State Drug Administration: two drugs are out of sale nationwide.

On 16 September, the State Drug Administration issued the Notice on the Suspension of the Import, Sale and Use of POLICHEM S.R.L. Nitrothel tablets and Nitrothel vaginal tablets (hereinafter referred to as the Bulletin).
(Photo source: Intercepted to the State Drug Administration) "Announcement" pointed out that the State Drug Administration recently organized the POLICHEM S.R.L. nitroseril tablets and nitroseril vaginal tablets to carry out drug overseas production site inspection.
After investigation, nitrothyl tablet products exist in the enterprise failed to submit rectification plan and carry out effective rectification of defects found in accordance with the requirements of the inspection, nitroseril vaginal tablet products have the actual process and declaration process is not completely consistent, affecting the key quality attributes of the product and other problems.
does not meet the requirements of China's Drug Production Quality Management Code (revised in 2010).
In accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China, the State Drug Administration has decided to suspend the import, sale and use of POLICHEM S.R.L. nitroseril tablets and nitroseril vaginal tablets from now on.
the drug regulatory departments at the ports where the above-mentioned products are issued.
two drugs, mainly used in gynaecological diseases according to the Notice of the State Drug Administration, Nifuratel tablets in English: Nifuratel Tablets;
the drug is used for bacterial vasculitis, thyroid vasculitis, white mycobacteria in the vulva vagina, urinary system infections, digestive amiba disease and Jadhi disease.
: Nifuratel Vaginal Tablets; Registration number: H20150514; Production plant: DOPPEL FAMACEUTICI S.R.L.; Production address: Via VOLTURNO 48, QUINTO DE' STAMPI 20089 ROZZANO, MILANO.
the drug's instruction manual, Adaptation/Functional Treatment, indicates an increase in vulva, vaginal infections and white belts caused by bacteria, thyroids, mold and Candide.
, illegal import and sale, a minimum penalty of 1.5 million yuan in accordance with the new version of the Drug Administration Law, prohibit the import of drugs with insanity, adverse reactions or other reasons endangering human health.
, medicines shall be imported from ports where drugs are allowed to be imported, and enterprises that import drugs shall file a record with the drug supervision and administration department at the place where the ports are located.
customs shall go through customs clearance procedures on the basis of the customs clearance documents for imported drugs issued by the drug supervision and administration department.
there is no customs clearance document for imported drugs, the Customs shall not release them.
supervision and administration department at the port where the port is located shall notify the drug inspection agency to conduct spot checks and tests on imported drugs in accordance with the provisions of the drug supervision and administration department under the State Council.
to allow the import of drugs shall be proposed by the drug regulatory department under the State Council in cooperation with the General Administration of Customs and expected to be expected to be authorized by the State Council.
The new version of the Drug Administration Law stipulates that, in violation of the provisions of this Law, any of the following acts shall be expected to confiscate the illegal production, import and sale of drugs and illegal proceeds, as well as raw materials, accessories, packaging materials and production equipment specially used for illegal production, order the suspension of production and rectification, and shall be punished with a fine of 15 times the value of the illegally produced, imported and sold drugs and less than 30 times the value of the drugs;
If the circumstances are serious, if the certificate of drug approval is revoked until the drug production license, drug business license or medical institution preparation license is revoked, the legal representative, the principal person in charge, the person in charge directly responsible and other responsible persons shall be confiscated from the income obtained by the unit during the period of the illegal act and shall be fined not less than 30 percent of the income obtained, and shall be prohibited from engaging in drug production and operation activities for ten years until life, and may be detained by the public security organ for not more than five days and not more than fifteen days.
1, the production and import of drugs without obtaining the drug approval documents; 2, the production and import of drugs using the drug approval documents obtained by deception; 3, the production of drugs using raw materials approved without examination and approval; 4, the sale of drugs without inspection; 5, the production and sale of drugs prohibited by the drug supervision and administration department under the State Council; 6, the fabrication of production and inspection records; 7, without approval in the production process of drugs to make major changes.
If a drug as stipulated in the first to third paragraphs of the previous paragraph is sold, or if the drug-using unit uses the drugs stipulated in the first to fifth paragraph of the previous paragraph, it shall also be punished in accordance with the provisions of the previous paragraph; if the circumstances are serious, the legal representative, principal person-in-charge, person in charge directly responsible and other responsible personnel of the drug-using unit shall also have a medical and health personnel's practising certificate revoked.
import a small number of drugs that have been legally listed abroad without approval, and if the circumstances are less serious, they may be reduced or exempted from punishment in accordance with the law.
.