Pre-Launch Activities Importation Requests (PLAIR)

Pre-Launch Activities Importation Requests (PLAIR)

USFDA’s PLAIR program allows the foreign drug product manufacturer for the importation of an unapproved finished dosage form drug product in preparation for market launch. [Based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA)].

An overseas manufacturer can import unapproved finished dosage form drug product into the US after the PLAIR has been granted and the Division of Import Operations has been notified of the entry number.

Typically, the PLAIR approval process will take approximately 10 business days from the date of submission; however, the processing time may be longer or shorter, depending on the number of requests received by FDA and other aspects of the request.

A PLAIR amendment can be submitted after the PLAIR has been granted. A PLAIR amendment may take up to 1- 2 business day(s) to process, however, the processing time may be shorter or longer, depending on the number of amendments received by FDA.

Important Facts to Remember

A PLAIR can only be submitted for an original pending application for unapproved finished dosage drug product (no more than 60 days prior to anticipated approval or goal date). It does not apply to approved drug applications with a pending supplement.

A PLAIR can only be submitted for an unapproved finished dosage form drug product (not for API or a bulk drug ingredient).

The PLAIR request should be submitted by the sponsor or the applicant holder on firm’s letterhead.

Before submitting a PLAIR, foreign drug product manufacturer must ensure the actual quantities planned to import.

The quantity of drug product imported into the US must match with the quantity stated in the original PLAIR submission.

The PLAIR request should be submitted only to the email address, CDER-OCPLAIR@fda.hhs.gov, at least one month before the proposed arrival date of the shipment to allow sufficient time to process the request but no more than 60 days prior to anticipated approval.

FDA won’t accept PLAIR requests from distributors, consignees, etc…

A PLAIR may be denied for one or more reasons, including but not limited to:

·       PLAIR was submitted earlier than 60 days of expected approval or decision date.

·       Foreign manufacturer does not have a qualifying facility inspection.

·       Foreign manufacturer is not within GMP compliance.

·       Deficiencies noted in the original application.