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 interface has the sole remit of providing regulatory, financial and administrative assistance to small pharmaceutical companies.
It was set up by Commission Regulation (EC) No 2049/2005 and promotes innovation and the development of new medicines for human and veterinary use by SMEs.
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 European Economic Area (EEA). For more information, see UK's withdrawal from the EU.
Benefits
Administrative, regulatory and financial support is available to companies assigned SME status by EMA, including:
- direct assistance by phone, email, teleconference or through briefing meetings on regulatory aspects of the pharmaceutical legislation. SMEs receive help on how to navigate the array of services available, support in identifying the most relevant guidance, or advice on regulatory strategy for a product development or authorisation;
- fee exemptions and reductions for pre- and post-authorisation regulatory procedures, including scientific advice, inspections and pharmacovigilance (see overview table below);
- assistance with translations of product information into all official European Union (EU) languages for the purpose of granting an initial marketing authorisation;
- inclusion in an online SME register. The register is an important source of information on EU/European Economic Area-based SMEs involved in the manufacturing, development or marketing of medicines and promotes partnering and networking between SMEs;
- guidance on clinical data publication and a free redaction tool license;
- liaison with academic investigators in paediatric-medicine research through the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA);
- workshops and training sessions
To support SMEs and stakeholders across the EU, an overview of the SME incentives is available in EU official languages. The SME office also provides assistance to SMEs in the official EU languages where applicable.
SME user guide
EMA's SME user guide helps enterprises navigate the regulatory requirements and the 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.
Financial incentives
EMA fee incentives are applied if an enterprise 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 the 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).
Full details of fee determinations, exemptions and payment can be found at Fees payable to the European Medicines Agency.
| Procedure | Fee incentives |
|---|---|
|
|
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)
|
90% fee reduction for non-orphan products |
| 100% fee reduction for designated orphan products | |
| Establishment of maximum residue limits | 90% fee reduction |
| Extension or modification of maximum residue limit for a veterinary medicinal product | 90% 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 |
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 an enterprise 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.
