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This is an HTML version of an attachment to the Freedom of Information request 'Copies of documents relating to correspondence between the TGA and UCB Australia in 2018 containing the keywords ‘Sodium Oxybate’ and/or ‘Xyrem’'.

ATTACHMENT A 
FOIRequest1324inrelationtoSodiumOxybateorXyrem

Therequestisforthefollowing:

“Iamseekingdocumentationthatistheactual'writtenadvice'providedtoUCBAustraliabytheTGAinregardstotheaforementionedpre‐
submissiondiscussions.Iamnotrequestinganyothercorrespondencerelatedtoorsurroundingthatwrittenadvice.

The'writtenadvice'referstopartofthecorrespondencebetweentheTGAandUCBAustraliarelateddirectlytopre‐submissiondiscussionsaboutthe
drugXyrem(SodiumOxybate).Thesediscussionstookplacein2018andwrittenadvicewasprovidedbyemailfromTGAtoUCBAustralia.Irefer
specificallytothetwopre‐submissiondiscussionsthataredescribedonpage2of,"InquiryintoSleepHealthAwarenessinAustralia‐Submission131
‐SupplementarySubmission1,"whichisuploadedat:

https://www.aph.gov.au/Parliamentary_Bus...

"TheTGAhasbeenapproachedin2018bypotentialsponsorsforsodiumoxybateandhashadtwopre‐submissiondiscussions.Writtenadvicetothe
sponsorswasprovidedbytheTGAatthetimeandnofollow‐upapplicationshavebeenreceivedtodate."

Iunderstandfurtherthatsomeofthedocumentsrelatingtothesediscussionsmaybepublishedjournalarticlesorstudies.Ifthedocumentscontain
informationthatispublishedelsewhereIamnotseekingittobereproducedinfull,Iamonlyseekingacitationorreferenceinformationsothatitis
identified…”

ScheduleofRelevantDocuments
Date
Doc. Author Addressee
Description
Pages Decision
Relevant
No.
Sectionsofthe
FOIAct
1
TGA
UCBAustralia
14/06/2018 Email:Pre‐submissionmeetingrequest
5
Releaseinfull
s22
PtyLtd
2
TGA
UCBAustralia
6/04/2018
Brief:Pre‐submissionmeeting
25
Releaseinfull
s22
PtyLtd