Brilitas was designated as a SME by the EMA in accordance with Commission Recommendation 2003/361/EC. According to Commission Regulation (EC) No 2049/2005, SMEs at EMA will benefit from EMA policies that apply only to SMEs in terms of the payment of fees to, and the receipt of administrative assistance.

One of the key requirements for becoming a SME at EMA is that your business must be established in a member state of the European Union (EU) or the European Economic Area (EEA). If your company is not already legally established in the EU/EEA, don’t worry, we can help you access EMA offers without incurring the cost of establishing a company in the EU/EEA.

Manufacturers outside the EU/EEA will benefit greatly once the product is licensed by the EMA. That product is easily accepted by the Ministries of Health of all countries around the world and has a quick licensing procedure. As a result, that product is easily marketable and distributed globally.

If you want to apply for SME status, we shall:

• Become your EMA point of contact.
  

• Provide you with the necessary documents and records.
  

• Give you pointers on how to get your application approved by the EMA quickly.
  

• Maintain your SME status by applying for an SME on your behalf.
  

If you are still not ready to apply and wish to benefit from EMA, we are ready to become the Authorized Representative for your activities at EMA.

• Scientific advice, Inspection (pre-authorisation), Application for marketing authorisation, Post-authorisation procedures (e.g. variations, extensions), Scientific services. More information about incentive fees, you can be found here.
  

• Optimize your application form to meet EMA’s criteria and requirements soon.
  

• The Brilitas team will assist you in each stage: application preparation, amendments and supplements as required by the SME Office, renewal, and post-registration procedures.