S.L. 458.34 Art. 19Validity of marketing authorisation.

(1) Without prejudice to sub-regulations (5) and (6), a marketing authorisation shall be valid for five years.

(2) The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the Authority.

(3) To this end, the marketing authorisation holder shall provide the Authority with a consolidated version of the file in respect of quality, safety and efficacy, including the evaluation of data contained in suspected adverse reactions reports and periodic safety update reports submitted in accordance with Title IX of Directive 2001/83/EC as amended, and information on all variations introduced since the marketing authorisation was granted, at least nine months before the marketing authorisation ceases to be valid in accordance with sub-regulation (1).

(4) Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent Authority decides, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, to proceed with one additional five-year renewal in accordance with sub-regulation (2).

(5) Any authorisation granted by the Authority which within three years of its granting is not followed by the actual placing on the market of the authorised product in Malta shall cease to be valid.

(6) When an authorised product previously placed on the market in Malta is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid.

(7) The Authority may, in exceptional circumstances and on public health grounds, grant exemptions from sub-regulations (4) and

(5) provided that such exemptions are duly justified.