Changes to over-the-counter (OTC) ophthalmic products
Changes to over-the-counter (OTC) ophthalmic products
We’ve updated the policy and compliance requirements for Selling Partners to sell OTC ophthalmic drug products in our stores. Effective October 16, 2024, OTC ophthalmic drug products need to be verified through a third-party Testing, Inspection and Certification (TIC) organization.
The Manage Your Compliance dashboard shows listings for OTC ophthalmic drug products that require your actions along with the due dates under Compliance status. Listings may be subject to removal if they are not confirmed as being compliant with our policy by the specified due date.
To ensure that your listings are compliant with our policy, you must use the Manage Your Compliance dashboard to initiate a test for each product with one of the third-party TIC organizations. Once testing is requested, you’ll work directly with the third-party TIC organization to complete the testing of your products. For testing instructions, go to the Manage Your Compliance dashboard and select Add or appeal compliance.
Once we receive a test result that confirms compliance with our policy, your product will be eligible for sale on Amazon.
For more information on OTC ophthalmic drug products, please click here.
We will conduct a live webinar on October 28, 2024 at 11:00 AM Pacific Time to cover Amazon’s policy on selling OTC ophthalmic products in the US store and answer any of your questions. Click here to register!
If you have any questions regarding this policy update, please include them in the replies of this thread.
Changes to over-the-counter (OTC) ophthalmic products
Changes to over-the-counter (OTC) ophthalmic products
We’ve updated the policy and compliance requirements for Selling Partners to sell OTC ophthalmic drug products in our stores. Effective October 16, 2024, OTC ophthalmic drug products need to be verified through a third-party Testing, Inspection and Certification (TIC) organization.
The Manage Your Compliance dashboard shows listings for OTC ophthalmic drug products that require your actions along with the due dates under Compliance status. Listings may be subject to removal if they are not confirmed as being compliant with our policy by the specified due date.
To ensure that your listings are compliant with our policy, you must use the Manage Your Compliance dashboard to initiate a test for each product with one of the third-party TIC organizations. Once testing is requested, you’ll work directly with the third-party TIC organization to complete the testing of your products. For testing instructions, go to the Manage Your Compliance dashboard and select Add or appeal compliance.
Once we receive a test result that confirms compliance with our policy, your product will be eligible for sale on Amazon.
For more information on OTC ophthalmic drug products, please click here.
We will conduct a live webinar on October 28, 2024 at 11:00 AM Pacific Time to cover Amazon’s policy on selling OTC ophthalmic products in the US store and answer any of your questions. Click here to register!
If you have any questions regarding this policy update, please include them in the replies of this thread.
5 yanıt
Seller_mjWxtagaXvrJU
Some questions I have to ask :
Q) What about those who are selling in the US for the first time but have manufacturing outside of the USA? Will they need to fill out an NDA application?
Q) If a seller has not created an account yet and wants to do product testing and obtain FDA approval first, can they complete the entire process through an authorized third-party organization? Or is it mandatory to do it through Seller Central?
Q) Does a seller need any historical sales data in the US to start selling an OTC ophthalmic product on Amazon?
Q) GMP (Good manufacturing practice) certification is needed for ointment pain relief?
Q) NDC (national drug code) is needed ?
Seller_EgSrobihg8H79
Hi, I missed the webinar. How do I watch it? Also, my dashboard does not say what OTC compliance testing needs to be done by the lab. What do I tell the lab? Finally, there are 30 more sellers on this listing, are all sending to get compliance? Should I wait until someone else does?
Seller_ShnU5PznCVf6A
@Jameson_Amazon Do the individual resellers also need to do the testing? Or are the resellers just going to wait until the brand owner does the testing and then leach off of them? I was quoted $5400 USD to do the compliance testing. So it would be outrageous if only the brand owner must do this and all resellers also get the benefit for nothing. Our company needs to know ASAP how this is going to be handled because we are considering ending all sales and advertising operations on Amazon depending on the details.
