European Medicines Agency - Regulatory - Regulation of medicines


The European Medicines Agency launched in 2010, a public register of SMEs to provide information on companies, which are registered with the Agency. The aim is to address the increasing demand for information from SMEs, their stakeholders and National Competent Authorities and to provide more openness and transparency on this important activity undertaken by the Agency to support innovation.


The Agency’s SME Public Register has been created, in consultation with SME stakeholders, with the following objectives:

      a) To facilitate and promote interaction, partnering and networking between SMEs,
      b) To increase information available to SMEs and their stakeholders,
      c) To provide a source of information for EU institutions, agencies and Member States.


Scope of the Register

The Register includes companies established in the European Economic Area that have submitted a SME declaration within the meaning of Recommendation 2003/361/EC and to whom the Agency has assigned SME status. (Please refer to Applying for SME Status)


In line with Regulation (EC) No 2049/2005 which aims at supporting the development of new medicinal products by SMEs, the Register focuses on companies which are directly involved in the manufacturing, development, and/or marketing of human and veterinary products. Registered SMEs which do not belong to this category (e.g. R&D contract and consulting services) will be included in the Register under a non searchable listing (cf. List of registered companies).


SME Registration by the Agency does not confer any regulatory review of the company’s development programme, neither does it convey any opinion on the acceptability of a marketing authorisation application or accreditation of a company’s business activity.



1. The SME Register includes information submitted by the companies registered with the SME office. It is the full responsibility of these companies to ensure that the information declared in the Register is accurate. The information will be regularly updated by companies and in particular at the time of renewal of SME status, or upon request at an earlier date.


2. The links to the SMEs websites provided in the Register should not be construed as an endorsement by the Agency of the views contained therein. The Agency is therefore not responsible or liable for the information available on the websites of the registered companies.