Regulation 10 Site inspections

Where the relevant authority carries out any inspection in connection with an application for the grant, variation or renewal of a manufacturer’s licence the applicant shall pay the relevant fee prescribed in Schedule 2.

The holder of a manufacturer’s licence shall pay the relevant fee prescribed in Schedule 2 in respect of any other inspection by the relevant authority of a site relating to that licence.

Where a manufacturing site in a third country is specified in a marketing authorisation or product licence, and the site is inspected by the relevant authority, the marketing authorisation or product licence holder shall pay the relevant fee prescribed in Schedule 2; and if there is more than one marketing authorisation or product licence in which the site in question is specified, liability to pay the relevant fee prescribed in Schedule 2 shall be divided between the holders of the marketing authorisations or product licences, as the case may be, in proportion to the number of marketing authorisations or product licences held for products manufactured at that site.

No fee is payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether an alteration or improvement to premises on that site, which was required in writing by the relevant authority as the result of that previous inspection, has been implemented.