Some companies have raised the following issue: a certain product of their company holds an "Imported Drug Registration Certificate" that is valid until April 2010. Now, they are considering applying for sub-packaging within the country. However, they are concerned about how this application might affect the certificate when it is updated or renewed.
The editor has compiled the following scenarios for reference only:
1. According to the new regulations, if the original large package registration certificate was re-registered, then the same process should be followed when applying for a new packaging format. This means that the re-registration of the large package must be completed before any changes in packaging can be approved.
2. If the product was originally imported without a large-size packaging certificate, and the current national regulations only mention the possibility of re-registering the imported large packaging, but do not require a separate large packaging certificate, then companies may still follow the old method outlined in Order No. 28. It's recommended that relevant enterprises consult the National Bureau to confirm whether re-registration is necessary at the same time as applying for additional packaging specifications (such as transport-sized packaging).
3. Companies can apply for domestic sub-packaging approval under Order No. 28, while simultaneously applying for an import large-package registration certificate for sub-packaging. During the re-registration process, according to the newly issued "No. 18 of 2009," it is possible to apply for both small and large package re-registrations at the same time.
4. Another option is to submit applications for both the large-package certificate and the sub-package certificate through a supplementary application. When the registration certificate expires, companies can apply for the import registration certificate and the large-package guarantee at the same time, in accordance with the newly promulgated "No. 18 of 2009," and then proceed to apply for the sub-package certificate via a supplementary application.
It’s important for each company to assess its specific situation and consult with the relevant authorities to ensure compliance with all current regulations. The process may vary depending on the product type, existing documentation, and the stage of the registration lifecycle.
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