Supporting SMEs

This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) addresses the unique needs of micro, small and medium-sized enterprises (SMEs) through the SME office. This dedicated office has the sole remit of providing regulatory, financial and administrative assistance to SMEs who want to develop and market medicines for human or veterinary use in Europe. 

It was set up by Commission Regulation (EC) No 2049/2005 (the SME Regulation) to promote SME-driven innovation and development of new medicines for human and veterinary use.

A report is available from an EMA roundtable with stakeholders on the 15-year anniversary of the SME Regulation in November 2020, where SME stakeholders and regulators discussed the achievements, challenges and opportunities for EU support to SMEs in the pharmaceutical sector.

Findings are also available from the SME Office's 2020 survey of SME experiences with the SME Regulation, EMA's services for SMEs and challenges faced by SMEs, such as regulatory burden and access to finance, to help guide EMA's future support activities.  

For more information:

 

Find out how EMA can help pharmaceutical SMEs by watching this video (2:11 minutes). It is available in English, German, French, Italian, Spanish, Polish and Portuguese.

 

 

Benefits

An overview of SME incentives is available in several official EU languages in the leaflet below. The SME office also assists SMEs in official EU languages where applicable.

SME user guide

EMA's SME user guide helps companies navigate the regulatory requirements and incentives available throughout a medicine's product lifecycle. It provides an overview of procedures to support research and development activities, and improves understanding of what is needed to obtain marketing authorisation

Translation assistance (new)

EMA provides free-of-charge translations of product information in all EU languages for initial EU marketing authorisations (this excludes Icelandic and Norwegian).

EMA provides translation assistance at the time of CHMP/CVMP opinion through the EU Translation Centre (CdT). The national competent authorities verify the quality of translations.

To be eligible, an applicant's SME status must be valid when the process of requesting translations begins.

During the evaluation of a marketing authorisation application, EMA sends procedural details on the translation process to the applicant, who can also contact the SME office for any practical questions.

For access to incentives following mergers, acquisitions or product out-licensing, see sections 2.4.1 and 2.5.3 of the SME user guide. EMA strongly advises companies to contact the SME office to discuss these specific cases.

Financial incentives

EMA fee incentives are applied if a company has been assigned SME status by the Agency.

Companies are advised to register as an SME or renew their status well in advance of a planned regulatory submission to EMA.

Applicants do not need to obtain confirmation of a fee incentive from the Agency. Conditional fee exemptions, where applicable, should be requested at the time of dossier outcome (see below).

ProcedureFee incentives

Scientific advice

 

90% fee reduction for non-orphan products
100% fee reduction for designated orphan products
100% fee reduction for products granted eligibility to PRIME
90% fee reduction for veterinary medicinal products
Inspection (pre-authorisation)90% fee reduction and deferral
100% fee reduction for designated orphan products

Application for marketing authorisation

 

Fee deferral until the outcome of marketing authorisation application (positive, negative or withdrawn application)
Conditional fee exemption, where EMA scientific advice is followed and a marketing authorisation application is not successful
100% fee reduction for designated orphan products

Post-authorisation procedures (e.g. variations, extensions)

 

Fee exemption for micro-sized enterprises
40% fee reduction for small or medium-sized enterprises
100% fee reduction for designated orphan products during the first year after marketing authorisation (reverting to fee incentives according to size thereafter)

Scientific services (e.g. certification, Article 58 procedures and consultation on medical devices)

 

90% fee reduction for non-orphan products
100% fee reduction for designated orphan products
Establishment of maximum residue limits90% fee reduction
Extension or modification of maximum residue limit for a veterinary medicinal product90% fee reduction
Administrative services (excluding parallel distribution)100% fee reduction
Inspection (post-authorisation)90% fee reduction
Pharmacovigilance (see below for more details)Fee exemption for micro-sized enterprises
40% fee reduction for small or medium-sized enterprises

 

Full details of fee determinations, exemptions and payment can be found at Fees payable to the European Medicines Agency. EMA strongly advises companies to contact the SME office to discuss access to incentives following a merger and acquisition or product out licensing. For more information, see sections 2.4.1 and 2.5.3 of the guidance in the SME user guide.

Pharmacovigilance fee incentives

Fee incentives relating to pharmacovigilance activities are applied if an enterprise has been assigned SME status by the Agency, or has submitted a SME declaration or renewal to the Agency. Pharmacovigilance fees will be subject to corrections where a company wrongly claims a fee incentive for pharmacovigilance activities.

Companies are therefore advised to contact the SME office for any question relating to the SME definition prior to formally submitting a SME declaration in relation to pharmacovigilance fees.

For full details on fee determination, payment and fee exemptions and reductions for pharmacovigilance fees, see Pharmacovigilance fees payable to the European Medicines Agency.

Medical Dictionary for Regulatory Activities (MedDRA) fee waiver

For details about fee waivers applicable to MedDRA subscriptions for micro and small sized enterprises, see EudraVigilance system overview and MedDRA's website.

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