EMEA public statement on fee reductions for designated orphan medicinal products

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Orphan medicinal products designated in accordance with Regulation (EC) No 141/2000 of 22 January 2000, are eligible for fee reductions for all fees payable under Community rules pursuant to Regulation (EEC) 2309/93, as amended. This includes fees for pre-authorisation activities such as protocol assistance (scientific advice), and for products using the centralised procedure: the application for marketing authorisation, inspections and post-authorisation activities such as variations, annual fees, etc.

With effect from 2007, the fee reduction policy for designated orphan medicinal products has been revised to re-focus this important incentive in the pre-authorisation phase. Once products are authorised the financial support from the Agency will be limited, except where the holder of the marketing authorisation is a micro, small and medium-sized enterprise (SME).

In the revised policy for 2007, the 100 % fee reduction for protocol assistance and 50% reduction for the application for marketing authorisation and 100% fee reduction for pre-authorisation inspections are maintained.

Following the grant of the marketing authorisation, the level of benefit in the form of 50% fee reductions has been limited to SMEs the first year after granting a marketing authorisation. This is in line with Regulation (EC) No 726/2004 of 31 March 2004 and the Commission Regulation (EC) No 2049/2005 on SMEs, where support in the post-authorisation phase is deemed necessary.

Fee exemptions for 2007

The funds made available by the Community for fee exemptions for orphan medicinal products amount to € 6 000 000 in 2007.

Subject to the availability of funds, the following level of fee reductions has been agreed by the Executive Director of the EMEA and shall take effect on 1 January 2007:

  • Full (100%) reduction for protocol assistance and follow-up
  • Full (100%) reduction for pre-authorisation inspections
  • 50% reduction for new applications for marketing authorisation
  • 50% reduction for post authorisation activities including annual fees apply only to small and medium sized enterprises1 in the first year after granting a marketing authorisation

How to request a fee reduction: submission of a letter of intent to obtain a fee reduction

Sponsors of orphan medicinal products wishing to request a fee reduction should address a letter of intent to obtain a fee reduction to the EMEA, to the attention of:
Dr Agnès Saint Raymond,
Head of Scientific Advice and Orphan Drug Sector

It should be noted that fee reductions can only be considered once the decision on orphan medicinal product designation has been granted by the European Commission. In addition, the application should fall within the scope of the orphan condition. The applicant or marketing authorisation holder requesting the fee reduction must be the sponsor of the designation. If this is not the case, the sponsorship of the designation should be transferred prior to submitting the request.

The letter of intent to request a fee reduction should be received by the EMEA not more than 2 months and not less than 2 weeks prior to the planned protocol assistance/centralised application/variation. For inspections, the letter requesting a fee reduction should be sent out as soon as the CHMP inspection request is issued. Further information on how to submit a letter of intent for an Orphan Medicinal Product application to obtain a fee reduction is provided in Annex I.

To be eligible for fee reductions on Post-Authorisation a in the first year after granting a marketing authorisation the sponsor will need to meet the definition of SME as defined in Commission Recommendation 2003/361/EC of 6 May 2003. It should be noted that fee reductions can only be considered once the applicant has been assigned SME status by the EMEA2.

Please note that only SME marketing authorisation holders will be eligible to request reduction of the first year annual fee. A letter of intent for fee reduction for the first year annual fee should be sent to the EMEA once SME status has been assigned.

For orphan medicinal products authorised via the mutual recognition procedure, the national competent authorities in Member States may offer fee reductions for orphan medicinal products. Further information is available in the 'Inventory of Community and National Incentive Measures to Aid the Research, Marketing, Development and Availability of Orphan Medicinal Products', which is available on the European Commission website.


1 An SME is defined according to Commission Recommendation 2003/361/EC of 6 May 2003.
2 Information on how to be assigned SME status is available on the EMEA web-site.

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