2021/9004/IS
EC/EFTA
IS Iceland
  • C00P - PHARMACEUTICALS AND COSMETICS
2021-06-10
2021-03-15

The Regulation sets rules on advertising of medicinal products.

REGULATION on medicinal product advertisements.

The Regulation implements title VIII of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. It applies to medicinal product advertisements, their contents and publication. Unless otherwise stated, the Regulation applies both to medicinal products for human use and to medicinal products for veterinary use. The Regulation generally allows medicinal products advertisements but states certain prohibitations. The regulation also lays down certain rules

on how advertising shall be. The main restrictions of the Regulation are that it is prohibited to advertise medicinal products for which marketing authorisation, or authorisation for parallel importing in Iceland has not been granted, magistral formula products designed by physicians and veterinarians, officinal formula products, and medcinal products which the Icelandic Medicines Agency has permitted import for. According to the Regulation it is also prohibited to advertise to the public prescription medicinal products as well as medicinal products containing substances listed in Schedules I-IV of Single Convention on Narcotic Drugs 1961, with
subsequent amendments, Schedules I-IV of the Convention on Psychotropic Substances 1971, with protocols, and in Protocol I to Regulation No. 233/2001 on habit-forming and narcotic substances and other controlled substances.