S.L. 458.33 Art. 10Labelling particulars.

(1) The particulars for labelling listed in regulations 3, 7 and

9 whether provided in printed form or by means of the electronic package leaflet shall appear in an official language or official languages of Malta:

Provided that it will be possible for these particulars to be indicated in several languages, as long as the same particulars appear in all the languages used: Provided further that in the case of certain orphan medicinal products, the particulars listed under regulation 3 may on reasoned request, appear in one of the official languages of the Community.

(2) The package leaflet, or electronic package leaflet, shall be written and designed in such a way as to be clear and understandable, enabling users to act appropriately, when necessary even with the help of health professionals. The package leaflet, or electronic package leaflet, shall be clearly legible in an official language or official languages of Malta. When making use of the electronic package leaflet and including the details of the outer packaging through electronic means, the information shall be presented in the following order: the full details of the outer package, any information of the immediate packaging which is not found on the outer packaging, followed by the information in the package leaflet. No additional information shall be included: Provided that this shall not prevent the package leaflet or electronic package leaflet from being accessible or printed in several languages, provided that the same information is given in all the languages used.

(3) Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the Licensing Authority may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. The Licensing Authority may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of Malta.