A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday, 5 March 2010

UK medicines fees change from 1 April

The Medicines (Products for Human Use) (Fees) Regulations 2010, 2010 No. 551, were laid before the British Parliament yesterday and, assuming nothing goes wrong, will become law on 1 April. These Regulations revoke and re-enact in consolidated form, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2009 as amended by the Medicines (Products for Human Use) (Amendments relating to Fees for Variations) Regulations 2009 and govern 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.

You might be forgiven for not spotting it, but there's a tiny reference to paediatric extensions and supplementary protection certificates hidden away in paragraph 10(4) of Schedule V ("Waiver, Reduction or Refund of Capital Fees"). You can spend the first half of your weekend looking for it and the second half wondering what it all means ...

1 comment:

Anonymous said...

Would have been nice if this consolidated version would also refer to the consolidated version of the SPC regulation, i.e. 469/2009 and not 1768/92.