Marketing authorisation of medicinal products

A medicinal product may only be placed on the market in the European Economic Area (EEA) when a marketing authorisation has been issued. There are four procedures for marketing authorisation.

The European Economic Area (EEA) comprises the 27 EU member states and the three EEA EFTA states Iceland, Liechtenstein and Norway. EFTA is the European Free Trade Association.

These countries have, through the EEA agreement, adopted the complete Community acquis on medicinal products and are consequently parties to the Community procedures. When reference is made to the Member States it should be read to include Iceland, Liechtenstein and Norway.

Harmonised with EU regulation

The EEA Agreement together with the EEA Joint Committee Decisions imply that regulation of pharmaceuticals in Norway is harmonised with EU regulation. Thus, the requirement specifications in Norway are identical to the EU's.

A pharmaceutical company must apply for a marketing authorisation in order to sell its products on the Norwegian market. The application is filed to the Norwegian Medical Products Agency (NoMA).

In order for NoMA to issue a marketing authorisation the applicant is required to document the product's quality, safety and (medical) efficacy. NoMA makes an assessment of whether the benefits exceeds the potential risk from using the product in question. A marketing authorisation will not be issued unless the product has a positive risk-benefit balance.

Extensive documentation is required. When a new active substance is to be approved the documents may weigh a tonne.

The Four Procedures

There are four procedures the applicant may use when applying for marketing authorisation:

The different procedures do not affect the requirements to or contents of the application but they do affect the way the application is handled.

National Procedure

The company can apply to one country only. This is called national procedure. The country receiving the application makes an assessment within a time limit of 210 days. If the application meets the requirements a marketing authorisation is issued. Unless the company wants to market its product in several countries the procedure stops here.

Mutual Recognition Procedure

If the company wishes to extend the marketing authorisation from the national procedure to the other Member States it may do so through a mutual recognition procedure. The company asks the remaining members to recognise the marketing authorisation or assessment from the national procedure. The mutual recognition procedure has a time limit of 90 days.

Decentralised Procedure

Alternatively, the company applies directly to the Member States where it wishes to market its product. The application is filed to each Member State but only one of them will make the assessment (known as the reference Member State). It has 120 days to do so.

The other Member States have 90 days to recognise the marketing authorisation and will do so unless there are grounds for supposing that the authorisation of the medicinal product concerned may present a potential serious risk to public health.

Centralised Procedure

Certain pharmaceuticals need to or may be approved through a centralised procedure. The application is filed to the European Medicines Agency (EMEA). Two Member States are asked by EMEA to make a first assessment of the application. It will then be assessed by the Committee for Medicinal Products for Human Use (CHMP). A centralised procedure has a time limit of 210 days.

Within the EMEA, the CHMP is responsible for preparing the opinion of the EMEA on any question relating to the evaluation of medicinal products for human use. A marketing authorisation granted under the centralised procedure is valid for the entire Community market, which means the medicinal product may be put on the market in all Member States.