Get Process For Authorising Treatment

The European Medicines Agency (EMA) is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines. The EMA serves the EU and three countries from the EEA—Iceland, Norway, and Liechtenstein.

Authorisation procedures - National authorisation procedures The mutual recognition procedure, which is applicable to the majority of conventional medicinal products, is based on the recognition of a pre-existing national marketing authorisation by one or more EU countries.

National authorisation procedures mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries; decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.

European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.

The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life span. EMA has a committee dedicated to the safety of medicines for human use — the Pharmacovigilance Risk Assessment Committee, or PRAC.

Under both the EMEA and the FDA, the drug development process includes preclinical testing; clinical trials with phase 1, 2, and 3 testing; and a final approval procedure. In the United States, an investigational new drug application is filed with the FDA for drugs that appear safe in the preclinical phase.

As per the EU directive, an MRP is assigned a review cycle of ninety (90) days followed by a thirty (30)-day national phase to translate the product information in the regional languages.

Obtaining an EU marketing authorisation, step-by-step Steps prior to submitting an application. Submission of the application. Assessment of the application. European Commission decision on the marketing authorisation. Voluntary sharing of market launch intentions: pilot project.