The Principle of Mutual Recognition, as a general rule states that, although there is a technical rule in the Member State of destination, products legally manufactured or marketed in another Member State enjoy a fundamental right to free movement guaranteed by the Treaty on the Functioning of the European Union.

According to case-law of the Court of Justice, derogations from this principle are not allowed except under very strict conditions, that is, when the measure imposed by the importing Member State is necessary, appropriate, and proportionate to satisfy legitimate reasons of public interest.

Those established in Law 39/2015, of 1 October, on the Common Administrative Procedure for Public Administrations.

Regulation (EU) 2019/515, which has been in force since April 2020. The objective of the Regulation is to improve the application of the principle of mutual recognition, by: modifying the scope of mutual recognition; the introduction of a voluntary declaration of the economic agent; the establishment of a problem solving system; and improving administrative cooperation.

A voluntary declaration of the legal marketing of goods for the purposes of mutual recognition (”declaration of mutual recognition”) to demonstrate to the competent authorities of the Member State of destination that the goods, or goods of this type, are legally marketed in another Member State. The declaration of mutual recognition shall be drawn up in one of the official languages of the Union, must be kept up-to-date and must have the structure established in the annexes of the regulation and contain all the information indicated therein.

The producer, importer or distributor can draw up a declaration of legal marketing of goods for the purposes of mutual recognition.

The Declaration of mutual recognition must be submitted to the Ministry authorities with regulatory powers over the affected product.