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01
Definitions #
A legal document issued by a health authority that gives a company the right to market a specific medicine.
Technical An official authorization to place a pharmaceutical product on a national market; the term is used synonymously with marketing authorization in many jurisdictions (e.g., UK pre-2012).
02
Etymology #
From product + licence, traditional British term for pharmaceutical marketing approval, used in the Medicines Act 1968 before the term 'marketing authorization' was adopted by EU directives.
03
Collocations #
- product licence holder 持有产品许可证的法人或个人
- application for a product licence 提交产品许可申请
- product licence number 每个药品包装上的许可证编号
04
Real Business Examples #
- The manufacturer applied for a product licence to sell the new analgesic across the European Union.
- The product licence number must be printed on the outer packaging of the medicine.
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05
Register & Variants #
- Register: formal
- BrE/AmE: 英国及英联邦国家常用，美国更常用 marketing authorization / product approval
06
Synonyms & Antonyms #
- Synonyms: marketing authorization, marketing approval
- Antonyms: refusal of licence
07
Common Errors #
- 误以为 product licence 等同于生产许可证 生产许可证是 GMP 监管的生产准许，而 product licence 是上市销售许可，二者不同
08
Confusable Terms #
- Manufacturing licence vs product licence
- manufacturing licence 允许生产药品，而 product licence 允许销售药品；很多公司两者都有但职责不同
09
Frequently Asked Questions
如果产品许可到期但药品仍在销售会怎样？?
在大多数国家属于非法销售，可能面临罚款、产品撤市，甚至刑事责任
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