S.L. 458.34 Art. 15Examination of application.

(1) In order to examine the application submitted in accordance with regulations 5 and 7, the Authority -

(a) shall verify whether the particulars submitted by the applicant are in terms of the provisions of these regulations and examine whether the conditions for issuing a marketing authorisation are complied with;

(b) may submit the medicinal product, its starting materials and, if need be, its intermediate products or other constituent materials, for testing by an Official Medicines Control Laboratory or by a laboratory designated for that purpose by the Authority in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with regulation 5(1)(c)(ix) are satisfactory;

(c) may, where appropriate, require the applicant to supplement the particulars accompanying the application in respect of the items listed under regulations 5(1)(c) and 7, in which case, the two hundred and ten days referred to under regulation 12 shall be suspended until such time as the supplementary information required has been provided. Likewise, these time limits shall be suspended when the applicant is given the opportunity of providing an oral or written explanation.

(2) The Authority:

(a) shall verify that manufacturers and importers of medicinal products coming from third countries are able to carry out manufacture in compliance with the particulars supplied pursuant to regulation 5(1)(c)(v) and, or to carry out controls according to the methods described in the particulars accompanying the application in accordance with regulation 5(1)(c)(ix);

(b) may allow manufacturers and importers of medicinal products coming from third countries, in justifiable cases, to have certain stages of manufacture and, or certain of the controls referred to in paragraph (a) carried out by third parties; in such cases, the verifications by the Authority shall also be made in the establishment designated.