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Owning a Pharmaceutical Company in Ireland

Owning a Pharmaceutical Company in Ireland

The certification of medicines in Ireland

According to the Irish legislation all pharmaceutical products must be certified before being sold. Irish pharmaceutical companies must obtain an authorization from the Irish Medicines Board before starting to sell medicines. The same Medicines Board will authorize Irish companies to export pharmaceutical products and will issue a certificate of Good Manufacturing Process Compliance for companies producing pharmaceutical productsPharmaceutical companies will also require a certificate when advertising their products, which is issued according to the Medical Products Regulations enabled in 2007.

The registration of pharmacists in Ireland

All Irish citizens wanting to practice as pharmacists are required to register with the Royal Pharmaceutical Society. Foreign individuals wanting to perform as pharmacists in Ireland are also required to apply for registration. Wholesalers of medicines in Ireland must also obtain a license from the Medicines and Healthcare Products Regulatory Agency. There are three types of licenses for wholesalers:

  • – a full license for selling prescription-only medicines (POM),
  • – a restricted license for selling general sales listed pharmaceutical products (GSL),
  • – a license for importing pharmaceutical products in Ireland.

Also, in order to distribute their products, an Irish retail pharmacy must conclude a contract with the local Primary Care Trust (PCT) or with the Health Board.

We are also at your service if you are interested in setting up a company in Ireland. The process can be completed in approximately 2 weeks and is quite simple. The documents to prepare are not many, as there are pre-completed forms that can be filed, and so, the procedure becomes quite easy. Contact us for support in company registration.

Opening a pharmaceutical company in Ireland

The first step to open a pharmaceutical company is to register the business with the Irish Trade Register. Depending on the type of activity to be undertaken, the founder must select one of the corresponding NACE codes under Section D, subsection DG from the Nomenclature of Economic Activities:

  • – 24.4 for manufacturing pharmaceuticals, medicinal chemicals and botanical products,
  • – 24.41 for manufacturing basic pharmaceutical products,
  • – 24.42 for manufacturing pharmaceutical preparations.

If you are thinking of starting a business in Ireland in the  pharmaceutical sector, our experts in company formation in Ireland will guide you through the registration procedure.

Once the company is registered, it is required to obtain a pharmacy license. There are three ways to obtain a pharmacy license in Ireland:

  • – the national route for Irish pharmacy graduates,
  • – the European route for EU country graduates,
  • – the third country route for non-EU candidates.

For complete information about the requirements for obtaining a pharmacy license please contact our Irish specialists in company incorporation.