The Medicines (Products for Human Use) (Fees) Regulations 2013 (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 2012 (“the 2012 Regulations”) and the Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012. They make amendments to the 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 authorisations, licences and certificates and registrations in respect of medicinal products for human use.

The fees prescribed in the Regulations are revised on an annual basis and based on an assessment of the costs associated with a range of licensing requirements and functions. The fee amounts specified in these Regulations are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 19th October 2012. A summary of the consultation responses is published on the MHRA's website (www.mhra.gov.uk).

In general these Regulations provide for an increase in all medicines fees to reflect the higher costs for the MHRA in carrying out related regulatory activities. They also include consequential amendments arising out of the making of the Human Medicines Regulations 2012, some simplification measures, provisions to implement the fees necessary to carry out regulatory activities in relation to brokers of medicinal products, the import, manufacture or wholesale active substances and pharmacovigilance service providers.

Parts 2 to 9 and 11 and 12 and Schedules 2 and 3 provide for capital fees to be payable in connection with pre-application meetings; applications for, or variations to, authorisations, manufacturer's licences, wholesale dealer's licences, clinical trial authorisations, broker's registrations, active substance registrations, traditional herbal registrations and certificates permitting the export of medicinal products; assistance in obtaining or renewing marketing authorisations 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 2012 Regulations (as amended).

However, these Regulations also—

(a)

provide new fees in relation to brokers of medicinal products and persons who import, manufacture or distribute an active substance;

(b)

provide new fees in relation to persons who provide a pharmacovigilance service;

(c)

simplify the fees payable for clinical trial authorisations;

(d)

reduce the fees payable by new manufacturers of simple substances that also serve as active pharmaceutical ingredients;

(e)

make minor technical changes to variations of marketing authorisations implementing Commission Regulation (EC) No 1234/2008 as amended by Commission Regulation (EC) No 712/2012.

Part 10 and Schedule 4 provide for periodic fees in connection with authorisations, registrations and licences.

Part 13 and Schedule 5 provides for fees in relation to homoeopathic medicinal products.

Part 14 and Schedules 6, 7 and 8 deal with the time for payment and waiver or refund of both capital and periodic fees in specified circumstances. Schedules 6 and 7 now also apply to applications for a broker's registration or an active substance registration.

Part 15 makes consequential amendments to the Clinical Trials Regulations to update cross-references to these Regulations.

Part 16 of these Regulations revokes and makes savings provisions in relation to earlier Regulations relating to fees for medicinal products for human use and medical devices for human use.

An impact assessment has not been prepared for this instrument as no impact on the private or voluntary sector is foreseen.