Licensing Requirements for Third Party Logistics Providers

[regularengineer]

For a third-party logistics providers that will only be providing packaging, storage, and labeling activities (sublabeling only - no changes to the manufacturer's label), is anyone aware of the licensing requirements?

I reviewed PMDA and it seems a license is required for both pharmaceutical and medical device products. Sites must also be registered with MHLW. I'm unclear though on what the quality requirements are - it seems that Articles 19 and 26 require documentation demonstrating quality control, but not sure if this means they need a proper certificate demonstrating compliance to MHLW MO 169.

Any insight would be most helpful,

 

[regularengineer]

Following up here - it seems that a manufacturing license can be obtained by the third party, which would allow them to perform the activities mentioned. There are also requirements for product and site registrations and the employment of certain specialized personnel.

Would be curious if anyone knows more...