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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).
Companies are classified according to their size (micro, small or medium):and according to their category (autonomous, partner or linked).
Depending on the category in which the enterprise fits, some or all of the headcount and financial data from other partner or linked enterprises may need to be counted when calculating whether the SME criteria are met.
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.
A proof of establishment from the applicant company is required by the Agency in order for an application to be validated (e.g.
in the United Kingdom, a certificate of incorporation issued by the Registrar of Companies, and in France, an extrait du registre du commerce et des sociétés).
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.
These questions and answers (Q&As) provide an overview of the European Medicines Agency’s (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.
This guidance should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants and pre-submission guidance documents.
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Companies or firms formed in accordance with the law of a Member State and having their registered office, central administration or principal place of business within the EEA will be treated in the same way as natural persons who are nationals of Member States.