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MAYNMAR |
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Authority |
MFDBA: Myanmar food and drug board of authority |
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website |
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if any |
from Jan 2009 ACTD |
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REQUIREMENT FOR PRODUCT REGISTRATION |
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ADMINISTRATIVE DOCUMENTS Page No:
Letter of authorisation for each and every product ------------------------
Company profile for each and every product ------------------------------
Certificate of Pharmaceutical Products – Valid Original -----------------
Original of GMP Certificate --------------------------------------------------
Photocopy of update Manufacturing License ------------------------------
Summary Drug Information Sheet ------------------------------------------
PHARMACEUTICAL DOCUMENTS
Analytical method for active substances and excipients------------------
Specimen Q.C. report on raw material (COA of raw material) ---------
Manufacturing process and Flow chart ------------------------------------
Standard procedure for in-process quality control (IPQC) -------------
Finished product specifications ---------------------------------------------
Analytical method f or finished product ------------------------------------
Original of Certificate of Analysis (same batch COA of the sample)--
Stability studies and report (of three different batches) -------------------
Packing specification ---------------------------------------------------------
Specimen of package, label and package insert ---------------------------
C. PHARMACOLOGY Page No:
Data on basic pharmacological and microbiological studies ----
Data on pharmacokinetics --------------------------------------------------
Data on Clinical pharmacokinetics -----------------------------------------
Toxicological data ------------------------------------------------------------
Teratogenicity data -----------------------------------------------------------
Mutagenicity data -------------------------------------------------------------
Bioavailability -----------------------------------------------------------------
Drug interaction --------------------------------------------------------------
Toc for maynmar, toc formate for product registration
