(영문) 서울고등법원 2016.1.8. 선고 2014누58275 판결

1. The part against the defendant in the judgment of the court of first instance is revoked, and the plaintiff's claim corresponding to that part is dismissed.

2. The plaintiff's appeal is dismissed.

3. All costs of the lawsuit shall be borne by the Plaintiff.

Purport of claim and appeal

1. Purport of claim

On December 2, 2013, the defendant revoked the part of "after the change of the list of permitted matters" in the attached Form among the disposition of approval for the plaintiff on December 2, 2013, the part of "the efficacy and effect", and "the usage and capacity" among the disposition of approval for the change of Molulul and Molulululululululule.

2. Purport of appeal

A. The plaintiff;

Of the judgment of the first instance court, the part of the Plaintiff’s closure which was revoked at the following time shall be revoked. On December 2, 2013, the part of the Defendant’s "List of Permitted Time Change Order" in the attached Form among the part of the part of each permitted permission for the Plaintiff on the part of Han-co recognition, Mapoulul and Mpromoululululule, shall be revoked, respectively.

B. Defendant

The text of paragraph (1) is as follows.

Reasons

1. Details of the disposition;

A. The Plaintiff is a pharmaceutical company established on September 9, 1996 and engaged in the manufacture, import, and sales of drugs.

B. The plaintiff imported and sold "coconule" from May 31, 1996 with marketing approval from the Commissioner of the Korea Food and Drug Administration (the revision of the Government Organization Act; hereinafter referred to as "the defendant"). The plaintiff was approved for manufacturing drugs from the defendant on April 16, 2003 with marketing approval, and "the single coconule recognition of the coconule," "Cocon, Ltd.," from Jun. 20, 2003, which is the Cocon, Ltd., Scoin, Scoin, Scoin, Scoin, Ecocon-Mol, Ecoconom, Ecoconom, Ecocon, Ecocon, Ecocon, Ecocon, Ecocon, Ecocon, Ecopa, Ecocon, Ecocon, Ecocon, Ecocon, Ecocon. 2. The plaintiff constitutes "narcotics drugs in this case" under Article 2 (1) [Attachment 2 (d) of the Enforcement Decree of the Act.].

C. On December 2, 2013, the defendant ordered the plaintiff to change the item permission for the "effective and effective," the usage and capacity," and the part of the "use and capacity" among the revised instructions, as follows (hereinafter referred to as the "disposition in this case").

Pursuant to Article 57 of the Narcotics Control Act, the proviso of Article 76 (1) of the Pharmaceutical Affairs Act, Article 8 (3) 5 of the Regulations on the Safety Control of Drugs, etc., and Article 15 of the "Regulations on the Safety Control of Drugs, Etc.", based on the measures taken abroad and the results of consultation with the Central Pharmaceutical Affairs Council with regard to stability information on materials related to chemicals containing chlin infections, such as U.S. (Food Office), Europe (PRAC, CMF) and the U.S. (hereinafter referred to as the "U.S. Food and Drug Administration"), the head time is reached by taking necessary measures, such as the modification of the product approval items, within one month from the date of the instruction to change the item approval items. (b) All products after the date of the modification of the product approval certificate are already manufactured or imported shall be kept and managed by the manufacturer, including a separate description of the revised items or new description of the product items to be posted on the website (as stated below, whether the revised description of the product is possible or new description of the product.).

[Ground of recognition] A without dispute, entry of evidence No. 1, purport of the whole pleadings

2. Whether the instant disposition is lawful

A. The plaintiff's assertion

From January 2, 2014, the pharmaceutical products of this case constitute prescription drugs that must be sold according to doctor's prescriptions. The effect and effect of the pharmaceutical products of this case are modified, and doctors should prescribe the pharmaceutical products of this case according to the modified contents. Accordingly, the pharmaceutical products of this case cannot be prescribed for treatment of pain, which is no longer than 3 days, and the pharmaceutical products of this case cannot be prescribed for treatment for three or more days by limiting treatment period. The Defendant issued the instant disposition based on safety information related to pharmaceutical products of the United States and Europe, on the basis of the fact-finding method of 'FDA, Doo and Dorug 3', which does not require any instruction to regulate the pharmaceutical products of this case, so that they can no longer be used for the purpose of preventing any alteration of the regulation of the pharmaceutical products of this case from using the MA for the purpose of surveillance of cromatic patients.

(b) Related statutes;

It is as shown in the attached Table related statutes.

(1) Characteristics, operating devices, etc. of the coininator

(A) Codeer is a substance contained in opium, and it is a drug dust control used for the effect of authenticity and truth by acting in the opiums of the Middle Sea Boundary. The CYP2D6 enzyme, distributed in the body, will show the same pharmacological effect as it may be changed into active Finfin, following the CY2D6 enzymal Ambassador process.

However, it is used in the form of Slinium instead of directly injecting it as ambin because it is low, unlike ambin, it is used in the form of Slinium, and it is used as a tool for light.

(B) The early high-speed Ambassador is a person who has a genetic form and quality in the most activated state of CYP2D6 enzzyme, and is converting the cYP2D6 enzyme into the cYfin rapidly. As such, the blood concentration of dupine in the dubine is rapidly growing. Therefore, the probability that the pulmone difficulty, which is a side effect of Finfin, may occur is high.

(2) Measures, etc. taken by the U.S. Food and Drug Administration, the European Pharmaceutical Organization, and the United Kingdom Pharmaceutical Safety Agency.

(A) U.S. Food and Drug Administration

○ Data published on August 15, 2012

○○ In fact with respect to CY206 (CY2D6) by fire extinguishing, it can be used in combination with other drugs in order to suppress crypology - Acrypology or Acrypology, and it can also be used in some cryp treatment drugs. ○○ CY206 (CY2D6) by enzypium. For some people, DNA change that actively serves this efficacy is more rapid and complete crypine than other people. Dypiums are likely to use cypium more than normal hypium than normal hypium in order to suppress crypium. In addition, hypiums are likely to use hypium in combination with a single ingredient preparation or Acrypium, and may be used for partial hypium treatment drugs. In particular, hypiums and hypium drugs that require pulmonary or hypypium medication only when they use hypium in a given condition.

○ Measures related to safety information around August 2012

The Korean Food and Drug Administration of the United States takes a warning measure against the use of a cryp to alleviate the pain of the crypian. The Korean Food and Drug Administration publicly announced that there is such a danger to the early crypian who converts a simple cryp into a crypine higher than normal cryp. The Korean Food and Drug Administration of the United States strongly recommends that he will refrain from using a cryp to regulate the pain of the crypian after removing cryp or the cryp. It also requires that the alternative crypists use alternative crypology. Moreover, the crypists and nursing have to become aware of the risks of crypian treatment after removing crypine. It is more likely that the crypianian would be used within the range of the crypianian to some other crypians who have begun to use the crypianum in the first time after removing cryp.

○ Data on February 20, 2013, published

○○ Doctrine and/or hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd hyd.

(b) European Pharmaceutical Affairs and Trade Office

The European Pharmaceutical Organization, which is an affiliated organization of the European Union, has the Mediation Group (CMFh; hereinafter referred to as the "CMFh") and the Drug Surveillance Committee (PCRC; hereinafter referred to as the "PCRC") for the procedures mutually recognized and distributed for the drugs under its control. When the safety problem arises with respect to the drugs sold in the European Union, the "PCRC" shall gather and evaluate the relevant issue, prepare recommendations for the safe use of the drugs, and submit them to the "CMFh". The "CMFh" shall determine whether to accept recommendations submitted by the "PCRC".

On June 14, 2013, the European Pharmaceutical Affairs and Fisheries Agency distributed recommendations for restrictions on the use of the SDR as news report materials. The main contents of the recommendations are as follows:

PRAC recommends that it will limit the use of crypines used for relaxation of hypine pains.OCRC recommended a series of countermeasures against the concern of the safety of crypines used for hypine pain management. This would result in the crypology of the crypine report on the dead hypines after taking crypines for relaxation of hypiums. Most of the symptoms have occurred when hypine hypine hypine hypine hypines are approved as hypine hypine hypine hyposis. It should be turned to hypine hypine hypine hypine hypine hypine hypine hypine hypine hypine hypine hypine hypine hypine hypine.

The main contents of the evaluation report submitted by the "PCRC" to the "CMFh" are as follows (CMFh was reviewed on June 24, 2013 and approved it).

소아통증관리에 투여가 권고된 코데인 함유 의약품에 대한 평가보고서1. 절차에 대한 배경 정보폐쇄성 수면 무호흡증으로 편도제거술을 받은 후 코데인을 투여한 소아에서의 모르핀 독성에 관한문헌에서 기술된 증례 이후로, 마약성진통제 독성과 지속적인 위함 최소화 대책 부쪽에 대한 우려가 대두되었다. 그 이후 많은 소아가 코데인에서 모르핀으로의 초고속 또는 빠른 대사자인 것으로밝혀졌다.2. 과학적 논의2.1 도입'PRACC'는 코데인의 효능과 안정성에 대한 모든 가용정보를 평가하고 이를 근거로 통증 관리에여하도록 권고된 코데인을 함유하는 약물 (병용 약물을 포함, 수술후 진통제 포함)을 소아에게 투여시의 이점 - 위험 균형을 검토해 달라는 구체적 요청을 받았다.2.2 임상 효능에 대한 PRAC 검토2.2.1 코데인 대사의 약물 유전학, 약동학 및 약력학○ 코데인의 진통 성질은 간에서 간 마이크로좀 효소계 cytochrome P450 효소 CYP2D6에 의해그 활성 대사체 모르핀으로 전환되어 나오는 것이다. 코데인의 독성은 주로 마약성 진통제 효과에 의한 것이며 코데인에 의한 가장 흔한 이상 반응은 졸음, 몽롱함, 현기증, 진정, 숨참, 오심, 구토, 발한 등이며, 중대한 이상 반응은 호흡억제 등이고, 이보다 약한 반응으로는 순환억제, 호흡 정지, 쇼크, 심장마비 등이 있다.○ PRAC'는 성인 및 소아에서, 투여경로를 조사하는 연구를 포함하여, 진통제로써 코데인의 사용을 조사하는 판매업자들의 연구에 의해 문헌검토가 수행되었다는 것을 주목하였다. 코데인에대한 많은 양의 약동학 및 약력학 자료는 거의 대부분 성인의 조사에서 얻어졌으며, 소아 또는 유아에서의 연구로부터의 가용정보는 거의 없고, 신생아를 대상으로 한 연구는 발표된 것이 확인되지 않았다.○ PRAC'는 성인에 대해 실시된 연구 고려 시, 특히 코데인 용량을 가이드하기 위한 CYP2D6 유전형 시험결과의 해적에 대한 임상 약물 유전학 실행 컨소시엄 계통적 검토를 주목하였다. 이결과 나온 지침은 기지의 CYP2D6 초고속 대사자 및 불량한 대사자 표현형을 가진 환자에서코데인 사용을 피할 것과 모르판 또는 비마약성 진통제와 같은 대체 진통제를 고려할 것을 강력히 권장한다.2.2.2 코데인의 효능에 미치는 연령의 영향연령 제한이 있는 제품에서, 코데인의 입증된 안전성 및 효능 부족을 토대로 12세라는 연령 한계가 제품특징요약의 대다수에서 언급되었음이 주목되었다. 'PRAC'는 코데인을 대사하는 효소시스템이 12세까지 완전하게 성숙되는 것으로 고려된다는 것을 암시하는 검토자료를 고려하여, 이 연령제한을 적절하다고 간주하였다.2.2.4 임상효능에 대한 PRAC'의 결론○ 따라서 가용 효능 자료를 토대로 하여 ‘PRAC'는 코데인을 포함하는 약물이 파라세타몰 및 이부프로펜과 같은 다른 진통제 단독사용으로 완화되지 않는 급성 중등도통증의 치료에서 효능이입증됨이 인정되지만, 소아의 수술 후 통증 관리에 비스테로이드성 항염증 약물 및 비 마약성진통제와 같은 다른 진통제에 비해 코데인의 진통 프로파일이 우월하다는 강력한 증거는 없는것으로 결론을 내렸다.○ 코데인의 대사를 책임지는 효소계는 약물흡수, 분포, 신장 클리어런스 면에서, 12세까지 성인과 유사한 대사 행동을 보이도록 완전히 성숙하는 것으로 간주할 수 있다.○ 용량은 보통 성인의 경우 1일 최대 240%, 6시간마다 30 ~ 60㎎이 통상적으로 권고된다. 이것은 특히 초고속대사자들에게의 코데인 투여와 관련된 확증된 위험 때문에 특히 중요하다.'PRAC'는 3일 후 효과적인 통증 완화가 관찰되지 않으면, 투여 약물을 변경하는 것을 고려할필요가 있을 것으로 봤다.2.3.1 중대하며 치명적인 소아에 대한 보고서 요약마약성 진통제 독성이 모든 연령에서 발생할 수 있다는 것이 인정받았지만, ‘PRAC'는 현재 증거가 소아의 경우 코데인 투여를 통한 통증치료에 의해 생명을 위협하거나, 치명적인 호흡억제라는특수한 리스크를 보유하고 있으며, 특히 이미 기도가 약화되고 수술 후 통증 완화가 필요한 특별한 하위 집단의 환자의 경우 더 위험함을 시사한다고 결론을 내렸다.2.3.2 임상 안전성에 대한 PRAC'의 결론따라서 위험을 적절하게 최소화하기 위하여, ‘PRAC'는 CYP2D6 상태에 관계없이, 코데인을 포함하는 약물이 소아의 통증관리에서 12세 이상의 소아에만 투여해야 하며 폐쇄성 수면 무호흡증으로편도선절제술 그리고/또는 아데노이드 편도절제술을 받는 18세 미만의 모든 소아 환자에게 금기해야 한다고 보았다. 마약성 진통제 독성의 징후 및 증상에 대한 경고문을 제품정보에 실어야 한다.또한 1일 최대 사용량 및 사용지속기간에 제한을 두어야 한다.2.6 전반적인 논의 및 이점 위험평가O PRAC'는 신생아, 유아 및 어린 소아가 마약성 진통제 독성에 좀 더 불가항력적일 수 있다는의견을 표명하였다. 이 위험을 적절하게 극소화하기 위하여, 12세 이상의 소아에서 코데인의대사에 책임있는 효소계가 성인의 것과 유사할 것으로 고려되므로, PRAC'는 12세가 넘는 소아에서만 코데인을 사용해야 한다고 고찰하였다. 또한 CYP2D6는 광범위 다형에 따라 투여에대해 더 낮은 반응을 나타낼 가능성이 있는 불량한 대사자와 마약성 진통제 독성이 중대하며치명적인 이상 반응의 위험에 있는 초고속대사자가 존재한다.'PRAC'는 코데인을 처방하기 전에 환자의 유전형/표현형 스크리닝을 실행하는 것은 임상에서실현가능하지 않으므로 다른 인구군에서 초고속 대사자의 유병률의 측정치 및 마약성 진통제독성의 징후 및 증상을 포함하여 이러한 위험을 강조하기 위해 직질한 경고가 권고되었다.O PRAC'는 코데인이 천정효과를 가지며, 약물반응이 용량 의존적임을 나타낸다고 결론을 내렸다. 따라서 'PRAC'는 실현 가능한 경우 체중을 토대로 정확하게 투여하고, 3일로 사용지속기간을 제한하고 소아용량범위를 0.5 ~ 1mg/kg으로 하는 것이 적절하다고 고찰하였다.○ 위의 모든 것을 주목하여, PRAC'는 소아에서 급성 중등도 통증의 관리에 투여를 권고한 토데인을 포함는 제품의 이점…위험 균형은 우호적이며, 그 의견에 대한 별첨 [뒤에서 보는 변경지시문(Annex III)을 말한다]에서 착수한 합의된 적응증, 금기, 경고 및 기타 제품정보의 변화에 좌우된다.2.8 제품정보의 변화○ 4.1항[뒤에서 보는 변경지시문(Annex II)의 4.1항을 말한다]에 대해, 'PRAC'는 코데인을 포함하는 약물은 다른 진통제가 통증을 완화하지 못했을 때만 사용해야 한다고 고찰하였다. 마약성진통제 독성 위험을 극소화하기 위하여, 코데인 대사 효소성숙에 대한 검토된 자료 및 입증된지식을 토대로 하여, 시스템이 성인과 유사한 것으로 고려되는 12세 이상의 소아 (children)에게코데인 사용을 제한하는 것이 적절하다고 고찰하였다. 통증강도에 대해 ‘PRAC'는 가용 자료가코데인의 진통 효과는 고용량에서 조차 중증 통증의 경우 크지 않다는 것을 입증하는 강력한증거를 제공한다고 보았다. 따라서 적응증은 코데인이 효능을 나타내는 다른 종류의 급성통증을 포함할 만큼 충분히 포괄적인, 급성 중등도 통증(acute moderate pain)으로 한정되나, 다른진통제로 완화되지 않을 경우에 한한다. 결론적으로, ‘PRAC'는 12세 이상 환자들(patients)의파라세타몰 또는 이부프로펜과 같은 다른 진통제 단독 투여에 의해 완화된다고 사료되지 않는급성 중등도 통증의 치료에 적응증을 둘 것을 권고하였다.○ 4.2항 뒤에서 보는 변경지시문(Annex III)의 4.2항을 말한다]에 대해, PRAC는 코데인을 포함하는 약물 사용 지속 기간을 검토하였고, 유효한 자료를 토대로, 코데인 사용을 최단 기간 동안최저 유효 용량으로 제한하는 것이 필요하며, 최대 사용지속기간은 위험 극소화 조치의 일환으로 3일까지로 제한해야 한다고 결정하였다. 유효한 통증 완화가 되지 않는다면 의사의 견해를 구해야 한다는 조언도 추가하였다.

The main contents of the revised instruction (Anex III) attached to the above evaluation report are as follows:

product specialty 4.1 - In the case of products which are permitted only to a patient with a limited capacity of not less than 12 years of age" (in the case of products with a limited capacity of not less than 4 years of age, referring to the maximum of 12 years of age if they are not deemed to be alleviated by her own) or other dust control such as her pent," at intervals of not less than 4 years of age. In the case of products with a limited capacity of not more than 12 years of age: 4 years of age should be reviewed at intervals of not more than 10 years of age for each of the specific age, and the maximum applicable capacity of her products should be reflected at intervals of not more than 10 years of age in the case of products with a high capacity of less than 4 years of her own. It should be recommended that the maximum applicable capacity of her products should not be less than 10 years of age, namely, for the treatment of her pains.

On June 28, 2013, the European Pharmaceutical Affairs and Fisheries Agency published the fact of approving the "PCRC" recommendation of the "Certified Mh", and the following contents are included in the publication data:

Information for health and medical professionals - During the shortest period of 12 years of age or older, which cannot be relaxed by any other advanced control such as Pakistan or Epidle, he/she is recommended to administer only to patients of 12 years of age or older. - The ecode shall use the minimum amount of care during the shortest period. - The term is as follows; as long as there is a significant and life threat, the risk of reaction increases; all children who have undergone the surgery for removal of pulmonary water (0 to 18 years of age) and/or cY2D6 early high-speed, who have undergone the surgery for removal of pulmonary water, and thus, they do not recommend the use of the fin toxicity symptoms because women-code whose respiratory function has been weakened.

○ Data on news reports from June 28, 2013

○○ was confirmed to have been used only to treat pains even when 12 years of age or older cannot be replaced by other advanced control, such as Paria or Ebane. In the case of using a drug for a child, the minimum effective capacity should be used in accordance with the doctor’s recommendation. This is because, as a result from the method of accepting a part of a patient’s body in the body, rare but may have a high risk of being exposed to serious side effects, and in the case of a child, it may be sensitive to a large amount.

○ Madhosphospatt 15mgs

A person shall be appointed.

(3) Measures by the Ministry of Food and Drug Safety

(A) In the draft of an order to modify the item license of the codepient drug, the treatment period was limited to three days. However, the Committee for the Subdivision of Narcotics, etc., under the Ministry of Food and Drug Safety, held a meeting as follows with respect to the "whether the 3-day restriction on the treatment period of the codepient drug" under the Ministry of Food and Drug Safety, and amended the wording as in the present.

A person shall be appointed.

(B) On August 17, 2012, the Director General of the Ministry of Food and Drug Safety sent 'the following' to nationwide doctors, etc.:

○○ For the safe use of pharmaceutical products, additional information for parents and nursing - any specific cattle may cause adverse effects that threaten life, such as taking-patch pulmonon pulmonon or death, etc. due to an anti-satisony control.- The signs of serious side effects of a child with respect to the relevant product may include abnormal surface, confusion, respiratory difficulties, and pulmonon pulmonon, etc., and the treatment should be sought immediately upon the occurrence of these signs for the child.* Additional information for medical specialists - for the treatment of pulmonary Smoking - or urine datch datch datch datch datch datch hatch hatch hatch hatch hatch hatch hatch hatch hat hat hat hat hat hat hat hat hat hat hat hat hat hat hat hat hat hat hat hat ch hat hat.

(C) On June 19, 2013, the Defendant announced a pharmaceutical company, such as the Plaintiff, etc. that imports, manufactures, and sells cocode content materials, “The result of the examination of the use of codemic content materials by the Pharmaceutical Affairs Evaluation Committee (PRAC) of the European Pharmaceutical Affairs Evaluation Committee for the Surveillance of Drugs (PRC) to children, and the recommendation, such as using them to children aged 12 or older, is being reviewed as to whether it is necessary to take domestic measures, such as the modification of the permitted matters for the codeption. By July 3, 2013, the Defendant notified the Pharmaceutical Affairs Commission of the opinion on the modification of the permitted matters for the codeption and the plan for measures to be taken as the shipment.”

(D) On January 2, 2014, the Defendant directed the Ministry of Health and Welfare, the Korea Medical Association, the President of the Korea Pharmaceutical Safety Management Agency, the Korea Pharmaceutical Safety Management Agency, etc., to the effect that “the measures to issue an order for the alteration of the treatment period during the instant disposition may be suspended if there is side effects (finine toxicity) through side effect monitoring, etc., and in the absence of side effects, it may continue to be used, but in this case, it shall be allowed to use it for the shortest period in consideration of the patient’s symptoms mitigation, etc.” Therefore, the Defendant notified that “the measure is not meaningful that the treatment period should be restricted to three days in a lump sum,” and notified that it should refer to the work.”

(4) Guidelines, etc. for pain treatment of WHO

In order to alleviate cancer pains presented by the World Health Organization (WHO), the guidelines for pain treatment were presented as follows:

The World Health Organization, for the adults of the World Health Organization, has developed a three-stage shooting bridge in order to reduce the pain of adults.In the event of a climatic pain, it is necessary to immediately use a climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic climatic

(5) Cases of side effects

From 2010 to 2012, the cases of side effects of preparations in Korea include 11 cases in Hobbebbee, 164 cases in lubbee, 164 cases in flusium, 2 cases in flusium, and 5 cases in blusium.

[Ground of recognition] Each entry of Gap evidence 2 through 8 (including paper numbers), Eul evidence 1, 3 through 6, 8 through 11 (including paper numbers), and the purport of the whole pleadings

D. Determination

(1) Relevant legal principles

According to Article 57 of the Act on the Control of Narcotics, Etc., the Pharmaceutical Affairs Act applies to the manufacture, control, etc. of narcotics and psychotropic drugs except as otherwise provided for in this Act. According to Article 2 subparagraph 2 (d) of the Act and Article 2 (1) [Attached Table 1] of the Enforcement Decree of the same Act, Kohman constitutes narcotics. Meanwhile, according to Article 76 (1) 4 of the Pharmaceutical Affairs Act, "the cases of manufacture, import, or sale of drugs, etc. which have been or are likely to have been harmful to national health", the Minister of Food and Drug Safety may order manufacturers, persons who have obtained marketing approval, importers, etc., to prohibit the manufacture of drugs, etc., to prohibit the import of drugs, etc., or to suspend the manufacture of drugs, etc., in whole or in part, within one year, but if it is deemed that the purpose of permission or report can be achieved by changing the composition, prescription, etc. of the drugs, etc., he/she may order to change only the composition and prescription.

Meanwhile, comprehensively taking account of each of the above provisions and Articles 8(1) and 48(3) of the Regulations on the Safety of Drugs, Etc., the Defendant may order modification of the original permitted matters concerning ingredients and prescriptions in cases where it is necessary to revise the permitted matters because new data related to the safety and effectiveness of drugs, etc. already licensed are obtained and new data related to the safety and effectiveness of such drugs, etc. are further confirmed as a result of the review that there is a concern about causing harm to the public health and as a result of the review. In light of the fact that Article 76(1)4 of the Pharmaceutical Affairs Act, which serves as the basis of the instant disposition, and the requirements thereof are defined as an indefinite concept, the instructions for modification of permitted matters under the above Pharmaceutical Affairs Act, which the administrative agency grants discretion in determining whether such requirements are met. Meanwhile, in principle, judicial review of discretionary acts is subject to whether there is deviation or abuse of discretionary authority, and the review of whether to deviate or abuse of discretionary authority is subject to determination of mistake and violation of the principle of proportionality and equality (see, e.g., Supreme Court Decision 2013Du1313.

(2) As to whether the grounds for disposition are recognized

Considering the characteristics of Ambassador effects, the safety measures of the U.S. Food and Drug Administration and the European Medical Agency, etc. that are converted into fin in the body, it is reasonable to see that the disposition of this case is likely to cause or threaten to cause harm to national health because it is likely to cause side effects if leaving the three-way prescription autonomously. According to the safety-related measures of the U.S. Food and Drug Agency or the European Medical Agency, etc., the disposition of this case is taken on the ground that the two-way prescription was conducted on the ground, and the U.S. Food and Drug Administration or the safety-related measures of the European Medical Agency are taken on the part of the child who administered the two-way, and there were side effects such as difficulty in respiratory, death, etc., and the difficulty in respiratory administration due to the three-way medication in the Republic of Korea. Therefore, it is recognized that the grounds for disposition of Article 57 of the Narcotics Control Act and Article 76 (1) 4 of the Pharmaceutical Affairs Act are recognized.

(3) As to deviation from and abuse of discretionary power

(A) Of the instant disposition, the part on the effect and effect of the instant disposition

In full view of the above-mentioned facts and other circumstances as seen above, the part of "effective and effective" among the dispositions in this case constitutes deviation or abuse of discretionary power, as it is necessary for the public interest.

① The Food and Drug Administration of the United States revealed the risk of crypine medication and/or cryposis in the data published on August 15, 2012, the safety information related measures around August 2012, the data published on February 20, 2013, and the risk of cypine medication and/or crypine medication to cryp patients who received cypine crypism, and did not take measures to restrict the efficacy and effect of cryp medicine, such as the part of cypine in the instant disposition. However, according to the data published on August 15, 2012 by the Food and Drug Administration of the United States of America, in the case of crypists, it pointed out that cypine is likely to have higher level than normal crypine in the case of crypists, and that it may occur in a clear state of hypine under the influence of cryp.

② 'PRAC'의 평가보고서는 통증 완화를 위해 코데인을 복용한 후 중대한 이상반응이 발생하거나 사망한 소아에 대한 보고를 계기로 하여 소아의 통증 완화에 사용되는 코데인 사용 제한 여부를 중점적으로 다루고 있으나, 소아의 통증 관리에 사용되는 코데인 함유 의약품의 안전성 우려에 대한 일련의 대책을 권고함과 아울러 코데인의 부작용 위험은 성인에도 적용될 수 있으므로 초고속 대사자로 알려진 임의의 연령의 사람들이나 수유 중인 여성에게도 사용해서는 안된다고 권고하고 있다. 또, 성인에 대한 연구 결과들은 초고속 대사자인 환자에 코데인 시용을 피할 것과 비마약성 진통제와 같은 대체 진통제를 고려할 것을 강력히 권장하고 있음을 지적하고 있다. 나아가 'PRAC'의 평가보고서에서는 코데인의 부작용 위험을 최소화하기 위하여 12세 이하의 소아에 대하여는 코데인 사용을 금지하고, 성인을 포함한 12세 이상 환자들에 대하여도, 파라세타몰 또는 이부프로펜과 같은 다른 진통제 단독 투여에 의해 완화된다고 보이지 않는 급성 중등도 통증(acute moderate pain)의 치료에 한정하여 사용할 것을 권고하고 있다[원고는 'PRAC' 평가보고서에서는 12세 이상의 소아에 대하여만 이와 같이 코데인 사용범위제한을 권고하고 있을 뿐 성인에 대하여는 이와 같은 제한을 권고하고 있지 않다고 주장한다. 그러나, 위에서 본 바와 같이 'PRAC' 평가보고서의 권고내용을 요약하고 있는 변경지시문(Annex IH) 4.1항에서는 소아 환자에게만 허가된 제품의 경우에는 코데인 사용범위제한의 권고대상을 '12세 이상의 소아(children older than 12 years of age)'라고 표시하고 있는 반면 특정 연령대에 제한없이 허가된 제품의 경우 코데인 사용범위제한의 권고 대상을 '12세 이상의 환자(patients older than 12years of age)'라고 표시하고 있다. 또, 유럽 의약품청의 2013. 6. 28.자 발표 자료의 '보건 의료 전문가를 위한 정보'란에서는 '이제 코데인은 파라세타몰 또는 이부프로펜과 같은 다른 진통제에 의해 완화될 수 없는 급성 중등도 통증의 12세 이상 환자(patients)에게만 투여하도록 권고된다'고 기재되어 있다. 이와 같은 'PRAC' 평가보고서의 내용과 위에서 본 바와 같이 'PRAC' 평가보고서는 소아 뿐만 아니라 성인의 경우까지 아울러 권고 대상으로 삼고 있는 점 등에 비추어 보면, 'PRAC' 평가보고서에서는 결론적으로 12세 이상 소아 환자 뿐만 아니라 성인에게도 위와 같은 사용범위제한을 권고하고 있다고 봄이 타당하다..

③ According to the WHO’s guidelines for pain treatment, the CHO does not appear to have been classified as a serious control of narcotics for the pain of light, while the CHO does not seem to have been used as a shower only for the acute male, but it is recommended that the CHO will use it as a supplementary measure when the pain continues to exist or increases after using it first from the control of non-narcotics drugs, such as ice slurine and alpane.

④ In the evaluation report, the "PRAC" confirms that a child suffering from side effects of cryposis is an initial and high-speed ambassador of crypine, and, in the case of an adult elementary-high-speed ambassador patient, the crypian crypian crypian crypian crypian crypian crypian crypian crypian crypian crypian crypian crypian crypian crypump in order to minimize the risk of the use of the crypian crypian crypine, and the crypheric crypheric crypian crypian cryp, etc., the scope of the use of the crypian crypian cryp is limited as above. Whether the crypian cryp is an initial or high-speed crypian cryp.

⑤ Based on the results of the evaluation of the "PRAC" evaluation, the contents of the recommendations made by the European Medical and Drug Administration, and other data such as WHO's guidelines to recommend the supplementary use of control of narcotics such as chosia, and the safety and effectiveness of materials contained in the disposition of this case after reviewing the safety and effectiveness of materials contained in the chos, it is determined that the "fficacy and effectiveness" of the disposition of this case was necessary for public interest to reduce harm to the public health due to the use of chos. In addition, in light of the public interest needs, the disposition of this case prohibiting the use of medicines contained in the chosa for the treatment of chosa or non-phosa, while allowing them to be used complementaryly after taking advantage of the chose's non-narcotics chosity control.

[Plaintiff submitted e-mail correspondence as reference material by asserting that the content of the recommendation of the European Pharmaceutical Organization's recommendation from the person in charge of the 2015, 12, and 24's recommendation was confirmed to the effect that it is not applicable to adults after the date of the closing of argument in the instant case. However, in light of the various scientific basic materials supporting the rationality of the Defendant's disposition in the instant case, the content of the above e-mail correspondence alone is difficult to reverse the rationality of the instant disposition, and it is unnecessary to further examine the probative value thereof.]

(B) Of the instant disposition, the part of "use and capacity"

As a gene test, it is necessary to verify whether a patient is an ambassador of early high-speed medication. However, the European Medical Service limit the treatment period to three days in consideration of the risk of fin addiction. The subcommittee on the institute of narcotics, etc. under the former part of the Food and Drug Administration, monitoring the patient for three days in order to verify side effects on November 12, 2013, and modifying the phrase of the restriction on the treatment period of the modified instruction to the effect that the patient has no side effects after the medication for three days; the defendant, on January 2, 2014, has no side effects (Mofin toxicity) by monitoring side effects (i.e., side effects) to the patient in a timely manner; however, even if there is no side effects (i.e., the finine toxicity), it may continue to use it for a certain period of time; however, it is not meaningful that the part of the finine medicine should be used for the minimum period of time; and the part of the finine medicine should not be used for 20 days after the date of treatment.

(4) The theory of lawsuit

Therefore, all of the instant dispositions are lawful.

3. Conclusion

Therefore, the plaintiff's claim shall be dismissed in its entirety as it is without merit. Since the judgment of the court of first instance is partially unfair, the part against the defendant among the judgment of the court of first instance shall be revoked, and the plaintiff's claim corresponding to that part shall be dismissed, and it shall be dismissed as it is so decided as per Disposition.