Regulation 345A Obligation on licensing authority to maintain list of medicinal products to which derogations have appliedF1

The licensing authority must publish a list of medicinal products to which the derogations described in Articles 5a, 8(2a) and (2b), 18a, 20 (second paragraph), 40(1a) and (3a), 48(3) and 104(3) of the 2001 Directive have applied.

The licensing authority must update the list referred to in paragraph (1) at least every six months.