National agency fees: charges by national competent authorities

Nothing in Directive 2001/83/EC harmonises what national competent authorities charge. Each Member State sets its fees in national law or a fee ordinance, so the cost of the same procedure differs widely between, for example, Germany, France, Spain and the smaller markets. Fees exist for national applications, for acting as reference member state or concerned member state in a decentralised or mutual recognition procedure, for repeat-use procedures, for Type IA, IB and II variations, for grouped variations and worksharing, for renewals, for Article 61(3) notifications in some countries, for transfers and for scientific advice. Most authorities also charge an annual fee per authorisation, sometimes per strength or presentation, which continues for as long as the authorisation exists whether or not the product is marketed.

The structure matters as much as the amount. Some authorities charge per authorisation, some per procedure, and some reduce the fee when several products or strengths are filed together. Reference member state fees are higher than concerned member state fees because the RMS does the assessment. Several countries also levy taxes or contributions that are not fees in the formal sense, such as a percentage of sales to fund the authority or the health system, and these appear in the overall cost of a market even though they are not paid to regulatory affairs. Fees change with national budget cycles, usually at the start of a year, and are published by the authority, not by EMA.

What goes wrong: a decentralised procedure is costed with the RMS fee only, leaving out ten concerned member state fees and ten annual fees; annual fees keep running on dormant authorisations that should have been withdrawn; a repeat-use procedure is launched without checking that the target markets' fees justify the expected sales; the fee for a grouped variation is assumed to be one fee when the authority charges per change; and a transfer leaves the old holder paying annual fees until the national register is updated. Because the figures sit in dozens of national documents in as many languages, keeping them current is work in itself, and most companies discover a changed fee only when the invoice arrives.