When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a narrow window.
Now is the time to get an early start organizing and planning your Establishment Registration SPL for 2015.
Establishments (Facilities) that manufacture, prepare, propagate, compound or process drugs commercially distributed in the U.S. or offered for import to the U.S. must be registered within 5 days of beginning operations. An annual renewal is then required between October 1 and December 31 each year to register the Establishment for the next calendar year. These submissions must be in SPL (electronic) format and must be submitted via the FDA Electronic Submission Gateway (ESG).
I recommend that your Regulatory Affairs group meet to review the previous year SPL in mid- to late-July, confirm the content or make updates and then schedule Establishment Registration submissions. This approach helps you manage the 3rd and 4th quarter submission crunch. Establishment Registration SPLs can be produced now and submitted later when the 4th quarter window opens.