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Definitions For the purposes of this Regulation, the following definitions apply:

(1) ‘lawfully marketed in another Member State’ means that goods or goods of that type comply with the relevant rules applicable in that Member State or are not subject to any such rules in that Member State, and are made available to end users in that Member State;

(2) ‘making available on the market’ means any supply of goods for distribution, consumption or use on the market within the territory of a Member State in the course of a commercial activity, whether in return for payment or free of charge;

(3) ‘restricting market access’ means imposing conditions to be fulfilled before goods can be made available on the market in the Member State of destination, or conditions for keeping goods on that market, which in either case require the modification of one or more of the characteristics of those goods, as referred to in point (c)(i) of Article 2(2), or require the performance of additional testing;

(4) ‘denying market access’ means any of the following:

(a) prohibiting goods from being made available on the market in the Member State of destination or from being kept on that market; or (b) requiring the withdrawal or recall of those goods from that market;

(5) ‘withdrawal’ means any measure aimed at preventing goods in the supply chain from being made available on the market;

(6) ‘recall’ means any measure aimed at achieving the return of goods that have already been made available to the end user;

(7) ‘prior authorisation procedure’ means an administrative procedure under the law of a Member State whereby the competent authority of that Member State is required, on the basis of an application by an economic operator, to give its formal approval before goods may be made available on the market in that Member State;

(8) ‘producer’ means:

(a) any natural or legal person who manufactures goods or has goods designed or manufactured, or who produces goods which were not the result of a manufacturing process, including agricultural products, and markets them under that person's name or trademark, (b) any natural or legal person who modifies goods already lawfully marketed in a Member State in a way that might affect compliance with the relevant rules applicable in that Member State, or (c) any other natural or legal person who, by putting its name, trademark or other distinguishing feature on goods or on the documents that accompany those goods, presents itself as the producer of those goods;

(9) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a producer to act on that producer's behalf with regard to the making available of goods on the market in question;

(10) ‘importer’ means any natural or legal person established within the Union who makes goods from a third country available on the Union market for the first time;

(11) ‘distributor’ means any natural or legal person in the supply chain, other than the producer or the importer, who makes goods available on the market in a Member State;

(12) ‘economic operator’ means any of the following in relation to goods: the producer, the authorised representative, the importer or the distributor;

(13) ‘end user’ means any natural or legal person residing or established in the Union, to whom the goods have been made available or are being made available, either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;

(14) ‘legitimate public interest grounds’ means any of the grounds set out in Article 36 TFEU or any other overriding reasons of public interest;

(15) ‘conformity assessment body’ means a conformity assessment body as defined in point 13 of Article 2 of Regulation (EC) No 765/2008.