The Medicines (Products for Human Use) (Fees) Regulations 2010 (revoked)

Explanatory Note

(This note is not part of the Regulations)

These Regulations revoke and re-enact in consolidated form, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2009 (“the 2009 Regulations”) as amended by the Medicines (Products for Human Use) (Amendments relating to Fees for Variations) Regulations 2009. They make amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the 1994 Regulations”) and Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Clinical Trials Regulations”).

These Regulations make provision for the fees payable under the Medicines Act 1971 and other fees payable in respect of EU obligations relating to marketing authorizations, licences and certificates in respect of medicinal products for human use.

The fees prescribed in the Regulations are revised on an annual basis following consultation and are based on an assessment of the costs associated with the functions in association with which fees are charged. The fees prescribed in the Regulations are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 19th October 2009. A summary of the consultation responses is published on the MHRA's website (www.mhra.gov.uk).

In general the overall average rate of increase of fees is approximately 1%, although in some cases individual fees will no longer be payable or new fees have been introduced.

Parts 2 to 9 and 11 and 12 and Schedules 1 and 2 provide for capital fees to be payable in connection with pre-application meetings; applications for, or variations to, marketing authorizations, manufacturer's licences, wholesale dealer's licences, clinical trial authorisations, traditional herbal registrations and certificates permitting the export of medicinal products; assistance in obtaining or renewing marketing authorizations in other EEA States; the assessment of labels and leaflets; renewals of certain manufacturer's licences; and inspections. Most of the fees were previously provided for by the 2009 Regulations (as amended).

However, these Regulations also introduce—

(a)

a new category of fee in connection with an application for a marketing authorization for a simple application which is a decentralised procedure where the UK is a reference Member State (entry 4(b) in the table in paragraph 24 of Schedule 1); and

(b)

two new categories of fee for an inspection comprising an office-based evaluation and risk assessment of documentation in relation to good manufacturing practice, good clinical practice, good pharmacovigilance practice or good distribution practice (regulation 27 and paragraph 8 of Schedule 2).

Part 10 and Schedule 3 to these Regulations impose periodic fees to be payable in connection with the holding of marketing authorizations, manufacturer's licences, registrations, authorisations and wholesale dealer's licences. The amount of the periodic fees varies according to the type of product and in some cases according to turnover.

Administrative provisions (Part 13, Schedules 4, 5 and 6) deal with time for payment and waiver or refund of both capital and periodic fees in specified circumstances. Special arrangements are provided in relation to the time of payment of capital fees by small companies.

Part 14 of these Regulations make amendments to increase fees specified in regulations 14 and 15 and Schedules 2 and 2A of the 1994 Regulations.

Part 15 of these Regulations makes consequential amendments to the Clinical Trials Regulations to provide for up to date cross-references to these Regulations.

Part 16 of these Regulations revokes earlier Regulations relating to fees for medicinal products for human use and also makes saving provisions.

An impact assessment of the effect that this instrument will have on the costs of business is available from the MHRA at Market Towers, 1 Nine Elms Lane, London SW8 5NQ.