Drug Approvals Rate Remains High
BMI View : While the approval rate for medicines in Finland has remained high in recent years, BMI believes that drugmakers may be faced with an increasingly tough medicines approvals environment in coming years. The government will step up its focus on cost containment within the healthcare sector, which given the challenging state of the economy underpins our view.
Finland has maintained a high approval rate for medicines over the last five years. The Finnish Medicines Agency (Fimea) approved 907 medicines in 2011, a 35% increase over the 668 approved in 2007. BMI notes that this is positive for drugmakers, considering the decline in submitting applications for marketing authorisations from 1,094 in 2007 to 694 in 2011.
|Applications Submitted For Marketing Authorisation|
A new medicinal product can only be launched on the Finnish pharmaceutical market once it has been granted marketing authorisation by the Fimea (a central agency operating under the Ministry of Social Affairs and Health) or the European Commission (EC).
An application for marketing authorisation for a medicinal product may be filed under the mutual recognition, decentralised, centralised or, on certain grounds, the national procedure.
Under the national procedure marketing authorisation applications are processed within 210 days after receipt of the application.
Under the mutual recognition procedure marketing authorisation applications are processed within 90 days of the date of process launch. This is followed by the national phase with a maximum duration of 30 days.
Under the decentralised procedure marketing authorisation applications are processed within 210 days from the date of process launch. This is followed by the national phase with a maximum duration of 30 days.
Under the centralised procedure the processing period is 210 days + the period required for the European Commission's decision-making process.
Applications for marketing authorisations must be submitted using the common EU application form regardless of the procedure applied to the case. Provisions regarding the marketing authorisation application procedure and documents required are laid down in the Medicines Act and Decree, Fimea Regulation 1/2009 Applying for and maintaining a marketing authorisation and registration for a medicinal product, as well as the publication ' The Rules Governing Medicinal Products in the European Union'. The guidelines and statements adopted by the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) must also be taken into consideration
|A High Rate Maintained|
|Applications Approved For Marketing|
Fimea's Other Responsibilities
Under the Medicines Act (395/1987), medicinal products may only be manufactured industrially by medicinal product manufacturers that have acceptable production facilities and equipment, and a licence issued by Fimea.
Wholesale trade in medicinal products is also subject to a licence issued by Fimea.
Fimea monitors compliance with the stockpiling obligation regarding medicinal products. The Act on Compulsory Stockpiling of Medicinal Products (979/2008) applies to medicinal product manufacturers, medicinal product importers, health care units and the National Institute for Health and Welfare.
Fimea also issues licences for pharmacies, hospital pharmacies and dispensaries. It monitors the lawfulness of their activities, the safety of medicinal products manufacture and the marketing of medicinal products.