Composition of a dossier to register a drug
Dossier type:
1. Address letter to file for the MAA to the Director of the Madagascar
Medicine Agency.
This letter has to mention:
i. The name and the address of the manufacturing site
ii. The trade name the drug, the dosage form, the mode of
administration, the pack size
iii. The indication
iv. The wholesale price. Unit price to be sold in
Madagascar(price certificate)
2. The copy of approval letter from source country .
3 The summary of product characteristics in 8 copies with the composition, the
indications selected by the authorities, the dosage, the contraindications, the
adverse effects, the interactions, and the wholesale price??.
4. Three samples of each strength where applicable
The indications on the primary and secondary packaging and on the leaflet have to
be written in one of the 2 languages spoke in Madagascar which are the malgache
(local language) language and french language.
5. A copy of the approval letter from EMA, UK or (see Annexe 9)
and if not registered in the above markets, provide no 6
6. Certificate from responsible pharmacist at manu site/PCO (check this), and/or
CoA. An example of these documents can be found in Annex 5 -8.
Original signed documents needed, authentification( legalisation) by Authority in
the source country. Templates can be provided upon request by Madagascar
Agency. If product is manufactured in Madagascar, only the signature of the Resp.
Pharmacist and CoA is required.
7. detailed Description of manu process and conditions of manufacture and
description of control procedures
8. specifications and desc of control procedures for DP and API. Indicate the
origin of the API (DS Manu site). Validation methods not described in the
Pharmacopoeia.
9. Results of the control procedures signed & dated, with the name and signature
of the qualifed person (electronic signatures also acceptable), and the batch
number must be stated for DP. Date of Analysis required, and a copy of the int
standards (eg pharmacopoeia that the test was compared to).
10. Stability studies
11. Clinical and non-clinical overviews (study reports*)
12. Method of distribution- whether POM, or hospital based medicine, for large
quantities how does the company propose to pack large quantities (logistics), who
is going to pack*
13. Worldwide registration status- where is product approved.
[Link] cert for manufacturer of the finished product (packing & release), needs
to be legalised
Exceptions
1. The laboratory in Madagascar can import the API from outside for the
Madagascar laboratory to finish the manu and packaging. The Madagascar
manu can send the artworks for review.????
FP samples, artworks should all match and be the same as what will be
commercialied in Madagascar otherwise the Agecny shall not approve the
product. Eg Sayana/Depo Provera
As long as the samples, artworks are the same as the ones to be commercialised in
Madagascar, the Company is allowed to if they produce more of the product. * 3
samples of the FP, a copy of the artworks (leaflet, label, carton) should be given to
the agency
If there is a difference btn the samples and what’s in the dossier, it’s not
acceptable.
[Link] the product that is or to be manufactured in Madagascar, that company is
exempted from providing clin/non-clinical data in the dossier for product
registration. Eg generics
if the drug has approval in source country and Madagascar*????
If the product is manufactured under licence in Madagascar a certificate is
required, which is the coA
Fanja to verify point 2.
