Trade in medicinal products is one of the most regulated areas in the industrial sector. The fundamental principle throughout the European Union and the European Economic Area is that a medicinal product on the market can only be present based on a marketing authorization. The procedure for getting a marketing authorization is an administrative procedure and which one will be used depends on where the product will be marketed. We know a national procedure, a mutual recognition procedure, a decentralized procedure and a centralized procedure. The objective pursued by the legislation on the field of medicinal products is the protection of public health. The procedures for getting a marketing authorization are managed by the regulatory authorities. At European Union level, the authority is the European Medicines Agency (EMEA), while in Slovenia it is the Agency for Medicinal Products and Medical Devices (JAZMP). There are two types of companies in pharmaceutical sector - companies that produce innovative medicinal products and are mainly active in research for new medicinal products and companies that produce generic medicinal products that are equivalent to innovative but much cheaper because they do not need to carry out expensive researches. Depending on whether they are getting a marketing authorization for an innovative medicinal product or a generic one, the procedure is also adjusted. Innovative medicinal products manufacturers often have an interest in cooperating in the procedure or enforcing the legal assets against the issued order for generic medicinal product. Since European legislation does not explicitly state these options, this area has been repeatedly a subject to judicial decisions that fill legal vacuum in this area.
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