Brussels, 10/07/2012 SANCO/SF/sl/ddg1.d.6(2012)997444 Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC 디렉티브 2001/83/EC의 46b(2)(b) 에따라, 사람의약품제조에사용할목적으로 EU로수입되는활성성분의 " 확인서 " 템플레이트 1. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174, 1.7.2011, p. 74) introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. 합법적공급체인에위조의약품이유입되지못하게방지하기위한, 사람의약품관련 EC 규정에관한디렉티브 2001/83/EC를개정한 2011년 6월 8일자유럽의회및이사회디렉티브 2011/62/EU(OJ L 174, 1.7.2011, p.74) 에의거하여, 활성성분수입에관한 EU 차원의규칙이확립되었다. 디렉티브 2001/83/EC의 46b(2) 에따라, EU로수출되는활성성분의제조시설과관련하여그시설의 GMP 및관리기준이 EU의것과동등함을수출국관계기관이증명하는 " 확인서 " 를동봉한경우에만활성성분을수입할수있다. 2. The template for this written confirmation is set out in annex. 이확인서템플레이트는부록과같다. 1
부록 : 발행규제기관의레터헤드 디렉티브 2001/83/EC 의 46b(2)(b) 에따라, 사람의약품제조에사용할목적으로 EU 로수출되는활성성분의확인서 확인서발행번호 ( 발행규제기관이부여 ): 1. 제조소명칭과주소 ( 해당되는경우에는빌딩번호포함 ): 2. 제조업체의허가번호 : 1 사람의약품제조에사용할목적으로 EU로수출되는다음의활성성분을제조하는상기 (1) 의제조소에대하여 : 활성성분 : 2 제조방법 : 3 이확인서를발행하는본규제기관은아래사항을증명한다. 이제조소에적용되는 GMP 기준은 EU 의 GMP 기준과비교하여동등이상이다. 최소한 EU 와동등한수준의국민건강보호를위하여, 상기제조시설을엄격하고 투명하게주기적으로관리하며, 반복적인불시실사를포함하여 GMP 의이행실태를 효과적으로평가하고있다. 1 2 3 규제기관이해당제조소에대하여허가서를발행하는경우. 허가에관한법적제도가없는경우에는 " 해당없음 " 으로표시한다. 국제적으로합의된용어를사용하여해당활성성분의명칭기재 ( 바람직하게는 INN(international nonproprietary name) 사용 ). 예 : " 화학적합성 ", " 천연물추출 ", " 생물학적공정 ", " 완제단계 " 2
기준미준수상황이발견되는경우에는그에관한정보를지체하지않고수출국이 EU에제공한다. 4 (1) 의제조소실사일자 : 이확인서의유효기간 : 이확인서의진위여부를발행규제기관에확인할수있다. 발행규제기관의주소 :. 책임자이름과직위 : 전자우편주소, 전화번호, 팩스번호 : 서명기관직인 / 일자 4 qdefect@ema.europa.eu. 3
Annex: Letterhead of the issuing regulatory authority Written confirmation for active substances exported to the European Union (EU) for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC Confirmation no. (given by the issuing regulatory authority): 1. Name and address of site (including building number, where applicable): 2. Manufacturer's licence number(s): 5 REGARDING THE MANUFACTURING PLANT UNDER (1) OF THE FOLLOWING ACTIVE SUBSTANCE(S) EXPORTED TO THE EU FOR MEDICINAL PRODUCTS FOR HUMAN USE Active substance(s): 6 Activity(ies): 7 THE ISSUING REGULATORY AUTHORITY HEREBY CONFIRMS THAT: The standards of good manufacturing practice applicable to this manufacturing plant are at least equivalent to those laid down in the EU; 5 6 7 Where the regulatory authority issues a licence for the site. Record 'not applicable' in case where there is no legal framework for issuing of a licence. Identification of the specific active substances through an internationallyagreed terminology (preferably international nonproprietary name). For example, 'Chemical synthesis', 'Extraction from natural sources', 'Biological processes', 'Finishing steps'. 4
The manufacturing plant is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the EU; and In the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country without delay to the EU. 8 Date of inspection of the plant under (1): This written confirmation remains valid until The authenticity of this written confirmation may be verified with the issuing regulatory authority. Address of the issuing regulatory authority:. Name and function of responsible person: E-mail, Telephone no., and Fax no.: Signature Stamp of the authority and date 8 qdefect@ema.europa.eu. 5