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 products. Pharmaceutical companies will also require a certificate when advertising their products, which is issued according to the Medical Products Regulations enabled in 2007.
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:
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.
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:
Once the company is registered, it is required to obtain a pharmacy license. There are three ways to obtain a pharmacy license in Ireland:
For complete information about the requirements for obtaining a pharmacy license please contact our Irish specialists in company incorporation.