Glossary
Marketing Authorization (Product Licence, Registration Certificate)
Also writtenmarketing authorisation
The official authorisation from the regulatory authority that fixes the approved composition, manufacture, testing, and labelling of a medicine.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Marketing authorization Korean original
Related sections
WHO TRS 986 Annex 2, Part 1 의약품 제조 및 품질관리에 관한 규정 [별표 1]
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Marketing of a product, potassium iodide capsules of 65 mg equivalent to 50 mg iodine, which does not have a Marketing Authorization issued by NAMMDR.
EMA · EU GMP NCR (EudraGMDP) · 2023-03-22 -
Action taken/proposed by the NCA: Others Refusal of the national marketing authorization request of “POSACONAZOLE ELC 100 mg, comprimé gastro-résistant”.
EMA · EU GMP NCR (EudraGMDP) · 2024-02-12 -
A marketing authorization variation for transfer of the production to NBL-2 should be submitted and accepted prior to start EU production.
EMA · EU GMP NCR (EudraGMDP) · 2024-04-26
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Marketing authorization Korean originalGRM Regulatory Glossary
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