Article 63
1. The particulars for labelling listed in Articles 54, 59 and 62 shall appear in the official language or languages of the Member State where the product is placed on the market. The first subparagraph shall not prevent these particulars from being indicated in several languages, provided that the same particulars appear in all the languages used. 2. The package leaflet must be written in clear and understandable terms for the users and be clearly legible in the official language or languages of the Member State where the medicinal product is placed on the market. The first subparagraph shall not prevent the package leaflet being printed in several languages, provided that the same information is given in all the languages used. 3. The competent authorities may exempt labels and package leaflets for specific medicinal products from the obligation that certain particulars shall appear and that the leaflet must be in the official language or languages of the Member State where the product is placed on the market, when the product is not intended to be delivered to the patient for self-administration.