瑞士药品注册必须有国内代理吗?
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瑞士药品注册必须有瑞士国内代理吗?自己作为MAH直接申请注册是否可行,有相关法规规定吗?
2022-10-10 08:02 Chloe4hj0gj0wn1ot2pd     
2个回答

参见瑞士《Federal Act on Medicinal Products and Medical Devices》

Art. 10 Conditions for granting a marketing authorisation

1 Any person applying for a marketing authorisation must:

a. prove that the medicinal products with indications or procedures are of high quality and are safe and effective;

abisin the case of complementary medicines without indication, at any time on the basis of documentation:

   1.prove that they are of high quality, and

   2.credibly demonstrate that the medicinal product in question does not pose a risk to the safety of consumers;

b. be a holder of an authorisation to manufacture, import or conduct wholesale trade issued by the competent authority;

c. have a registered address, registered office or a branch office in Switzerland.

2022-10-10 09:04 Keeley     
识林-实木 2022-10-16 13:25

多谢您的回复。

识林也有计划收录瑞士法规。

如果您还不是向导,而且对识林账号有兴趣,可联系我,成为“向导”,分享知识换取积分和账号权限。

好的,谢谢老师的解答

2022-10-10 09:39 Chloe4hj0gj0wn1ot2pd