Type of Psyllium Laxative

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Rules ForPharmaceutical CompaniesAnd Products

Version #1.0

Final

Date issued 08/08/2011

Date of implementation 08/08/2011


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CPP: Certificate of Pharmaceutical Product

CTD: Common Technical Document

DMF: Drug Master File

EMA: European Medicines Agency, EU

FDA: Food and Drug Administration, USA

MP: ood Manufacturing Practice

!CS": !ndi#idual Case Safety "eports

M$"A: Medicines and $ealthcare products "egulatory Agency, U%

&TC: er the Counter

PMDA: Pharmaceuticals and Medical De#ices Agency, 'apan

PMS: Post Mar(eting Sur#eillance

P&M: Prescription &nly Medicine

PSU": Periodic Safety Update "eport

)PP*: )ualified Person "esponsi+le For Pharmaco#igilance

SPC: Summary of Product Characteristics

TA: Therapeutic oods Administration, Australia

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