Question 1. (Essay)Describe and provide analysis on the outcome of the following case. In your description include the rulings and reasoning of the court, as well as the importance of the case:
Case C-319/05 Commission of the European Communities v/ Federal Republic of Germany [2007]ECLI:EU:C:2007:678
Question 2. (Short Answer)Please describe the main purpose and importance of the Agreement on Mutual Recognition between the European Community and the United States.
Question 3. (Essay)Please describe, in your own words, the approval process and requirements for the 4U product manufactured by a German company. The medicinal product portion of the 4U product consists of a novel medicinal product that is a new active substance to treat diabetes. The medical device part is co-packaged with the medicinal product part. Each part of the product will be manufactured and sold in Germany. The company also plans to market and sell the product in France, Italy and Spain. The company will manufacture and sell the entire co-packaged product as set forth above. Include all applicable regulations and processes for the relevant types of product approval. (Also, identify all possible medicinal product pathways-even if they may not be applicable for this product).
Question 4. (Short Answer)For the EU, please describe (a) the requirements for a product to qualify as an Orphan Medicinal Product; and (b) the incentives provided for Orphan Medicinal Products. Please be sure to include the requirements as well as incentives.
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