Overview of Regulatory Directives

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Presentation transcript:

Overview of Regulatory Directives Jana Klimasová, PhD. Department of pre-clinical and clinical assessment, Registration section, SIDC

EU Directive EU directives lay down certain end results that must be achieved in every Member State. National authorities have to adapt their laws to meet these goals, but are free to decide how to do so. Directives may concern one or more Member States, or all of them. Each directive specifies the date by which the national laws must be adapted - giving national authorities the room for manoeuvre within the deadlines necessary to take account of differing national situations. Directives are used to bring different national laws into line with each other, and are particularly common in matters affecting the operation of the single market (e.g. product safety standards)

EU Regulation the most direct form of EU law - as soon as they are passed, they have binding legal force throughout every Member State, on a par with national laws. National governments do not have to take action themselves to implement EU regulations EU Decisions Decisions are EU laws relating to specific cases. They can come from the EU Council (sometimes jointly with the European Parliament) or the Commission. They can require authorities and individuals in Member States either do something or stop doing something, and can also confer rights on them. EU decisions are: • addressed to specific parties (unlike regulations), • fully binding.

Eur-lex http://eur-lex.europa.eu/homepage.html - SK verzie

Eudralex http://ec.europa.eu/health/documents/eudralex/index_en.htm

Thank you for your attention!