the pharmaceutical industryThe specific situation is as follows: Tianjin Jinghai District Market Supervision Bureau according to the case clues to Yang a located in The Jinghai District of Tianjin, along the town of Chenda Road, the north side of the village mouth of the warehouse inspection, found that the warehouse stored Acapo sugar chips, Amoxicillin capsules and other 344 batches of drugs, the value of 401,000 yuanAfter investigation, Yang did not obtain a drug business license to engage in drug business activities, the Bureau took the above-mentioned drugs seized measuresThe conduct of the parties constitutes an illegal act referred to in Article 51 ( 1) of the Drug Administration Law of the People's Republic of China, and the Jinghai District Market Supervision Bureau has decided to impose an administrative penalty of 15 times the fine of 6015,000 yuan on Yang's confiscation of the drugs and goods involved in the case, and has transferred the case to the public security organsAlthough the above information is clear and complete, but in view of the new version of the Drug Administration Act came into effect in the country's first case of punishment in accordance with the new version of the Drug Administration Law standards, or the pharmaceutical industry concern and controversyThe author does not venture, for each reader combing the legal basis, analysis of the punishment logic, hope can helpThe new Version of the Drug Administration Act, which came into force on 1 December 2019, defines counterfeit and inferior medicines as follows: Article 98 prohibits the production (including formulation, the same), the sale, use of counterfeit drugs, and inferior medicinesIn one of the following cases, it shall be a counterfeit drug: (1) the ingredients contained in the drug are not in conformity with those prescribed by the national standards for drugs; (2) the drug is impersonated as a drug by a non-drug or by other drugs; (3) a drug that deteriorates; and (4) the indications or functional treatment indicated by the drug are out of the prescribed scopeIf one of the following circumstances is inferior: (1) the content of the pharmaceutical ingredients does not meet the national drug standards; (2) the contaminated drug; (3) the drug that does not indicate or change the validity period; (4) the drug that does not indicate or change the product batch number; (5) the drug that exceeds the validity period; (6) the drug that adds preservatives and accessories without authorization; and (7) other drugs that do not meet the drug standardsIt is prohibited to produce or import pharmaceutical drugs without obtaining the supporting documents for drug approval, and to prohibit the production of raw materials, packaging materials and containers that have not been reviewed and approved in accordance with the provisionsAnalysis: According to the above Tianjin official information, the parties Yang a violation of the law provisions, did not involve counterfeit drugs and bad drugs provisionsHowever, according to the above-mentioned official information content, the party Yang a warehouse used to store drugs should not be in the official record, the warehouse temperature and humidity and other conditions meet the GSP and drug standards indicated storage conditions, is also doubtfulIf warehouse management does not comply with GSP regulations, or obviously conflicts with the storage conditions specified in the drug standards, there are potential hazards for the quality of the drugThis risk may result in drugs being determined to be contaminated drugs covered by the definition of inferior drugs in the Drug Administration ActThe facts identified in the Tianjin official circular are that the conduct of the party, Yang, constitutes an illegal act referred to in Article 51 (1) of the Drug Administration Law of the People's Republic of ChinaTo verify the provisions of the new version of the Drug Administration Law, Article 51 reads: To engage in wholesale drug activities, a drug business license shall be obtained with the approval of the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government To engage in drug retailing activities, a drug business license shall be obtained with the approval of the drug supervision and administration department of the local people's government at or above the county level where it is located No drug shall be used without a drug business license The drug business license shall indicate the validity period and the scope of business, and the license shall be re-examined and issued at the expiration date The drug supervision and administration department shall, in addition to the conditions stipulated in Article 52 of this Law, follow the principle of facilitating the purchase of medicines by the masses Analysis: According to the above information, it can be determined that the party Yang a certain in the absence of a drug business license, on the illegal act of operating drugs is indisputable And once a citizen or legal person violates Article 51 above, the penalty standard is also clearly stated in the Drug Administration Law, that is, Article 115: If a drug production license, a drug business license or a medical institution's preparation license is produced or sold, he shall be ordered to close down, confiscate the illegally produced or sold drugs and illegal proceeds, and the value of the illegally produced and sold drugs (including the sold and unsold drugs, the same as the same as the same) shall be fined more than thirty times the value of the goods If the value of the goods is less than $100,000, it shall be calculated at 100,000 yuan Official information also confirmed this point: Yang made a confiscation of drugs involved in the case and the value of the goods 15 times the amount of a fine of 6015,000 yuan administrative penalties Many netizens after seeing the notice issued by the Tianjin Municipal Market Regulatory Commission above, the parties Yang a leased warehouse compliance is more concerned, the focus of discussion is whether the sales company can rent the warehouse In fact, the current regulations on this issue also clearly stipulate: Article 30, drug market license holders refer to the enterprises that have obtained a drug registration certificate or drug development institutions The holder of a drug listing license shall, in accordance with the provisions of this Law, be liable for non-clinical research, clinical trials, production and operation, post-marketing research, adverse reaction monitoring and reporting and treatment of pharmaceuticals Other units and individuals engaged in drug development, production, operation, storage, transportation and use shall bear corresponding responsibilities in accordance with the law The legal representative and principal person in charge of the drug market license holder are fully responsible for the quality of the drug Article 35 Where a drug market license holder, a pharmaceutical production enterprise or a pharmaceutical enterprise entrusts the storage or transportation of drugs, it shall evaluate the entrusted party's quality assurance and risk management capability, sign a entrustment agreement with it, agree on the duty of drug quality, operating procedures, etc., and supervise the trustee Analysis: From the above articles 30 and 35 can be seen, MAH can build their own warehouse, can also rent the warehouse However, whether it is self-built warehouse, or rented warehouse, it is necessary to meet the GMP, GSP requirements for drug storage conditions, and regulate management; The Measures for the Supervision and Administration of Drug Circulation (2007) are also the main regulations currently regulating the operation and circulation of pharmaceuticals, and in the revised document submitted in 2019, the topic has been revised to the Measures for the Administration of Drug Management Supervision and Management The Measures for the Supervision and Administration of Drug Circulation (2007) provide for the storage conditions as follows: Article 8 Pharmaceutical production and operation enterprises shall not store or sell medicines in stock at a place other than an address approved by the drug regulatory department Article 33 Any drug production or operation enterprise that stores drugs in a place other than an address approved by the drug supervision and administration department in violation of the provisions of Article 8 of these Measures shall be punished in accordance with the provisions of Article 74 of the Regulations on the Implementation of the Drug Administration Law Analysis: From the above regulations, the regulations clearly stipulate that drug business units must be at the officially approved address for drug storage, not in the non-officialapproval of the storage of drugs at the address If the storage space needs to be expanded for business reasons, the pharmaceutical business unit needs to file a new leased warehouse or a new warehouse for the record as required It is estimated that the party in this case Yang's warehouse did not complete the relevant record According to the Provisions of the Criminal Law of the People's Republic of China (as amended on November 4, 2017), the penalties for counterfeit and inferior drugs are as follows: Article 141 Anyone who produces or sells counterfeit drugs for the crime of producing or selling counterfeit drugs shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and shall be punished with a fine; and a fine or confiscation of property The term "fake drugs" as mentioned in this Article refers to drugs and non-drugs that are counterfeit and treated according to the provisions of the Drug Administration Law of the People's Republic of China Article 142 Anyone who produces or sells inferior drugs that cause serious harm to human health shall be sentenced to fixed-term imprisonment of not less than three years and not more than ten years, and a fine of not more than 50 percent of the amount of sales, or not more than 10 years of fixed-term imprisonment or life imprisonment, and a fine of not less than 50 percent or not more than two times the amount of sale or confiscation of property The term "bad medicine" as mentioned in this Article refers to a drug that is a bad drug in accordance with the provisions of the Drug Administration Law of the People's Republic of China Analysis: It should be said that although the above-mentioned criminal law law originally corresponded to the original version of the Drug Administration Law, but according to the text, after December 1, 2019, the above-mentioned criminal law law provides for automatic and current version of the Drug Administration Law In this case, the conduct of the party, Yang, was found by the Tianjin Municipal Market Supervision and Administration Commission to be a violation of the criminal law and has been handed over to the public security organs If investigated by the public security organs and prosecuted by the court, the final judgment should be based on the above-mentioned criminal law To sum up, although from the official notice, the party Yang is currently only found to have violated the provisions of Article 51 of the Drug Administration Law; Once again, the author reminds all the pharmaceutical industry colleagues, must comply with the operation, to avoid unnecessary risks.