The comprehensive EU legislation harmonises the requirements posed on marketing authorisations. The marketing authorisation may apply to the entire EU or EEA or to certain Member States only. The Finnish marketing authorisation requirements and provisions are contained in the Medicines Act.
In individual cases only and for particular therapeutic reasons, Fimea can grant a special authorisation for medicines with no marketing authorisation.
Why does a medicine need a marketing authorisation?
Although the medicine has a positive impact on the human body, it normally also influences organs other than its actual target cell. Adverse reactions may be caused.
In order for a medicine to have the marketing authorisation, its benefits must exceed its risks. The risk-benefit ratio varies according to the ailment or disease targeted at.
In other words, the medicine must be rational. To get the marketing authorisation, the pharmaceutical company must also demonstrate that the medicine is of high quality, efficient and safe.
In addition, the pharmaceutical company must produce a high-quality package for the medicine as well as the package leaflet that provides the medicine user with the necessary information. There are strict regulations covering these texts.
How to obtain a marketing authorisation?
It is possible to apply for a centralised marketing authorisation for a medicine, comprising the entire EU area, EEA countries included. In alternative, the application can be made for one Member State through the respective national procedure, or for several Member States through the mutual recognition or decentralised procedure.
It is partly to the pharmaceutical company to decide for which countries it is going to apply the marketing authorisation. However, the EU legislation includes strict provisions on which medicines require a centralised authorisation. All novel and innovative medicines require a marketing authorisation comprising the entire EU.
Marketing authorisation procedures
The European Medicines Agency (EMA) coordinates the centralised marketing authorisation procedure. In its examination work, EMA refers to the experts of the national regulatory authorities. EMA’s scientific committees issue an opinion on the marketing authorisation. Officially, the comprehensive EU marketing authorisation is granted by the EU Commission.
A purely national marketing authorisation applicable to one Member State only is today a rare phenomenon.
The EU regulatory medicines authorities use two marketing authorisation procedures to avoid overlapping work in the Member States. The principle is that one Member State is a “reference country” that examines the application of the other participating Member States.
In the mutual recognition procedure, the participating Member States recognise the national marketing authorisation previously granted by the reference country.
The marketing authorisation can be issued in the decentralised procedure if no authorisation has previously been issued in any EU Member State. Here, one Member State starts the marketing authorisation evaluation, while the other participating countries participate prior to the granting of the marketing authorisation.
Pharmaceutical development continues after issue of marketing authorisation
The medicine’s development does not end with the issuance of the marketing authorisation. Pharmaceutical companies continue the investigations on their medicinal products, gathering information on their benefits and adverse features. The pharmaceutical companies are obliged to produce updated information for the authorities and the medicine users.
When changes are made in the medicines, a new marketing authorisation must be applied for, following the authorisation process.