Ireland is currently home to nine out of ten of the world’s largest pharmaceutical companies. A lot of multinational companies are finding convenience in Ireland and over the years the pharmaceutical sector has grown to be one of the major backbones of the Irish economy.
If you want to set up a pharmaceutical company in Ireland, you have to first get authorization from the Irish Medicines Board. This license will allow your company to sell pharmaceutical products both within Ireland and outside Ireland. In the case that the pharmaceutical company will do some manufacturing, you should additionally apply for a Good Manufacturing Process Compliance certificate. According to Ireland’s Medical Products Regulations enabled in 2007, all Irish pharmaceutical companies are mandated to have a specific certificate for advertising their products.
How to open a pharmaceutical company in Ireland?
As would be expected, the first step in opening a pharmaceutical company in Ireland is to register the company with the Irish Trade Register. The founder of the company will have to choose one of the corresponding NACE codes which perfectly fits the business model under Section D, subsection DG from the Nomenclature of Economic Activities. These are:
- 24.4 for manufacturing pharmaceuticals, medicinal chemicals, and botanical products,
- 24.41 for manufacturing basic pharmaceutical products,
- 24.42 for manufacturing pharmaceutical preparations.
The next step after successfully registering the company would be to obtain a pharmacy license. Ireland offers three routes with which one can get a pharmacy license:
- the national route for Irish pharmacy graduates,
- the European route for EU country graduates,
- the third country route for non-EU candidates
How to register as a pharmacist in Ireland?
The registration of pharmacists in Ireland is done by the Irish Royal Pharmaceutical Society. Both Irish citizens and foreigners interested in becoming pharmacists in Ireland have to apply to this board.
Licenses for wholesalers in Ireland
There are three types of licenses for wholesalers in Ireland. All three licenses are obtained from the Medicines and Healthcare Products Regulatory Agency. These are:
- License for importing pharmaceutical products in Ireland.
- License for selling prescription-only medicines (POM).
- Restricted license for selling general sales listed pharmaceutical products (GSL).
For an Irish retail pharmacy to distribute its products, it is necessary that it concludes a contract with the Health Board or the local Primary Care Trust (PCT).
The process of getting the aforementioned certifications can be daunting, especially if you are a foreigner. Don’t hesitate to reach out to our specialists at SIGTAX to get assistance from experienced professionals.
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