Safety of medicines
The safety of medicinal products
All medicines marketed and used in Finland must have a marketing authorisation or a registration. The marketing authorisation is granted by Fimea or the European Commission. The registration is granted by Fimea.
A pharmaceutical company must apply for the marketing authorisation themselves. Based on the information entered in the application, Fimea verifies that the medicinal preparation meets the requirements for efficacy, safety and quality. In individual cases where special therapy reasons so require, Fimea can grant a special permission for compassionate use that does not have a marketing authorisation.
Finnish customers purchase their medicines in a pharmacy.
Nicotine replacement therapy preparations, herbal preparations and homeopathic preparations can be purchased in other places too, unless their sale is restricted to pharmacies as a condition for registration.
Pharmacies and hospital pharmacies purchase their medicines from pharmaceutical distributors who only sell medicinal preparations they have procured from the respective manufacturer or its authorised importer.
The Finnish Medicines Agency Fimea grants operating licences to pharmaceutical manufacturers and supervises the operations of pharmacies, pharmaceutical distributors and pharmaceutical manufacturers.
Regulation of medicinal preparations consists of pre-marketing control and post-marketing control
A medicinal preparation is carefully examined before it is marketed, and its safety is monitored also when the preparation is on the market. Pre-marketing control takes place before a marketing authorisation or registration is granted and post-marketing control takes place after the marketing authorisation or registration has been granted.
The purpose of pre-marketing control is to ensure that the benefits of the medicine are greater than its adverse effects or risks. The purpose of post-marketing control is to obtain additional information on the safety of the medicine.
A medicine that has been granted a marketing authorisation has been studied in controlled circumstances on a few thousand patients at most. In real life, the medicine is used by a much larger and diverse group of patients. They might have other illnesses or use other medicines whose interactions with the new medicine are not necessarily known yet.
Moreover, rare adverse reactions might not become apparent before the drug has been used by a large number of people. This is why it is extremely important to monitor the safety of medicines also after the marketing authorisation has been granted.