Provides information on any manufacturing sectors or services where only citizens or a sub-set of the population in that country are allowed to own or sell.
Last Published: 7/25/2019

As a general rule, there are no absolute restrictions regarding the sale of U.S. products and/or services in Romania.  However, applicable legislation does provide specific requirements for the manufacturing, import, trade, sale, and supply of certain products and services in the country.  Foreign entities and individuals may need to obtain certain authorizations, licenses, permits, endorsements, and/or approvals and, as the case may be, to set up local/EU subsidiaries.  Some noteworthy examples are:

  • Pharmaceutical products may only be imported and sold in Romania if they are authorized for marketing in the country and their price is approved by the Romanian Ministry of Health.
  • Medical devices can only be placed on the Romanian market if they bear the CE marking.
  • Food supplements must be notified and approved by the local regulatory authorities in order to be traded in Romania.
  • Imports and sales of firearms, ammunition, and explosives are subject to specific licenses and authorizations.
  • Transportation, telecommunications, and audiovisual services are subject to licensing in Romania.
  • Trade in nuclear products has a specific legal regime and requires mandatory authorizations.
  • The trade, supply, distribution, transmission, and generation of energy generally require specific authorizations and a physical presence in Romania (subsidiary, branch, office, etc.).
  • For financial services, capital market activities, payments, and e-money institutions, a U.S. entity must obtain specific authorizations and have a subsidiary located in Romania or another EU member state.

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.