Release date: 2007-07-11 Hospital: How to deal with cases in which medical institutions' preparations flow into the market. A, B, C, and D are all legal units. A hospital has obtained the "medical institution preparation license", and its preparation preparation ephedrine nasal drops also obtained the approval number of the preparation, but the hospital A will sell the ephedrine nasal drops to the medicine company B, and the medicine company will drop the ephedrine. Nasal fluid was sold to C-pharmaceutical company, and C-pharmaceutical company sold ephedrine nasal drops to Ding Hospital. A Plant Extract is a substance or an active with desirable properties that is removed from the tissue of a plant, usually by treating it with a solvent, to be used for a particular purpose. The form of the herbal extracts uaually are the powder. The color depends on the raw matrials herb. Plant Extract,Herbal Extract,Diosmin Extract Powder,Hesperidin Extract Powder Drotrong Chinese Herb Medicines Co.,Ltd. , https://www.drotrongherb.com
Discussion Medical institution preparation refers to a pharmaceutical preparation that meets the quality standards prepared by a medical institution according to the clinical and scientific research needs of the unit and in accordance with the prescribed pharmaceutical production process rules.
The preparations prepared by the medical institution are generally the empirical or agreed prescriptions that the medical institution has summarized in the long-term medical practice, and are preparations that are confidential or patent-pending. It did not carry out experiments on pharmacology, efficacy, toxicology, biological agents, etc. in accordance with the provisions of the "New Drug Approval Measures", nor did it approve the listing after review by experts in accordance with the prescribed procedures, and there is no perfect scientific experiment that is normative demonstration. The data proves its safety and effectiveness. The preparation of preparations by medical institutions is generally formulated according to clinical needs, and has the characteristics of poor stability, immature process and short effective period. Therefore, it can only reduce the circulation period, and can only be used as a prescription drug in the medical institution, and cannot expand the scope of use.
Therefore, the state has very strict regulations on the preparations prepared by medical institutions: the preparations prepared by medical institutions shall be the varieties that are not in the market for clinical needs of the unit, and must be subject to the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government. Formulated after approval, and prescribed by the physician in the medical institution.
It can be seen from this case that when ephedrine nasal drops enter the market, the following three situations will occur:
The medical institution sells its formulated preparations on the market. A hospital sells ephedrine nasal drops to the company B. In essence, the hospital preparations are circulated in the market. Sales is a kind of social relationship in which the price of goods is used as a medium, that is, a social activity aimed at obtaining the corresponding price by transferring the ownership of goods. “Marketing in the market†means that the preparations prepared by the medical institution are not distributed to the patients by the pharmaceutical department according to the doctor's prescription of the medical institution or are approved for use in other medical institutions according to the provisions of this article, but are otherwise distributed to the medical institution. Sold or used outside of the country, including patients ordering drugs via the Internet.
Obviously, the hospital A has violated the provisions of Article 25, paragraph 2, of the Drug Administration Law, “The preparations prepared by medical institutions shall not be sold in the marketâ€.
Therefore, as long as the food and drug supervision department has mastered the evidence that A hospital sells ephedrine nasal drops on the market, it can impose penalties on hospital A according to the provisions of Article 84 of the Drug Administration Law: “Medical institutions will If the formulated preparations are sold on the market, they shall be ordered to make corrections, the illegally sold preparations shall be confiscated, and a fine of more than one time and three times the value of the illegally sold preparations shall be imposed; if there is illegal income, the illegal income shall be confiscated."
Medical institutions use the preparations prepared by other medical institutions without authorization. In the above cases, it is illegal for Ding Hospital to use the formulated preparation of ephedrine nasal drops from hospital A. Because the preparations prepared by medical institutions lack complete scientific experiments to prove their safety and effectiveness, and the doctor's diagnosis of the patient's condition and the dosage of the preparation will affect the efficacy and even affect the patient's life safety, it is not suitable to expand the preparation. The scope of use in other hospitals. Ding Hospital has not used the ephedrine nasal drops without the approval of the food and drug regulatory authorities. It has violated the provisions of the first paragraph of Article 25 of the Drug Administration Law: “The preparations prepared by medical institutions should be the clinical needs of the unit. The varieties that are not available in the market must be approved by the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government. The prepared preparations must be inspected according to the regulations; if they are qualified, they should be used in the medical institution with the prescription of the doctor. Under special circumstances, the preparations formulated by medical institutions may be transferred between designated medical institutions after approval by the State Council or the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government."
Therefore, Ding Hospital should also be subject to administrative penalties, according to Article 66 of the Regulations on the Implementation of the Drug Administration Law and Article 80 of the Drug Administration Law: “Confiscation of illegally purchased drugs and illegal purchases If the amount of the drug is less than two times and less than five times the fine, if there is illegal income, the illegal income shall be confiscated. If the circumstances are serious, the medical institution's practice license shall be revoked."
Drug business enterprises sell pharmaceutical preparations prepared by medical institutions. Drug business enterprises must sell hospital preparations when they want to sell the preparations prepared by medical institutions. There are two situations here: First, these preparations are purchased directly by the pharmaceutical business enterprise from the hospitals that prepare the preparations. For example, in the above case, the pharmaceutical company belongs to this situation; the second is that these preparations are purchased by the pharmaceutical business enterprises from the pharmaceutical wholesale enterprises. In the case of the above case, the case of C Pharmaceutical is the case.
In the case of penalties for the first case, some people may think that the preparation of the preparations prepared by the B-pharmaceutical company violates Article 16 of the Measures for the Administration of Drug Distribution and Supervision (Order No. 26), and Article 37 should be used. Punishment. However, careful analysis of the behavior of B pharmaceutical companies, the author believes that B pharmaceutical companies should be qualitatively purchased from illegal sources. Because the hospital did not obtain the permission to sell the preparations on the market, and the hospital did not qualify for the production or wholesale of medicines, that is to say, the medicine company B purchased the medicines from the units that did not have the qualification for the production and operation of the medicines. Therefore, B Pharmaceutical Company violated the provisions of Article 34 of the Drug Administration Law: "Pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and medical institutions must purchase medicines from enterprises that have the qualifications for drug production and operation; however, purchases have not been implemented. Except for Chinese Herbal Medicines approved for document number management."
We know that the Drug Administration Law is a law formulated by the National People's Congress, and the Measures for the Supervision and Administration of Drug Distribution is a departmental regulation issued by the State Food and Drug Administration. Based on the principle that the superior law is superior to the lower law, it is obvious that drug management The legal effect of the Law is higher than the "Measures for the Supervision and Administration of Drug Distribution". The upper-level law should be applied to the application of the upper-level law, although the punishment content of Article 37 of the Measures for the Administration of Drug Circulation Supervision is ultimately based on the Drug Administration Law. Article 80, that is, the final punishment is the same. In this case, the “Measures for the Administration of Drug Distribution Supervision†cannot be applied, because it will involve the question of whether the case is accurate and whether the laws and regulations are accurate. Therefore, the author believes that Article 68 of the Drug Administration Law is applicable to the punishment of the B Pharmaceutical Company: “The pharmaceutical production enterprise, business enterprise or medical institution violates the provisions of Article 34 of this Law and has no “Pharmaceutical Production Licenseâ€. If the enterprise of the "Pharmaceutical Business License" purchases drugs, it shall be ordered to make corrections, confiscate the illegally purchased drugs, and impose a fine of not more than two times and five times the value of the drug purchased illegally; if there is illegal income, the illegal income shall be confiscated. If the circumstances are serious, the "Pharmaceutical Production License", the "Pharmaceutical Business License" or the medical institution's practice license shall be revoked."
For the punishment of the second case, the author believes that the channel for the purchase of the preparations prepared by the medical institution by the pharmaceutical company is legal. B pharmaceutical company is a legal wholesale pharmaceutical business, but the regulations stipulate that pharmaceutical companies cannot purchase hospital preparations. Therefore, C Medical Company violated Article 16 of the Measures for the Supervision and Administration of Drug Distribution and should be punished in accordance with Article 37. (Sohu)