• A Centralised Procedure – with applications made directly to the European Medicines Agency (EMEA) whereby a European marketing authorisation is granted.
• A Mutual Recognition Procedure (MRP) – whereby applications are made to the Member States selected by the applicant and the procedure operates by mutual recognition of national marketing authorisations. In addition, national authorisations are still available for medicinal products to be marketed in only one Member State.
• A Decentralised Procedure (DCP) came into operation in late 2005. It is applicable in cases where an authorisation does not yet exist in any of the Member States. Identical dossiers are submitted in all Member States where a marketing authorisation is sought. A “Reference Member State”, selected by the applicant, will prepare draft assessment documents and send them to the other Member States concerned. They, in turn, will either approve the assessment or the application will continue into arbitration procedures.

Each EU country retains national responsibility for pricing and reimbursement decisions, procedures which can delay the market entry of pharmaceutical products.

Other countries
Most other countries outside the EU have approval processes for drugs that are based on and similar to those in Europe and the US.