Sampling

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Normativa

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EU law

Regulation

A regulation is a general measure that is binding in all its parts. A regulation is directly applicable, which means that it creates law which takes immediate effect in all the Member States in the same way as a national instrument, without any further action on the part of the national authorities.

Directive

A directive is addressed to the Member States. Its main purpose is to align national legislation.

A directive is binding on the Member States as to the result to be achieved but leaves them the choice of the form and method they adopt to realise the Community objectives within the framework of their internal legal order.

Decision

A decision is the instrument by which the Community institutions give a ruling on a particular matter.

Other instruments

Recommendation

A recommendation allows the institutions to make their views known and to suggest a line of action without imposing any legal obligation on those to whom it is addressed (the Member States, other institutions, or in certain cases the citizens of the Union).

Opinion

An opinion is an instrument that allows the institutions to make a statement in a non-binding fashion, in other words without imposing any legal obligation on those to whom it is addressed. The aim is to set out an institution’s point of view on a question.

 

Source: www.eur-lex.europa.eu

EU legislation

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Italian legislation

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Guidance values FDA

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Worldwide regulation

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