Regulatory procedure of importing HUMAN medicine in Bangladesh

Regulatory procedure of importing HUMAN medicine in Bangladesh - Overview

------------ PAGE 1 ------------ R EGULATORY PROCEDURE OF IMPORTING HUMAN MEDICINE IN B ANGLADESH 1 ------------ PAGE 2 ------------ R EGULATORY PROCEDURE OF IMPORTING MEDICINE „« STEP- 1: Documents required for inclusion of importing medicine ƒá Manufacturing Company Profile. ƒá Product Profile/ Product Dossier. ƒá Original Certificate of Pharmaceutical product ( CPP)/ Free sell certificate ( FSC) from Heath authority of Manufacturer’s country endorsed by Bangladesh High commission „X If the manufacturing country is Australia, France, Germany, Japan, Switzerland, UK or USA then original CPP/ FSC of those country will be acceptable which also have to be endorsed by Bangladesh high commission. „X If the manufacturer country is other than the seven mentioned country, then Country of origin of the manufacturer’s country and original CPP/ FSC of any of the seven mentioned countries is required. STEPs of Recipe Approval and Registration 2 ------------ PAGE 3 ------------ R EGULATORY PROCEDURE OF IMPORTING MEDICINE „« STEP- 2: Documents Submission for Recipe Approval ƒá Have to check with Drug authority whether the medicine is already approved or not „X If the medicine already approved by Drug Authority then all the mentioned documents have to be submitted in Drug Authority for approval of recipe inclusion for Renata Limited ( Local Agent) „X Local Recipe Evaluation committee will check all the submitted documents and if they are satisfied then will approve the recipe for Renata Limited. „X If the medicine is not approved by Drug Authority yet ( new molecule or first time in Bangladesh), then all the documents have to be submitted in Drug Control Committee ( DCC) „X If DCC is convenience that the new molecule strength and dosage form is essential in Bangladesh then they will approve the recipe inclusion for the new product. 3 ------------ PAGE 4 ------------ „« STEP- 3 : Product Registration/ Product License ƒá After getting the recipe approval from the Drug Licensing Authority, Renata Ltd. ( Local Agent) will submit the registration fee, analysis fee and also original packaging material and original CPP and FSC ( packaging material, CPP and FSC from the manufacturer) for the Product License. ƒá Drug Licensing Authority will finally check all the Original documents and provide the Product License. R EGULATORY PROCEDURE OF IMPORTING MEDICINE 4 ------------ PAGE 5 ------------ 5 STEPs of Recipe Approval and Registration Required Docs. Submit to Drug Authority If the medicine is already approved by Drug Authority Local recipe committee will check and if satisfied then they will approve the recipe . If the medicine is not approved by Drug Authority yet ( new molecule or first time in Bangladesh), then all the documents have to be submitted in Drug Control Committee ( DCC) After getting the recipe approval from the Drug Licensing Authority, Renata Ltd. ( Local Agent) will submit the registration fee, analysis fee and also original packaging material and original CPP and FSC ( packaging material, CPP and FSC from the manufacturer) for the Product License Drug Licensing Authority will finally check all the Original documents and provide the Product License. If DCC is convenience that the new molecule strength and dosage form is essential in Bangladesh then they will approve the recipe inclusion for the new product If we get recipe approval from the DCC, Local Agent will submit the registration fee, analysis fee and also original packaging material and original CPP and FSC ( packaging material, CPP and FSC from the manufacturer) for the Product License Drug Licensing Authority will finally check all the Original documents and provide the Product License. ------------ PAGE 6 ------------ „« L EGAL B ASIS OF T HE P ROCEDURE „Ï The Drugs Act, 1940 „Ï The Drugs ( Control) Ordinance, 1982 „Ï National Drug Policy, 2005 R EGULATORY PROCEDURE OF IMPORTING MEDICINE 6 ------------ PAGE 7 ------------ „« C HECK L IST „Ï Application from local representative appointed/ nominated by the foreign company „Ï Prescribe Form- DA- 1/ 88 ( Attached with mail) „Ï Manufacturing Company Profile. „Ï Agency Agreement. „Ï Product Profile/ Dossier. „Ï Original Certificate of Pharmaceutical product ( CPP)/ Free sell certificate ( FSC) from Heath authority of Manufacturer’s country endorsed by Bangladesh High commission „Ï If the manufacturing country is Australia, France, Germany, Japan, Switzerland, UK or USA then original CPP/ FSC of those country will be acceptable which also have to be endorsed by Bangladesh high commission. „Ï If the manufacturer country is other than the seven mentioned country, then Country of origin of the manufacturer’s country and original CPP/ FSC of any of the seven mentioned countries is required. „Ï Two sets of original packing material ( Label, Carton, Insert etc.) R EGULATORY PROCEDURE OF IMPORTING MEDICINE 7 ------------ PAGE 8 ------------ THANK YOU 8
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