• 제목/요약/키워드: 승인거부사유

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한국 바이오헬스 산업의 미국 수입거부 대응 방안 연구 : FDA 위반코드 분석을 중심으로 (A Study on the Countermeasures Taken By the Korean Healthcare and Life Sciences Industry Regarding U.S. Import Refusals: Focus on the Analysis of FDA Violation Codes)

  • 이유한;김학민
    • 무역학회지
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    • 제48권3호
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    • pp.131-150
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    • 2023
  • 본 연구는 한국 바이오헬스 산업에 대한 미국의 수입거부(Import Refusals) 대응 방안 모색을 목적으로 한다. 이를 위해 수입거부 품목과 유형에 대한 정보가 포함된 한국무역협회 통관거부사례 데이터베이스를 활용하여 팬데믹 시기의 동향 분석을 시행하였으며, FDA 위반코드(Violation Code)에 따라 거부사유까지 분석하였다. 추가적으로 단위거부율(URR)의 측정을 통해 수입거부 대응 수준도 파악하였다. 분석 결과, 한국 바이오헬스 산업에 대한 미국의 주요 수입거부 품목은 과거 콘택트렌즈에서 코로나-19 이후 진단키트와 의약품으로 확대된 것으로 나타났으며, 주요 수입거부 사유는 의료기기와 의약품 관련법의 규정 미준수와 제품 및 시설에 대한 FDA의 미승인으로 확인되었다. 한편 바이오헬스 주요 품목의 단위거부율은 산업 평균보다 높게 측정되어 미국 수입거부 대응 수준이 낮은 것으로 파악되었다. 또한 FDA 위반코드에 따라 품목별 수입거부 사유를 분석한 결과는 다음과 같다. 우선, 콘택트렌즈와 코로나바이러스 진단키트의 주요 위반사항은 부정표시(Misbranding)에 해당한다. 이는 FDA에 관련 통지나 정보가 규정대로 제공되지 않았거나, 시판 중인 기승인 의료기기(Predicate Device)와 비교하여 본질적 동등성을 입증하지 못한 경우가 많다. 반면, 의약품은 유효성 및 안전성 입증 관련 규정에 따라 신청서의 승인을 받지 못한 미승인 신약(Unapproved New Drug)에 해당한다. 결과적으로 바이오헬스 산업의 수입거부는 무역기술장벽(TBT)과 밀접한 관련이 있다.

외국중재판정의 승인거부사유에 관한 연구 -공서양속에 관한 논의를 중심으로- (A study for the refusing enforcement on Foreign Arbitral Awards - Focus on the International Public Policy -)

  • 박종돈
    • 통상정보연구
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    • 제8권1호
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    • pp.357-369
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    • 2006
  • All over the country tries to clarify the content of 'Public Policy' in recognition and implementation of Foreign Arbitral Awards : it makes comments of the international consensus of Geneva Convention(1927), New York Convention(1958) and the UNCITRAL Model Law on Public Policy, and it takes a general view of domestic laws how they deal with Public policy and Foreign Arbitral Awards. Foreign Arbitral Awards should be appropriately respected and implementation by the courts of countries encourage parties in a legal procedure to refuse enforcement by invoking "Public Policy." In order to cope with such invocations, the purport of the above recommendation on Foreign Arbitral Awards should be internationally recognized and the exceptional circumstances should be restricted unless the International Court of Arbitral Awards is not established a Dr. Holtzmann/Schwebel brought forward. In this paper suggests the list of the exceptional circumstances. Korean Arbitration Law stipulates as the Civil proceeding Law did, "good morals and the social order of the Republic of Korea" as a ground for refusing enforcement of Arbitral Awards. Studies on counteraction against invocations of Public Policy to refuse enforcement of Foreign Arbitral Awards should be developed.

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ASEAN 국가들의 외국중재판정에 관한 승인 및 집행 - 말레이시아·싱가포르·인도네시아의 법제 및 판례를 중심으로 - (Recognition and Enforcement of Foreign Arbitration Awards in ASEAN)

  • 김영주
    • 한국중재학회지:중재연구
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    • 제25권2호
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    • pp.19-47
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    • 2015
  • International arbitration is an increasingly popular means of alternative dispute resolution for cross-border commercial transactions. The primary advantage of international arbitration over court litigation is enforceability. An international arbitration award is enforceable in most countries in the world. Especially, statistics indicate of ASEAN such as Malaysia and Singapore that the vast majority of defeated companies comply with the terms of international arbitral awards against them or settle soon after the award is rendered. Unlike Malaysia and Singapore, in Indonesia, there are several grounds for refusal of enforcement of an award including where both the nature of the dispute and the agreement to arbitrate do not meet the requirements set out in the Arbitration Law. Because Indonesia does not acknowledge decisions of foreign courts, theoretically they could enforce an international arbitral award which was set aside by the court in the seat of arbitration. This paper introduces the legal system and cases of recognition and enforcement of foreign arbitration awards in ASEAN, especially Malaysia, Singapore, and Indonesia. Secondly, by comparing their law and cases, the paper emphasized the international suitability and global fitness in involved in recognition and enforcement of foreign arbitration awards.

중재판정의 집행거부와 소극적 구제 - 싱가포르의 PT First Media TBK v. Astro Nusantara International BV and others [2013] SGCA 57 판결의 분석 - (Refusing Enforcement of Arbitral Awards and Passive Remedy : Focused on PT First Media TBK v. Astro Nusantara International BV and others [2013] SGCA 57)

  • 서지민
    • 한국중재학회지:중재연구
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    • 제28권4호
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    • pp.131-152
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    • 2018
  • On October 31, 2013, the Singapore Court of Appeals handed down a landmark decision in the case of PT First Media TBK v Astro Nusantara International and Others [2013] SGCA 57. The case arose out of an arbitration in Singapore involving the Malaysian conglomerate Astro and the Indonesian conglomerate Lippo, which culminated in a USD 250 million award in favor of Astro. The final award was given to three Astro subsidiaries who were not parties to the arbitration agreement, but who were joined in the arbitration pursuant to an application by Astro. Lippo then applied to the Singapore High Court to set aside the enforcement orders. The Court of Appeals, however, reversed the High Court's decision, and found that Astro was only entitled to enforce the awards. Also, the Court of Appeals undertook a detailed analysis of the use of active and passive remedies to defeat an arbitral award at the seat and the place of enforcement, respectively. It also touches on the innovation of forced joinders of third parties in arbitrations, which have garnered significant interest in the arbitration community. This decision is therefore expected to have a significant impact on the practice of international arbitration, including in relation to how awards can be enforced or defeated, as the case may be.

국제상사중재에서의 중재합의에 관한 법적 문제점 -대법원 2004, 12. 10. 선고 2004다20180 판결 이 제기한 뉴욕협약상의 쟁점들을 중심으로- (Several Legal Issues on Arbitration Agreement under the New York Convention Raised by the Recent Supreme Court Decision of Korea of December 10, 2004)

  • 석광현
    • 한국중재학회지:중재연구
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    • 제15권2호
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    • pp.225-261
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    • 2005
  • Under Article IV of the United Nations Convention on the Recognition and Enforcement of Foreign Arbitral Awards (New York Convention), in order to obtain the recognition and enforcement of a foreign arbitral award, a party applying for recognition and enforcement of a foreign arbitral award shall supply (a) the duly authenticated original award or a duly certified copy thereof and (b) the original arbitration agreement or a duly certified copy thereof. In addition, if the arbitral award or arbitration agreement is not made in an official language of the country in which the award is relied upon, the party applying for recognition and enforcement of the award shall produce a translation of these documents into such language, and the translation shall be certified by an official or sworn translator or by a diplomatic or consular agent. In a case where a Vietnamese company which had obtained a favorable arbitral award in Vietnam applied for recognition and enforcement of a Vietnamese arbitral award before a Korean court, the recent Korean Supreme Court Judgment (Docket No. 2004 Da 20180. 'Judgment') rendered on December 12, 2004 has alleviated the document requirements as follows : The Judgment held that (i) the party applying for recognition andenforcement of a foreign arbitral award does not have to strictly comply with the document requirements when the other party does not dispute the existence and the content of the arbitral award and the arbitration agreement and that (ii) in case the translation submitted to the court does not satisfy the requirement of Article 4, the court does not have to dismiss the case on the ground that the party applying for recognition and enforcement of a foreign arbitral award has failed to comply with the translation requirement under Article 4, and instead may supplement the documents by obtaining an accurate Korean translation from an expert translator at the expense of the party applying for recognition and enforcement of the foreign arbitral award. In this regard, the author fully supports the view of the Judgment. Finally, the Judgment held that, even though the existence of a written arbitration agreement was not disputed at the arbitration, there was no written arbitration agreement between the plaintiff and the defendant and wenton to repeal the judgment of the second instance which admitted the existence of a written arbitration agreement between the parties. In this regard, the author does not share the view of the Judgment. The author believes that considering the trend of alleviating the formality requirement of arbitration agreements under Article 2 of the New York Convention, the Supreme Court could have concluded that there was a written arbitration agreement because the defendant participated in thearbitration proceedings in Vietnam without disputing the formality requirement of the arbitration agreement. Or the Supreme Court should have taken the view that the defendant was no longer permitted to dispute the formality requirement of the arbitration agreement because otherwise it would be clearly against the doctrine of estoppel.

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국제중재판정 및 집행판결 과정에서의 쟁점들에 관한 사례연구 (Case Study of Korean-French Companies' Dispute at the Arbitration Stage in the ICC Arbitral Tribunal and at the Enforcement Stage in the Korean Court)

  • 신승남
    • 한국중재학회지:중재연구
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    • 제18권1호
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    • pp.185-207
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    • 2008
  • 한국 기업과 프랑스 기업 간에 한국기업이 프랑스기업으로부터 의약품의 임상자료 등에 관한 비밀정보 (Confidential information)를 받아서 한국식품의약품안전청에 의약품 제조허 가를 받기 위해 활용하는 과정에서 체결한 비밀유지 계약 (Secrecy Agreement)의 위반행위 여부의 분쟁이 발생하였다. 이 분쟁은 비밀유지계약 내의 중재조항에 의거하여 프랑스기업에 의해 프랑스 파리 소재 국제중재 판정부 (ICC Court Arbitral Tribunal) 에 회부되었고 한국기업이 응소하여 중재판정부에서 분쟁 사실들에 관한 양 당사자 회사들의 전문가들의 증언, 준비 서면들을 검토하여 비밀유지계약 각각의 조문의 해석을 통해 중재판정이 내려졌다. 이 중재판정은 ‘외국중재판정의 승인 및 집행에 관한 뉴욕협약’에 의거하여 중재판정 집행지국인 우리나라의 법원에서 집행판결을 거치게 되었다. 이때 한국법원에서는 뉴욕협약상의 집행거부 사유들에 관한 판단을 한 후 프랑스기업의 일부 승소의 집행판결을 내렸다. 본 사례연구의 시사점을 보면, 중재조항에 의거한 ICC 중재판정부의 심사절차는 각 나라 고유의 판례나 규정보다는, 중재인들의 건전한 상식에 근거하여 중재판정이 내려졌다는 것이다. 우리나라 법원 역시 중재인의 건전한 상식에 근거를 둔 중재판정의 세부적 내용에 대하여 중재권한, 국제적 공공질서 상의 심각한 문제점이 존재하지 않은 점을 고려하여 일부분을 제외하고는 외국중재판정을 그대로 집행함을 인용하는 판결을 내렸다는 점이다. 따라서, 한국기업들이 국제분쟁에 대비하기 위해서는 중재판정이 내려진 후 집행단계에서 중재판정 내용을 바꾸려는 노력을 하기보다는, 중재 절차 진행단계에서 한국 기업에게 객관적으로 입증할 수 있는 유리한 증거들을 중점적으로 적극 활용하여 중재인들의 건전한 상식에 바탕을 둔 중재판정을 유리한 방향으로 내리도록 유도하는 것이 더욱 바람직한 것이다.

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