such Green Medicine Co., Ltd. (Attorney Lee Jae-soo, Counsel for the plaintiff-appellant)

Senior Food and Drug Administration

March 17, 2004

Incheon District Court Decision 2002Guhap688 delivered on November 12, 2002

1. Revocation of a judgment of the first instance;

2. The Defendant’s order disposition on January 3, 2002, such as the destruction of medicinal substances imported to the Plaintiff, shall be revoked.

3. The costs of the lawsuit shall be borne by the defendant in both the first and second instances.

The same shall apply to the order.

1. Details of instructions and dispositions, such as the destruction of imported pharmaceutical products;

【Fact- without any dispute, Gap’s No. 1, Gap’s No. 2, Eul’s No. 3-1 through 3, Eul’s No. 1, Eul’s No. 2-2, and Eul’s No. 4

A. The Plaintiff is a company that aims at the manufacture of medicinal herbs and wholesale and retail business. On November 10, 201, the Plaintiff imported 424.15 kilograms for melting from Russia through Incheon Airport (hereinafter “this case’s green”). On December 6, 2001, the Plaintiff requested the Defendant to conduct a close inspection pursuant to Article 66 of the Pharmaceutical Affairs Act.

B. In accordance with the relevant provisions of the former Korean Pharmacopoeia (Notice of the Korea Food and Drug Administration No. 2001-2, Jan. 5, 2001; hereinafter “Korea Food and Drug Administration”) and the former Food and Drug Management Regulations (Notice of the Korea Food and Drug Administration No. 2001-28, Apr. 26, 2001; hereinafter “Import Drug Regulations”), the Defendant cut three parts from each cutting part to 5cm from each cutting part, cut off the parts of the samples collected by crushing them, measured the drying volume and 10.9% of samples collected by crushing them. The drying volume was measured as 10.9%, within the scope of “14%,” but the dried volume was measured as 35.5% of the standard value, and the Plaintiff issued a ruling on the instant green content and issued a ruling on the Plaintiff’s destruction or return order (hereinafter “the Plaintiff’s disposal order”).

2. Determination on the lawfulness of the instant disposition

A. The parties' assertion

As to the assertion that the disposition of this case is a legitimate disposition made pursuant to the relevant Acts and subordinate statutes, in light of the fact that the plaintiff does not have a regulation on melting ingredients in China or Japan, it is not reasonable grounds for health and hygiene to take a melting quantity as the inappropriate standard, and further, the reduction of melting content and the increase of melting content as soon as possible. However, if the manufacturer selects three batteries from the import drug regulations and the oriental medicine standard book to the total import melting quantity, it is unreasonable to determine the melting content of the pharmaceutical products to the extent that the melting content exceeds 35% of the total imported herb content by measuring melting the melting content of the pharmaceutical products, and thus, it is unreasonable to determine the melting content of the pharmaceutical products to the extent that the standard melting content of the pharmaceutical products in this case is inconsistent with the standard 4% standard melting content of the pharmaceutical products in this case, and thus, it is unreasonable to determine the melting content of the pharmaceutical products in this case under the premise that the melting content of the standard 1.

(b) Related statutes;

Article 44 (1) of the Pharmaceutical Affairs Act provides that the head of the Food and Drug Safetycheon shall set the methods of manufacturing, nature, efficacy, quality, storage, and other necessary standards with respect to drugs not listed in the Korean Pharmacopoeia, which require special attention to the public health and sanitation. Accordingly, in the herb specification book, the head of the Food and Drug Safety Department shall set the methods of manufacturing, nature, efficacy, quality, storage and other necessary standards after hearing the opinion of the Central Pharmaceutical Affairs Council. Accordingly, the Ministry of Health and Welfare re-announces the contents of melting them by the Ordinance of the Ministry of Health and Welfare (including the cases of melting after the string of the strings, the strings, and the strings of the strings and the strings and the strings and the strings and the 25§¯s and the 35cm content of melting in the case of melting drugs, based on the correlation between the degree of meltation of melting and the 35% content of melting drugs.

(c) Fact of recognition;

【Evidence Evidence No. 4, Evidence No. 5, Evidence No. 13-1, Evidence No. 14, Evidence No. 7, and the whole purport of oral argument

(1) Unlike Korea, in the case of China, it is defined as the horns of rhinoceros in the Chinese Pharmacopoeia, which is not the melting of the math and the math of the math, and there is no standard for the fluoring content (However, in the case of middle-class drug, it is defined as 26.65%, 37.79%, and 40.11%, respectively, by classifying starch into products, heavy products, and subordinate products). In the case of Japan, the standard for the fluoring content is set by 38% or less, while the fluoring content is defined as the fluoring of the fluoring content through the welfare internal rules.

(2) A melting has a good quality when the melting content has a good quality, but there is no data that the melting content is harmful to human body because the melting content is high (a melting melting content exceeds the melting standard is distributed in the melting time).

(3) The melting content differs depending on the relevant mountainous region or variety, and the melting content differs depending on the parts, such as the melting content decrease in the melting content against the lower part within one melting process.

(4) The amount of import for the green use of this case paid by the Plaintiff is about KRW 125 million.

(5) On January 3, 2002, the Plaintiff purchased the instant melting and separate melting 532.25 kilograms at one time, and imported only air flights differently. A separate melting 532.25 kilograms are measured as a result of a close inspection by 10.3% of drying volume and 34.4% of disposable content, and was determined as conformity assessment by the Defendant.

D. Determination

(1) As to the plaintiff's first argument, the health authorities can classify drugs and establish certain criteria for drugs in order to improve national health and establish order in distribution. In the case of melting a kind of medicine, how to determine the criteria for identification is a legislative matter to be determined by each country according to its domestic situation. In Korea, it is difficult to view that the method to find out the degree of melting the degree of melting which serves as an important criteria for classification of melting in the current scientific level is to measure the melting substance, to determine the criteria for classification based on melting the melting content in the herb specifications, to measure 5 cm from the cut part to 5 cm from the cut part, and to determine the standard by its specific method, it is difficult to view that it goes beyond the limit of delegation of Article 44 (1) of the Pharmaceutical Affairs Act as a arbitrary legislation.

On the other hand, Articles 5(1)3 and 6(2) of the Import Drugs Regulations provide that a close inspection (referring to an inspection conducted according to the standards and testing methods set by the Korean Pharmacopoeia) of melting melting melting melting melting melting melting melting melting three batteries selected as a sample. It is extremely difficult to determine whether the total melting melting melting melting meltings meet the standards set by the Korean Oriental Standards Book. In light of the fact that it is extremely difficult to distinguish a melting melting melting melting melting 1 by the relative, company, and subordinate parts and to measure melting melting melting melting her as a sample, it is reasonable to conduct an inspection based on sample in the Import Drugs Regulations, and the plaintiff's first argument is without merit (However, Article 6(2) of the Import Drugs Management Regulations amended by the Korea Food and Drug Administration Notice No. 2004-15, Mar. 4, 2004).

(2) According to the plaintiff's second argument, the measurement of melting weight and melting content is a separate inspection item, and it does not provide for a provision for the conversion of dried weight measurement into the standard value and for correction of dried weight measurement accordingly. In addition, considering the whole purport of the argument in the first instance court's inquiry into the Korea Drug and Export Association of the first instance court, it is recognized that the melting content can be affected by other people in addition to the melting volume of melting weight. Thus, as alleged by the plaintiff, when converting the dried volume of melting sample of the instant case into 10.9%, not the dried volume of 14% which is the initial measurement value, it cannot be deemed that the dried content of the melting quantity is within the standard value prescribed in the dried weight measurement, and the second argument by the plaintiff is without merit.

(3) As to the third argument of the plaintiff, the importer's determination of whether it was imported for medical purposes, or whether it was imported for other purposes, and the applicable laws and regulations vary depending on the usage reported by the importer at the time of import of melting the third argument. The plaintiff's third argument is natural to recognize that the melting of this case was imported for medical purposes. As long as the plaintiff imported the melting of this case for medical purposes, it shall be subject to a close inspection on the quality standards of melting in the customs clearance stage as prescribed by the Pharmaceutical Affairs Act, the Pharmaceutical Standards Act, the Import Medicines Act, and the Import Medicines Act. Therefore, the third argument of the plaintiff is without merit.

(4) As to the Plaintiff’s fourth argument, Article 56 subparag. 3 of the Pharmaceutical Affairs Act provides that the pharmaceutical products, the standards of which are set pursuant to Article 44(1) of the same Act, which do not meet such standards, shall not be imported. In the event that the pharmaceutical products are imported in violation of the said standards, an order may be issued to discard or take other measures against the pharmaceutical products imported under Article 65(1) of the same Act. The Enforcement Decree of the same Act or the Enforcement Rule of the same Act does not provide any provision with regard to the specific contents of “defish or other measures” under Article 65(1) of the same Act.

Therefore, if an importer imports a drug that does not meet the standards for pharmaceutical products, the defendant can take measures, such as partial discarding, reinspections, and post-inspection after customs clearance, according to the degree of violation. Unlike chemical mass products in the factory in question as natural products, quality can not be uniform and different for each individual product. In addition, in the case of melting, the measurement value of the melting drug may vary depending on which location it is cut, even if it is less than 10,000 won, and it is difficult for the importer to verify which degree of 0% of the melting drug's 10,000 won is harmful to the human body by measuring melting 20,000 won per 0,000 won after purchasing the same opportunity as the melting drug in this case, it is difficult for the plaintiff to measure the 10,000,000 won of the melting drug in this case's 0,000 won of the melting 20,000 won of the melting substance.

3. Conclusion

Therefore, the plaintiff's claim of this case is accepted on the grounds of its reasoning, and the judgment of the court of first instance which has different conclusions is unfair, and it is so decided as per Disposition by cancelling the disposition of this case and cancelling it.

Judges Lee Jin-jin (Presiding Judge)