S.L. 458.33 Art. 5ALicensing Authority may require use of certain labelling forms.

Notwithstanding the proviso to regulation 8(2), the

Licensing Authority may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:

(a) the price of the medicinal product;

(b) the reimbursement conditions of social security organizations;

(c) the legal status for supply tothe patient, in accordance with Title VI of Directive 2001/83/EC, as amended; and

(d) authenticity and identification in accordance with regulation 3(q), (r) and (s).