Importation site for P.3.1

Dear Colleagues,

Another post to re-invigorate this CMC community :slight_smile:

I would be interested in your interpretation and experience on the guidance relating to activities in 3.2.P.3.1. for EU licenses.

My question is specifically on the activity ā€˜importation siteā€™.

When an EU site is performing no other activity than the ā€˜importation siteā€™, it is obvious that the site should be listed as an ā€˜importation siteā€™ and added as a variation B.II.b.2.c

If the EU site is already listed for manufacturing and/or batch release activities, is it required to specify that the site is also the importation site? While it would be clearer to specify the importation activity when adding new sites to a license, is a variation required to only clarify the importation activity for existing sites of existing licenses?

It should be noted that Manufacturing authorisation and/or GMP certificate have already been provided for the other activities and that the site would have an import license for the products. As the only EU site listed, the importation role may also be implied.

If the importation site activity must be listed, would this be considered as an editorial update or require a B.II.b.2.c variation?

Thanks in advance for your responses!


1 Like

Hi Julien,

I am just getting up and running with the new communities page! :slight_smile:
In my experience, importation is not generally included as a specific activity in 32P31 where the site performs listed activities eg manufacturing, batch release etc. I donā€™t recall any EU authority ever asking for importation site to be listed.

Kind Regards,