Applying for SME status

Companies can apply to be registered as a micro, small and medium-sized enterprise (SME) by the European Medicines Agency (EMA) if they meet the definition of an SME (SME criteria). This enables them to benefit from fee incentives and other support from EMA.

SME criteria

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

  • the enterprise's size:
    • fewer than 250 employees;
    • 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 European Commission 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, select the 'submit by email' button on the last page of the form, and send it to sme@ema.europa.eu. 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.

Note: This declaration form needs to be opened with a PDF reader. EMA advises to save the document first, and then open with a PDF reader, such as Acrobat Reader.

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 European Union/European Economic Area (EU/EEA), for example inclusion in a commercial register as a permanent legal structure, such as:
  • a 'K-bis' document from the Registre du commerce et des sociétés for France;
  • a 'Handelsregisterauszug' for Germany;
  • a CRO certificate from the Companies Registration Office for Ireland;
  • an 'uittreksel Handelsregister Kamer van Koophandel ' for the Netherlands.
  • a chart of the ownership structure of the applicant, including where applicable its parent and any other partner or linked entities;
  • 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 applicant, including where applicable its parent and any other partner or linked entity.

Languages for submission:

  • 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 assigned SME status will expire two years after the date of closure of the accounts on which the declaration was based.

To renew their SME status, companies should complete the form below, declaring that the enterprise qualifies as a micro, small or medium-sized enterprise (SME), based on the latest approved accounts.

To submit the form, select 'submit by email' on the last page, and send it to smerenewals@ema.europa.eu. The sender will receive automated confirmation of receipt of the email.

Note: This declaration form needs to be opened with a PDF reader. EMA advises to save the document first, then use a PDF reader, such as Acrobat Reader, to open the form.

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 declaration was based on a bona fide estimate of the headcount and financial data (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 declaration.

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

EMA 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 company 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 European Union (EU) or in the European Economic Area (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 EMA's SME office.

Further information can be found in EMA's SME user guide.

Inclusion in EMA's public SME register

Registered SMEs are included in an online SME register. This register is a public source of information on EU and EEA-based SMEs involved in manufacturing, development or marketing of medicines for human or veterinary use. 

It aims to facilitate and promote interaction, partnering and networking between SMEs.

The register allows users to search registered SMEs by, for example, name, field of activity, sector and country.

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