The European Commission has firmly requested Portugal and Slovakia to abolish unjustified and disproportionate notification requirements associated with the export of medicinal products for human use.


According to the Commission, regulations in these Member States cause obstacles to the free movement of goods in the EU Single Market (Articles 34-36, TFEU). Purchasing medicinal products for resale in another EU country is legal. However, in order to protect public health, Member States can adopt regulations which restrict parallel trade. In Portugal, wholesale exporters of medications which are classified as “at risk of shortage” must notify authorities of their intention to export and provide information regarding their export activities. In Slovakia all exports of human medicines must be reported and receive approval from the appropriate authorities. The Commission has criticised these procedures for their lack of transparency and disproportional nature. Both countries have been requested to change their laws so that trade is less restrictive. If they fail to do this within two months, the Commission can refer the case to the Court of Justice of the EU.