| 查看: 3298 | 回复: 18 | |||
| 当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖 | |||
mouse103专家顾问 (著名写手)
|
[交流]
欧盟对API提出了新要求 已有15人参与
|
||
|
欧盟规定，至2013年起出口至欧盟的API，必须有本国政府出具证明该API是由符合欧盟GMP工厂生产的。 GMP News 03/05/2012 Import of APIs from Third Countries into the European Union: Template for the written Confirmation of GMP Compliance published for Comments From 2013 on, APIs from Third Countries will be allowed for importation into the European Union when - in addition to the GMP certificate - an enclosed document from the regulatory authority in the exporting countries confirms that: The GMP standards in the exporting country are equivalent to those in the EU The manufacturing plant is regularly and rigorously controlled. These controls should be unannounced. Measures should be taken in case of GMP deviations. The EU must be immediately notified about GMP deviations (by the members states' authorities). This will enforce the Anti-Counterfeiting Directive 2011/62/EU (see also our News from 14 December 2011). On 16 April 2012, the EU Commission aligned on the WHO's model GMP certificate and created a template for comment. The deadline for comment is 1 June 2012. Please also see the Commission consultation paper incl. the template. Note: You will get first hand information about the newest developments regarding manufacture, distribution, and safety of APIs at the "15th APIC/CEFIC European Conference on Acitve Pharmaceutical Ingredients" in Budapest, Hungary, from 7-9 November 2012 |
回复此楼» 本帖已获得的红花（最新10朵）
xbqewpq» 猜你喜欢
盐酸贝西沙星
已经有0人回复
-
姜黄烯杂质
已经有0人回复
-
药物学论文润色/翻译怎么收费?
已经有169人回复
-
克立硼罗
已经有0人回复
-
米拉贝隆
已经有0人回复
-
SPME-GC-O-MS
已经有0人回复
-
求大佬收留
已经有0人回复
-
祈福面上能中
已经有141人回复
-
求Endnote官网关于《Avian Conservation and Ecology》杂志的.ens文件
已经有2人回复
-
【2027申博自荐】9篇SCI+国奖 | 水凝胶/纳米酶/生物材料 | 求博导带走
已经有1人回复
419400
铁杆木虫 (正式写手)
- 应助: 21 (小学生)
- 金币: 11890.7
- 红花: 2
- 帖子: 575
- 在线: 151小时
- 虫号: 372139
- 注册: 2007-05-15
- 专业: 微生物生理与生物化学
17楼2012-08-06 12:46:41
xbqewpq
荣誉版主 (著名写手)
魂兮
- DRDEPI: 1
- 应助: 483 (硕士)
- 贵宾: 1.827
- 金币: 8677.9
- 散金: 2014
- 红花: 36
- 沙发: 14
- 帖子: 2144
- 在线: 533.9小时
- 虫号: 1820818
- 注册: 2012-05-16
- 性别: GG
- 专业: 药物分析
- 管辖: 分析
2楼2012-05-24 12:35:35
wangati
木虫 (著名写手)
- 应助: 124 (高中生)
- 金币: 4742.2
- 散金: 20
- 红花: 2
- 帖子: 1944
- 在线: 458.5小时
- 虫号: 393309
- 注册: 2007-06-05
- 专业: 马克思主义思想史
3楼2012-05-24 15:32:02
xbqewpq
荣誉版主 (著名写手)
魂兮
- DRDEPI: 1
- 应助: 483 (硕士)
- 贵宾: 1.827
- 金币: 8677.9
- 散金: 2014
- 红花: 36
- 沙发: 14
- 帖子: 2144
- 在线: 533.9小时
- 虫号: 1820818
- 注册: 2012-05-16
- 性别: GG
- 专业: 药物分析
- 管辖: 分析
4楼2012-05-24 20:17:13
