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Subject matter
This Regulation establishes the circumstances in which, by derogation from the relevant provisions of Regulation (EC) No 297/95, micro, small and medium-sized enterprises (SMEs) may pay reduced fees, defer payment of fees, or receive administrative assistance when submitting applications under Regulation (EC) No 726/2004 to the European Medicines Agency, hereinafter ‘the Agency’.
Scope
1. This Regulation shall apply to SMEs within the meaning of Recommendation 2003/361/EC in the version of 6 May 2003 which are established in the Community. 2. Unless otherwise specified, this Regulation shall apply both to applications concerning medicinal products for human use and to applications concerning veterinary medicinal products, within the meaning of Directives 2001/83/EC ( 5 ) and 2001/82/EC ( 6 ) of the European Parliament and of the Council respectively.
Definition
For the purposes of this Regulation, applicant means an undertaking seeking to benefit from the application of the provisions laid down in Chapters II and III.
Submission of information
An SME wishing to benefit from the provisions of this Regulation shall submit to the Agency the information necessary to demonstrate compliance with the criteria mentioned in Article 2(1).
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