There are mainly four procedures by which an applicant can obtained a marketing authorization in EU
This procedure allows applicants to obtain marketing authorization for all markets within the European Union by single application.
By this procedure applicants needs to make the applications directly to the European Medicines Agency (the “EMA”)
Applications are scientifically evaluated by the appropriate EMA committee e.g. Committee for Medicines for Human Use mostly for human medicines.
The centralized procedure is set out in Regulation (EC) 726/2004.
Since 2008, the centralised procedure is compulsory for:
Biotechnology-derived products and products used for treating Acquired Immune Deficiency Syndrome (AIDS), auto-immune and viral diseases, cancer, neuro-degenerative disorders; diabetes as well as rare diseases (orphan drugs).
Mutual Recognition Procedure
The mutual recognition procedure is applicable if applicant has already received a Marketing Authorization (MA) in any MS at the time of application for the intended medicinal product and applying for more than one member state.
In mutual recognition procedure, one member state (the “Reference Member State”) will decide to evaluate the medicinal product, at that time other member states (the “Concerned Member States”) suspend their own evaluations and wait for the Reference Member State’s decision on the medicinal product.
If the Reference Member State’s decision is favorable, a report is communicated to the Concerned Member States, who must then each recognize the Reference Member State’s decision and at the end of a MRP, national licenses are issued in the CMSs involved in the procedure.
The MRP is based on the idea that a national license approved in one EU Member State (Reference Member State-RMS) should be mutually recognized in other EU countries (Concerned Member States-CMS). This is based on the assumption that the evaluation criteria in the EU member states are sufficiently harmonized and are of the same standard.
Decentralised Procedure,” was introduced with the newly revised EU pharmaceutical Directive 2004/27/EC in November 2005.
This procedure is applicable in cases where a marketing authorisation does not yet exist in any of the EU member state at the time of application.
The procedure is similar to the mutual recognition procedure and relies on the recognition by national authorities of a first assessment performed in one Member State.
Identical dossiers are submitted in all Member State where a marketing authorisation is wanted.
National procedure can be used if applicant wants Marketing Authorisation (MA) to market a product in an individual EU member state.
As applicant has options of Centralised and Decentralised Procedures, which allow Marketing Authorisation (MA) across the EU member state, the number of national submissions has declined over the years.
However there are certain reasons where applicant can go for National procedure:
If applicant wants to:
- Launch in one market only (smaller/local companies)
- ‘Test the market’ in one country only before going for Mutual Recognition
- Launch a niche product for a particular member state
- Sort out contentious issues that might come up during assessment
- Prompt an overseas site inspection (e.g. GMP inspection of a manufacturing site)
Types of application
Depending on the nature of the active ingredient of the product, there are different types of application:
(IN US market, these applications are call New Drug Applications: NDA)
Full Applications are required for new active substances.
Full applications must have a dossier of information which includes all information relating to pharmaceutical tests, preclinical tests and clinical trials.
(IN US market, these applications are call Abbreviated New Drug Applications: ANDA)
Abridged applications can be used when medicines containing an active substance which is already received marketing authorization.
The purpose of these abridged applications is to avoid the need to unnecessarily repeat the tests and trials of the product if the same or a similar product has already received marketing authorisation.
Abridged applications can be used for:
existing drugs with new forms, routes to administration or indication;
existing drugs in new combinations;
well established drugs and products; and
Informed consent and change of ownership applications where, for commercial reasons, a company wishes to make a duplicate of a marketing authorization.
European Union (EU) is a family of political and economic union of 28 member states (MS):
There are five EU institutions, each playing a specific role:
- European Parliament (elected by the peoples of the Member States);
- Council of the European Union (representing the governments of the Member States);
- European Commission (driving force and executive body);
- Court of Justice (ensuring compliance with the law);
- Court of Auditors (controlling sound and lawful management of the EU budget).
An extensive amount of effort was spent by the EU Commission, the EU parliament, the EMEA and the national authorities in updating the EU regulatory environment for pharmaceuticals and granting marketing authorisations within the EU.
Role of EMEA:
The European Agency for the Evaluation of Medicinal Products (EMEA) is primarily responsible for the scientific evaluation of applications for a European marketing authorization for medicinal products derived from biotechnology and other high technology (centralized procedure).
The European Medicines Agency’s (EMA) main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.