Process of registering and marketing pharmaceutical products in Maldives

Pharmaceutical Marketing Maldives – I have been working in Pharma related company for the past few years in the Maldives. I meet a lot of companies from neighbouring countries like India, SriLanka, Bangladesh, etc who are interested in exporting and selling Pharmaceutical products in the Maldives.

There are different kinds of products that could be manufactured by a Pharma Company, some may be OTC and some would be prescription drugs. The process of approval / registration would depend on the category of product.

Volume of Business

Maldives is a very small market, but a very potential one. Volume of business would be low when we consider it as a country. The population of the entire country is around 400 thousand including the expatriates working here. If you take a small city in India, the population is much more, but you would see that the business of Pharmaceuticals is about 4 times compared to a Indian city with the same population.

Process of Registration and Exports

Like every other country, every Pharmaceutical product needs to be registered before pharmaceutical marketing Maldives. The process of registration is clearly defined by MFDA. The products which are registered gets into the ADL (Approved Drug List) which is updated every month by MFDA (Maldives Food and Drug Authority).

To get a Pharmaceutical product registered, it is quick if the product is registered in countries like Singapore, Malaysia, Indonesia, Australia, Europe, USA, etc. Products manufactured in India or any neighbouring countries cannot be registered if they do not have a valid registration in any of the earlier mentioned countries.

A prescribed form of dossier needs to be submitted with samples and it would take somewhere between 3-6 months to get a product registered.

The manufacturer should appoint a local Pharmaceutical supplier to do the registration process.

This is a brief process explained on how Pharmaceutical products are registered and sold in the Maldives.


Maldives Food and Drug Authority

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