YONSUNG
YONSUNG
Fine Chemicals
FINE CHEMICALS CO., LTD.
National Agency for the Safety of Medicine and Health Products 143-147 bd Anatole France
93285 Saint Denis cedex France
LETTER OF ACCESS
207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do,
I 858 I, Republic of Korea TEL: 82-31-351-6622 FAX: 82-31-351-6624
Nov. 08, 2016
Number of Active Substance Master File: Applicant's part version 7.0/ Restricted part version 6.0 The national ASMF reference number of FR (2012-122)
Name of Active Substance: Bimatoprost
Manufacturing site: Yonsung Fine Chemicals Co., Ltd.
207, Sujeong-ro, Jangan-Myeon, Hwaseong-Si, Gyeonggi-Do, 18581, Republic of Korea
Active Substance Master File Holder: Y onsung Fine Chemicals Co., Ltd.,
207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
The aforementioned Active Substance Master File holder hereby authorises the National Agency for the Safety of Medicine and Health Products I France to refer to and review the above mentioned Active Substance Master File in support of the following Marketing Authorisation Application submitted by Laboratoire CHAUVIN:
Name of product: VIZIBIM DUO 0.3 mg/mL + 5 mg/mL, collyre en solution Number of DCP: DK/H/2711/001/DC
Name of Applicant or Marketing Authorization holder : Laboratoire CHAUVIN
416 rue Samuel Morse CS 99535 MONTPELLIER Cedex 2, 34961,
France
The aforementioned Active Substance Master File holder commits to ensure batch to batch consistency and to inform the National Agency for the Safety of Medicine and Health Products I France and Laboratoire CHAUVIN of any change in the Active Substance Master File.
Th'e aforementioned Active Substance Master File holder hereby is informed of and accepts that the EEA National Competent Authorities, the EMA including all CHMP and CVMP Members and their experts, and the Certification of Substances Division of the European Directorate for the Quality of Medicines &
Healthcare may share the Assessment Reports of the above mentioned Active Substance Master File amongst themselves.
Sincerely,
Director of Quality Department Yonsung Fine Chemicals Co., LTD
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