The Regulation prescribes the procedures for deliberate release of genetically modified organisms; the procedures for issuing, extending, amending and cancelling a permit, as well as for monitoring; the procedures for providing information on circulation of genetically modified organisms; the procedures for restricting or prohibiting cultivation of genetically modified organisms; and public involvement in the decision-making process. The Regulation does not apply to the contained use of genetically modified micro-organisms; the placing on the market of genetically modified food and feed, to which Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed applies; medicinal products which contain genetically modified organisms, consist of or are produced from them, the release of such medicinal products, except risk assessment for medicinal products in accordance with Paragraphs 16 and 17 of this Regulation; and carriage of genetically modified organisms by road, railway, inland waterways, sea or air.