Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises Text with EEA relevance
Commission Regulation (EC) No 2049/2005of 15 December 2005laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to European Parliament and Council Regulation (EC) No 726/2004 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines AgencyOJ L 136, 30.4.2004, p. 1., and in particular Article 70(2) thereof,Whereas:(1)Regulation (EC) No 726/2004, which replaces Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal ProductsOJ L 214, 24.8.1993, p. 1., provides that the revenue of the European Medicines Agency (hereinafter referred to as the Agency) must consist of a contribution from the Community and fees paid by companies.(2)In the context of the system established by Regulation (EEC) No 2309/93, Council Regulation (EC) No 297/95OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1). provides for fees payable to the Agency.(3)Pursuant to Regulation (EC) No 726/2004, the situation of micro, small and medium-sized enterprises (SMEs) has to be considered separately. In order to reduce the cost for SMEs of marketing medicinal products authorised via the centralised procedure, that Regulation therefore foresees the adoption of specific provisions allowing a reduction of fees, deferring the payment of fees, and providing administrative assistance. Such provisions should apply equally to the human and veterinary sectors and should aim at promoting innovation and the development of new medicinal products by SMEs.(4)The definition of micro, small and medium-sized enterprises provided in Commission Recommendation 2003/361/ECOJ L 124, 20.5.2003, p. 36. should apply, for reasons of coherence and transparency.(5)Experience gained since the adoption of Regulation (EEC) No 2309/93 shows that the main financial and administrative entry hurdles for SMEs are the various steps involved in pre-marketing authorisation procedures, such as the seeking of scientific advice, the submission of the marketing authorisation application, and the undergoing of inspections. Provisions laid down in this Regulation should therefore be focused on these aspects.(6)The fees for the marketing authorisation application and the related inspections conducted for the purpose of assessing the application could constitute a significant financial constraint for SMEs. Consequently, in order to avoid a weakening of the financial situation of undertakings during the assessment of the marketing authorisation application, it is appropriate to defer the payment of these fees until the end of the procedure.(7)SMEs operating in the pharmaceutical sector are often innovative companies, such as those active in the fields of gene or somatic cell therapy, which can notably benefit from the pooling of scientific expertise at a Community level. Furthermore, the scientific evaluation of a marketing authorisation application is more likely to be favourable in the case of medicinal products which have obtained scientific advice. Therefore, access to the Agency’s scientific advice for SMEs seeking marketing authorisation should be facilitated through fee reductions. As an additional incentive, a conditional fee exemption should be given to applicants who have requested such advice and who have actually taken it into account for the development of their medicinal product.(8)Another incentive should also be provided, in the form of a fee reduction, for the establishment of maximum residue limits (MRL) for veterinary medicinal products in order to further support the establishment of such limits.(9)Translations can constitute a significant administrative burden for SMEs. The Agency should therefore make appropriate arrangements to provide for the translations of certain documents required for the granting of marketing authorisation, in particular the draft summary of the product characteristics and the draft text of the labelling and package leaflet.(10)A lack of experience with the centralised procedure and the Agency as an administrative organisation should not impair the development and marketing of new medicinal products. Consequently, it is appropriate to create an SME office, with the sole remit of offering administrative assistance to SMEs. The SME office should provide a single interface between the applicant SME and the Agency, so as to facilitate communication and to answer practical or procedural enquiries.(11)In order to provide practical guidance to applicant SMEs, the Agency should publish a user guide on the administrative and procedural aspects linked to the centralised procedure which are of particular relevance for SMEs.(12)The Agency should report annually on the operation of the provisions laid down in this Regulation, so that feedback on their practical application is available.(13)In order to ensure that SMEs benefit, to the largest extent possible, from the derogation provided for in this Regulation it should enter into force immediately.(14)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use and of the Standing Committee for Veterinary Medicinal Products,HAS ADOPTED THIS REGULATION: