Regulatory Focus™ > News Articles > EMA Updates Its Fee Structure Guidance

EMA Updates Its Fee Structure Guidance

Posted 13 September 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has released a revised set of rules regarding the fees payable to the agency for the submission of medicinal products and the maintenance of regulatory activities.

The rules, released 24 August 2012, include four primary revisions to the existing version, said EMA.

The first is a clarification regarding the definition of type II quality variations. Type II variations are defined by EMA as "major variations" that are likely to have a significant effect on the quality, safety or efficacy of the product.

The new definition now includes non-clinical data for basic fees. "For a quality variation for which no clinical or non-clinical data are submitted or no cross-references to previously submitted clinical data are made available by the marketing authorization holder," sponsors will be responsible for a fee of €60,200, EMA explained. Veterinary products, meanwhile, will only need to pay €30,100.

The second change to the document involves the addition of a new chapter on fee determination and payment, including when fees are due, when invoices must be received, deadlines for payment, the deferment of fees, exemption of fees and how to request a reduction in fees.

The third and fourth changes are relatively minor, and involve the addition of a reference to an existing regulation within a subsection and the correction of a guideline reference.

The rules come into effect immediately.


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