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Fee Reductions/Deferrals SME applicants wishing to request a fee reduction and/or deferral should address a letter of intent to the SME Office (see below) of the EMA.
It should be noted that fee reductions and deferrals can only be considered once the applicant has been assigned SME status by the EMA and are subject to the SME status remaining valid at the time that their application or request is validated by the Agency.
This section provides useful information on how to request SME status, and provides a link to useful information sources (e.g.
the User Guide for Micro, Small and Medium-sized Enterprises (SMEs) on the administrative and procedural aspects of the provisions, laid down in Regulation (EC) No 726/2004, that are of particular relevance to SMEs).
References Incentives and assistance are available from EMA for SMEs, which focus on reducing financial and administrative entry hurdles for SMEs in pre-marketing authorisation procedures such as scientific advice, the application for marketing authorisation and inspections.
These include: In determining which companies are eligible for SME incentives, EMA applies the EU-definition of micro, small and medium-sized enterprises provided in Commission Recommendation 2003/361/EC.
The office aims to facilitate communication with SMEs through dedicated personnel within the agency who will respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs.Scientific guidelines related to quality, safety and efficacy are available, together with concept papers, draft guidelines and overviews of comments received during the consultation on draft versions.The Agency also publishes procedural and technical guidance and document templates, which are intended to provide technical and procedural advice to applicants for marketing authorisations for medicinal products coming within the scope of the centralised procedure, in particular: The marketing-authorisation holder (MAH) is the person who holds the authorisation to place a medicinal product on the market and is legally responsible for marketing the medicinal product.This proof of establishment should be included in annex 5.3 of the application form.It should be emphasised that while the MAH may delegate certain activities to third parties, the MAH remains responsible for assuring all the obligations imposed on MAHs by the European legislation and by national law, as applicable.