We are a new business and trying to set our foot in the export industry. We want to export generic medicines . We are not looking at manufacturing right now. There are few questions that are causing us some troubles and we are unable to find any information on them.
- What kind of licenses are required for pharmaceutical export, apart from company registration and IEC code?
- Would we have to take specific licenses for specific drugs or does one license covers all?
- Do we have to hire a B.Pharma graduate as is the case in wholesaler’s business?
- What are the few things we should look out for as newbies in this line of business?
Would you be able to help us out with this conundrum or could you point us in the right direction? Any help in this regards would be greatly appreciated.
- For pharma export (other than company registration and IEC), you will need wholesale drug license that you didn’t mention. If you are not manufacturer, manufacturer from which you are going to get manufactured your products should compile with cGMP certification and certifications required by importing country(to which country you will export). A dossier with complete information about molecule to be exported is to be submitted along with application form for export approval from DCGI. Read in detail about Pharma Export by clicking here
- In most of case there is need to take product approval for export for every single product.
- You can hire a B. Pharmacy or D. Pharmacy or any EP for wholesale drug license.
- As a newbie, you need to look out for understanding proper licensing systems and rule & regulations. In pharmaceutical sector, we have to undergo in lot of paper work and documentation, that make it complex work. so there is need to understand and update about all laws related to drugs and medicines.
Hope above information is helpful to you..
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