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Clause 2, Article 2 of the Law on Pharmacy stipulates: “A drug means a preparation that contains active ingredients or herbal ingredients used for prevention, diagnosis, treatment, alleviation of diseases in humans, regulation of human physiological functions, including modern drugs, herbal drugs, traditional drugs, vaccines, and biological products”.
The General Department of Customs said that during customs procedures, the Customs authorities recorded a number of cases where enterprises imported items declared as medical equipment such as vaginal capsules; tablets to relieve pain, prevent flatulence, abdominal distension and submitted a written classification of medical equipment by the authorities for customs clearance..
However, through checking the description and usage, dosage, ingredients, and mechanism of action, these imported products are classified as drugs. The General Department of Customs said this case may hide a risk of importing drugs but declaring them as medical equipment.
In addition, through monitoring by the Customs authorities in carrying out customs procedures for imported syringes (with needles) and PP plastic infusion bags, some enterprises present a written classification of medical equipment type B, issued by the agency in charge of the classification of medical equipment but others also import these items and present an import license issued by the Drug Administration of Vietnam.
Thus, the same imported product is licensed by two units.
In addition, in the process of carrying out customs procedures for standard substances, the General Department of Customs also encounters problems. Specifically, according to the guidance of the Drug Administration of Vietnam, the licensing for importing standard substances to serve the pharmaceutical industry is applicable to some pharmaceutical providers (as specified in Articles 51,52 and 53 of Law on Pharmacy). The application for import shall comply with the provisions of Article 86 of Decree 54/2017/ND-CP dated May 8, 2017 as amended and supplemented in Decree 155/2018/ND-CP dated November 12, 2018 of the Government.
When carrying out customs clearance procedures, it is necessary to present the documents specified in Article 92 of this Decree.
For those who import standard substances that do not fall into the above cases, they are not described in the Law on Pharmacy and related documents, so there are no requirements for an import license in the pharmaceutical regulations.
According to the General Department of Customs, according to the provisions of Articles 51, 52 and 53 of the Law on Pharmacy, the license to import providers of drug/medicinal ingredient testing services; providers of clinical trial services and providers of bioequivalence study services.
However, in fact, the importers of drugs are commercial enterprises (not business establishments described in Articles 51, 52 and 53 of the Law on Pharmacy) then these importers shall resell drugs to drug testing institutes and laboratories and pharmaceutical providers mentioned in Articles 51, 52, 53 of the Law on Pharmacy. The problem is whether these importers are required for import licenses under the guidance of the Drug Administration of Vietnam.
In addition, in the process of carrying out import procedures for standard substances, a number of standard substances have chemical components on the list of drugs and drug ingredients subject to special control according to Circular 20/2017 dated May 10, 2017, of the Ministry of Health.
Thus, the question is whether the standard substances that have been licensed for import under Article 86 of Decree 54/2017, must be licensed for importing chemicals under special control. Or whether standard substances that do not require an import license under the guidance of the Drug Administration of Vietnam, must be licensed for importing chemicals under special control.
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Furthermore, in the process of carrying out customs procedures for goods in the medical field, many problems have emerged such as the import policy of syringes and medical infusion bags; problems with Silnozigyn vaginal tablets and Simicarba tablets; the import of antibacterial gel. The General Department of Customs said that the problems have been sent to the Ministry of Health and the answers from the Health Ministry will be the basis to guide businesses and the customs agency.
By N. Linh/ Huyen Trang