+Artikolu 2 Kamp ta’ applikazzjoni
---+Article 2 1.
---+Article 2 2.

Artikolu 2 Kamp ta’ applikazzjoni

Artikolu 2

Kamp ta’ applikazzjoni

1.  Dan ir-Regolament għandu japplika għal kwalunkwe oġġett jew servizz li jiġi pprovdut għad-distribuzzjoni, għall-konsum jew għall-użu fis-suq Komunitarju kemm jekk bi ħlas jew b’xejn (minn hawn ’il quddiem, “prodotti”).

2.  Dan ir-Regolament m’għandux japplika la għall-prodotti mediċi għall-użu mill-bniedem, kif definit fid-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill tas-6 ta’ Novembru 2001 dwar il-kodiċi tal-Komunità li għandu x’jaqsam ma’ prodotti mediċinali għall-użu mill-bniedem ( 1 ), jew għall-użu veterinarju, kif definit mid-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill tas-6 ta’ Novembru 2001 dwar il-kodiċi tal-Komunità rigward il-prodotti mediċinali veterinarji ( 2 ), u lanqas għal kwalunkwe tip ta’ tagħmir mediku.

1. Ħarsa ġenerali

,
Titlu Regolamentazzjoni
Article 2 1.
This Regulation shall apply to any goods or services which are supplied for distribution, consumption or use on the Community market whether in return for payment or free of charge (hereinafter ‘products’).
Article 2 2.
This Regulation shall apply neither to medicinal products for human use, as defined in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 1 ), or for veterinary use, as defined in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 2 ), nor to any type of medical device.

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors Rekwiżit

3. Standards relatati

Standards
Sors Rekwiżit
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