'Regulations on the Safety of Human Tissues' (Subordinate legislation of 'Safety, management, etc. of human tissue act')
- Notifying member
- Korea, Republic of
- Title
- 'Regulations on the Safety of Human Tissues' (Subordinate legislation of 'Safety, management, etc. of human tissue act')
- First published
- 20/01/2004
- First EIF
- 04/12/2019
- Latest published
- 11/12/2018
- In force to
- Latest notification
- G/LIC/N/2/KOR/59
- Product categories
- List of products subject to licensing
- Attachment
- Safety Management etc of Human Tissue Act_11.12.2018.pdf 802-SAFETY AND MANAGEMENT OF HUMAN TISSUE ACT.pdf
- Nature of licensing
- Administrative purpose/measure being implemented
- Administrative body(ies) for submission of applications
-
- Contact point for information on eligibility
-
Same as the "Administrative bodies"
- Expected duration of licensing procedure
- Found by secretariat
- No
- Related document symbols
-
- G/LIC/N/2/KOR/33
- G/LIC/N/2/KOR/59
- Source
-
Korean Law Information Center https://law.go.kr/LSW/eng/engMain.do?eventGubun=060124
- Notes
-
-
G/LIC/N/2/KOR/33
Modification of specific details in existing procedures: Administrative body(ies) for submission of application
Modification of the official English name of the administrative body for submission of applications: Regional Food and Drug Administration → Regional office of Food and Drug Safety
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15. In the case of 7(b), please indicate the type of new change(s)
Modification
Please indicate the type of new change(s)
Documentation requirements (including application form)
Please elaborate the changes in detail (in one of the WTO official languages)
Registration and Modification of Exporting Country Manufacturing Establishments for Human Tissue Imports
When the head of a tissue bank intends to import human tissues, the exporting country's manufacturing establishment must be registered with the Ministry of Food and Drug Safety submitting a foreign manufacturer registration application form accompanied by a copy of the establishment authorization of the tissue bank and a copy of the certificate of import authorization for human tissues. For amendments to existing registration, the tissue bank shall submit the foreign manufacturer registration amendment application with supporting documentation evidencing the relevant changes.
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