Explanatory note

These Regulations amend the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989 which prescribe fees in connection with applications and inspections relating to licences and certificates granted under the Medicines Act 1968 so far as they apply to medicinal products for human use only.

These Regulations increase fees payable for application for the grant of product licences, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates (regulations 5, 6 and 17), for variations of such licences or certificates (regulations 7, 8 and 17) and for their renewal (regulations 17 and 18). They also increase the fees payable in respect of inspections of sites carried out in connection with applications for, or during the currency of, such licences or certificates (regulation 20).

These Regulations make various other amendments as follows:—

• they make permanent a temporary provision for a reduced fee relating to applications for product licences for certain surgical materials (regulations 2, 15 and 17(c));

• they extend the definition of complex application and alter the distinction between complex, simple and standard applications, which is relevant for determining fees for applications for the grant, variation and renewal of licences (regulation 16);

• they extend the provisions on waiver of fees (regulation 22);

• they provide for the fee payable where applications for renewal are submitted more than four months before a licence is due to expire (regulations 3 and 14(b));

• they provide for inspection fees to be equally divided between applicants who name the same site of manufacture (regulations 4, 7, 11 and 13);

• they make provision for the fee payable in respect of applications made at the same time to renew product licences for medicinal products which are identical except for their strength (regulation 19(b));

• they make provision for the fee payable in respect of applications to vary licences where such variations are identical (regulation 18(e)) or where no separate assessment is required (regulation 10);

• they provide for fees which are payable by small companies as defined by these Regulations, to be paid by instalments (regulations 14(c), 21 and the Schedule).