CAMBODIA CHECK LIST FOR REGISTRATION RENEWAL

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CAMBODIA CHECK LIST FOR REGISTRATION RENEWAL
CAMBODIA CHECK LIST FOR REGISTRATION RENEWAL
CAMBODIA CHECK LIST FOR REGISTRATION RENEWAL
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CAMBODIA CHECK LIST FOR REGISTRATION RENEWAL

Documents Pages
I- Administrative document.
– Application Form for Marketing Authorization
– Application Form for Analysis
– Letter of Authorization
– Certificate of a Pharmaceutical Product (CPP) ,with Cambodia specific – Original (-this CPP according to WHO format issued by the competent authority from the country of origin)
– Registration Certificate in other country if available
– Certificate of Good Manufacturing Practice (GMP) – notarized (- this GMP according to WHO format issued by the competent authority from the country of origin)
– Summary of Product Characteristics
II- Pharmaceutical document /Scientific documentation :
1) – Complete pharmaceutical dossier :
1-1: Qualitative and quantitative formula ( including active ingredient(s) and non active ingredients) 1-2 : Method of preparation : give a brief description for each stage of manufacturing with in-process control ( including flow chart ,details of batch formula and batch size) 1-3 : Analytical control of Raw Material : ( active ingredient(s) and non active ingredients) , the following details must be included: a. Specification and control methods of analysis or tests should be provided even if these are derived from Pharmacopoeias( USP,BP,EP,JP….) b. Certificate of analysis of active ingredient with its specifications
1-4: Analytical control of the finished product :
a. Specification and control methods should be provided even if these are derived from Pharmacopoeias (USP,BP,EP,JP….)
b. Certificate of analysis of the finished product with its specifications(same batch number as the samples submitted)
1-5: Stability Test : complete stability study with the following information :
a. Description of method used during the test
b. Batches examined : number of batches and batch number ( a minimum of three batches are required )
c. Conditions of storage during study ( 300C  20C , 75 % RH  5% RH)
d. Container / packing during study . Duration of study
e. Analytical method used during the stability study
f. Results and conclusions of studies should justify the proposed shelf-life printed on the packaging of the concerned product.
III- Pre-clinical dossier (Safety dossier): synthesis of studies are available on :
– Pharmacodynamic
– Toxicology
– Pharmacokinetic
IV- Clinical dossier (Efficacy dossier):

These documents should be submitted in summary . It must be given with references results of the studies ( Bibliography)

CAMBODIA CHECK LIST FOR REGISTRATION RENEWAL

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