Why Is It Necessary To Register A Drug In The EU?

Registration of medicines in the EU is a mandatory procedure when medicines are intended to be marketed in the European Union (EU) and European Economic Area (EEA). The registration of medicines in the EU is managed by the European Medicines Agency (EMA) and the national regulatory authorities of the EU member states.
All medicines must have a Marketing Authorisation (MA) in order to be put on the market legally in the EU. The ultimate purpose of marketing authorisation is to ensure that safe, effective, and high-quality medicines can quickly be made available to citizens across the EU.
Manufacturers outside the EU/EEA will benefit greatly once the product is licensed by the EMA. When your medicines are licensed by the EMA, the likelihood of it being accepted and approved by the Ministry of Health of all countries worldwide is high, with fast procedures, easy distribution and marketing globally.

Validity Of Marketing Authorisation And Follow Up

The MA is renewed after five years on the basis of a re-evaluation of the benefit-risk balance by the Competent Authority of the authorising Member State. Once renewed, the MA is valid for an unlimited period, unless the Competent Authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.

Marketing Authorisation Procedures

There are two ways to obtain an MA: via the Centralised Procedure (CP) or via a non-centralised procedure. The latter includes the Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP), and the National Procedure.
  • The Centralised Procedure (CP):
    Most new medicines take this route. Industry submits a single application to the EMA. If a medicine is approved in this way, a license for marketing the medicine is granted for all EU and EEA countries.
  • Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP):
    Marketing authorisations are applied for in several Member States at the same time, with one country taking the lead as the Reference Member State (RMS). If successful, the medicine is approved for marketing in the RMS and the other involved countries (Concerned Member States, CMSs). Most generic medicines are approved through the DCP.
  • National Procedure:
    Independent national procedures are strictly limited to medicines which are to be authorised and marketed in only one Member State (MS). This procedure is nowadays rarely followed for new products.

Benefits For You

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. When you register for circulation in the EU through Brilitas, with Brilitas SME status, you will receive up to 50% discount on registration fees, assistance with documentation and consultation.