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

The Drug Administration Act, which came into effect on December 1, 2019, has a significant impact on the research, declaration, production, sale and use of pharmaceutical research and development in ChinaRecently, the Tianjin Municipal Market Supervision Committee announced the 35th batch of typical cases of a case, more attention of the pharmaceutical industryThe specific situation is as follows: Tianjin Jinghai District Market Supervision Bureau according to the case clues yang is located in the Jinghai District of Tianjin Along the town of Chenda Road, the north side of the east beach head village warehouse inspection, found that the warehouse stored Acapo sugar tablets, Amosilin 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 seizure measures for the above-mentioned drugsThe acts of the parties constitute the illegal acts 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 6015,000 yuan on Yang for confiscating the drugs and the value of the drugs involved 15 times the value of the drugs involved, and has transferred the case to the public security organsAlthough the above information is clear and complete, but in view of this is the new version of the Drug Administration Law came into force after the country's first case of punishment based on the new version of the Drug Administration Law standards, or by the pharmaceutical industry concern and controversyThe author does not venture, for all readers comb the legal basis, analysis of the punishment logic, I hope can helpDiscussion Point 1 - Analysis of the definition of counterfeit and inferior drugs listed in the new Drug Administration Act
which came into effect on 1 December 2019, defines counterfeit drugs and inferior drugs as follows: Article 98 prohibits the production (including preparation, the same), sale, use of counterfeit drugs, and inferior drugs, the drug shall be a counterfeit drug if it is: (1) the content of the drug does not conform to the ingredients prescribed by the National Drug Standard; (2) the drug is impersonated as a drug with a non-drug or the drug of other kinds of medicine, (3) the drug is degraded; and (4) the indicationor or functional treatment indicated by the drug is beyond the prescribed scope, if there are any of the following circumstances, it is a bad drug: (1) the content of the pharmaceutical ingredients does not meet the national drug standards; (2) the contaminated drugs; (3) the drugs that have not marked or changed the validity period; (4) the drugs that have not indicated or changed the batch number of the product; (5) the drugs that exceed the expiration date; (6) the drugs that add preservatives and accessories without authorization; and (7) other drugs that do not meet the drug standardsprohibitthe production and import of drugs without obtaining proof of approval of drugs, and prohibit the production of pharmaceutical sass, packaging materials and containers that have not been reviewed and approved in accordance with the provisionsanalysis: According to the above Tianjin official notification information, the party Yang's behavior violated the provisions of the law, there is no provisions involving counterfeit drugs and inferior drugsBut according to the above-mentioned official communication, the party Yang a warehouse used to store drugs should not be in the official record, the warehouse temperature and humidity and other conditions to meet the GSP and drug standards indicated storage conditions, is also doubtfulIf warehouse management does not comply with GSP specifications, or if there is a clear conflict with the storage conditions indicated in the drug standards, there are potential hazards for the quality of the drugThis risk could result in drugs being determined to be contaminated (ii) those covered by the definition of inferior drugs in the Drug Administration ActPoint 2 - The legal basis for the punishment of the parties in this case is based on the the facts mentioned in the Tianjin official circular as: The act of the party yang constitutes the illegal act referred to in Article 51 (1) of the Drug Administration Law of the People's Republic of China To 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 If there is no license for the operation of drugs, no drugs may be operated The drug business license shall indicate the validity period and scope of operation, and the license shall be re-examined at the expiration date In addition to the conditions stipulated in Article 52 of this Law, the drug regulatory department shall follow the principle of facilitating the purchase of medicines by the masses, in addition to the conditions stipulated in Article 52 of this Law analysis: According to the above information, it can be determined that the party Yang a drug business license without a license, the illegal act of operating drugs is beyond doubt 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: the production and sale of drugs without obtaining a drug production license, a drug business license or a medical institution preparation license Ordered to close down, confiscate the illegal production and sale of drugs and illegal income, and punish the illegal production and sale of drugs (including sold and unsold drugs, the same below) the value of the value of more than fifteen times 30 times; The official circular also confirmed this: Yang was fined 6015,000 yuan for confiscating the drugs and the value of the drugs involved 15 times Discussion point 3 - sales link warehouse condition management requirements
many netizens in the above Tianjin Municipal Market Supervision Committee issued a notice, for the party Yang a leased warehouse compliance situation is more concerned, the focus of the discussion is whether the sales company can rent the warehouse In fact, the current regulations on this issue also clearly defined: 3.1 - the new version of the Drug Administration Law provides Article 30 drug market licensing holders refer to the enterprises that have obtained a certificate of registration of drugs 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 studies, clinical trials, production and operation, post-market research, monitoring and reporting of adverse reactions Other units and individuals engaged in drug research, production, operation, storage, transportation, use and other activities shall bear corresponding responsibilities in accordance with the law The legal representative and principal person in charge of the drug market ingress license holder shall be fully responsible for the quality of the drug Article 35 Where the holder of a drug listing license, a pharmaceutical production enterprise or a pharmaceutical business enterprise entrusts the storage and transportation of drugs, it shall evaluate the quality assurance ability and risk management ability of the entrusted party, sign a entrustment agreement with it, agree on the responsibility 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 warehouse But whether it is self-built warehouse, or rental warehouse, need to meet the GMP, GSP on drug storage conditions, and regulate management; 3.2- The Measures for the Supervision and Administration of Drug Circulation provide for the resolution of the the Measures for the Supervision and Administration of Drug Circulation (2007) or the main regulations currently governing the operation and circulation of pharmaceutical drugs; The Measures for the Supervision and Administration of Drug Circulation (2007) provide for the storage conditions as follows: article 8 of the pharmaceutical production and operation enterprises shall not store or sell drugs in stock places other than addresses approved by the drug regulatory department Article 33 If an enterprise for the production and operation of a drug, in violation of the provisions of Article 8 of these Measures, stores drugs in a place other than an address approved by the drug regulatory department 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 to store drugs at an address not approved by the official If for operational reasons, it is necessary to expand storage space, drug business units need to be required to new leased warehouses or new warehouses for the record It is estimated that the warehouse of Yang, the party involved in the case, has not completed the relevant filing Discussion Point 4 - The Resolution of the Provisions of the Chinese Criminal Law on Counterfeit drugs and Bad Drugs
In accordance with the provisions of the Criminal Law of the People's Republic of China (revised on November 4, 2017), the penalties for counterfeit drugs and inferior drugs are as follows: article 141 of the production and sale of counterfeit drugs Where a drug is not enough to be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and shall be fined; if he causes serious harm to human health or other serious circumstances, he shall be sentenced to fixed-term imprisonment of not less than three years and not more than ten years, and shall be fined; if he causes death or other particularly serious circumstances, he shall be sentenced to fixed-term imprisonment of not less than ten years, life imprisonment or death penalty, and shall be punished with a fine or confiscation of property The term "counterfeit medicine" as mentioned in this Article refers to drugs and non-drugs that are counterfeit and treated according to counterfeit drugs in accordance with the provisions of the Drug Administration Law of the People's Republic of China Article 142, The production and sale of inferior drugs, which 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 the amount of sales shall be punishable by a fine of not more than 50 percent or not more than two times the amount of sales; The term "bad medicine" as mentioned in this Article refers to a drug that is inferior 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 is originally corresponding to the original version of the Drug Administration Law, but according to the text, after December 1, 2019, the above-mentioned criminal law provides that automaticand and the current latest version of the Drug Administration Law docking In this case, the behavior of the party Yang, was recognized by the Tianjin Municipal Market Supervision and Administration Commission as violating the criminal law, 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 The conclusion , although from the official notification, the party Yang is currently only found to have violated Article 51 of the Drug Administration Law; Again, the author reminds your colleagues in the pharmaceutical industry, we must comply with the operation, to avoid unnecessary risks