Applying for SME status

This content applies to human and veterinary medicines.

Enterprises should apply for SME status before requesting financial or administrative assistance from the Agency. To be eligible, companies must be established in the European Union (EU)/European Economic Area (EEA) and meet the definition of an SME.

United Kingdom's (UK) withdrawal from the EU

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the EEA. For more information, see UK's withdrawal from the EU.

The SME criteria are set out in Commission Recommendation 2003/361/EC and are based on the following factors:

  • the enterprise's size:
    • fewer than 250 employees and;
    • either an annual turnover of not more than €50 million or an annual balance-sheet total of not more than €43 million.
  • the ownership structure, including any partnership or linkage. Types of enterprises (autonomous, partner, linked) correspond to relationships that enterprises could have with one another, and which may impact on the overall headcount and financial criteria of an enterprise.

Further information on how to determine whether an enterprise can qualify as an SME can be found in the EC user guide to the SME definition.

Applying for SME status for the first time

To apply for SME status, enterprises should complete the electronic declaration form and send it by clicking the 'submit by email' button on the last page of the form. A signed and scanned version must also be submitted in PDF format and this can be attached to the same email, along with supporting documentation. The sender will receive automated confirmation of receipt of the email.

The declaration form automatically calculates headcount, annual turnover and balance-sheet total in line with the ownership structure of the enterprise. It can only be sent once all mandatory fields (highlighted in red) have been completed.

The applicant should also send:

  • the most recent annual accounts (audited, if possible) for the applicant enterprise and, if applicable, those of any partner or linked enterprises to support the figures provided;
    • if the applicant enterprise is newly established and annual accounts are not yet available, a realistic bona fide estimate of the relevant data for the financial year should be provided in the declaration;
  • proof of establishment of the company in the EU/EEA, for example inclusion in a commercial register as a permanent legal structure, such as:
  • a Handelsregisterauszug for Germany;
  • a 'K-bis' document from the Registre du commerce et des sociétés for France;
  • a certificate of incorporation at Companies House for the United Kingdom.
  • a chart of the ownership structure of the applicant, including where applicable its parent and any partner or linked enterprises;
  • the ownership information should include details of the upstream ownership (i.e. key shareholders and their holdings in terms of percentage of capital and voting rights) and the downstream ownership (i.e. participations in other companies in terms of percentage of capital and voting rights) of the enterprise.

Requests for SME status should be submitted in English. Supporting documents such as annual accounts, annual reports or evidence of proof of establishment can be submitted in any official EU language.

After review, the Agency issues an SME number and notifies the applicant that SME status has been assigned. This status is applicable solely for Agency-related activities and does not serve for other national or EU funding programmes.

Renewing SME status

An enterprise's SME status will expire two years after the date of closure of the accounts on which the declaration was based.

To renew the SME status, enterprises should complete an updated (based on the latest approved accounts) and send it to by clicking the 'submit by email' button on the last page of the form. The sender will receive automated confirmation of receipt of the email.

Supporting documents are only needed where one or more of the following applies:

  • a change in type of the enterprise (autonomous, partner, linked) and/or amendments to annex A and/or B of the SME declaration form, resulting from significant changes in the upstream or downstream ownership structure. Examples of significant changes include:
  • acquisition, takeover, merger of the applicant and/or its partner/linked entities,
  • new acquisitions by the applicant and/or its partner/linked entities,
  • liquidations,
  • major changes of shareholders' capitalisation of the applicant and/or its partner/linked entities;
  • SME thresholds exceeded over one accounting period (for more information, refer to Article 4.2 in the annex to Commission Recommendation 2003/361/EC);
  • the company's previous submission was based on a bona fide estimate of the headcount and financial data (because annual accounts were not yet available);
  • the applicant's SME status has expired and there are one or more years of accounting data missing since the last submission.

Supporting documents (such as annual accounts and ownership data) can be submitted in any official EU language.

The Agency reserves the right to request further information from the company to establish that the SME criteria are met and may, at any time, perform audits as part of its SME programme. The SME will be liable to consequences in case of a false declaration.

Enterprises not yet established in the EU/EEA

If an enterprise is not yet legally established in the EU/EEA, SME incentives can be accessed through an EU/EEA-established SME regulatory consultancy. Both the regulatory consultancy and the non-EU/EEA-based company have to be assigned SME status by the EMA SME office.

Further information can be found in the EMA User guide for SMEs.

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