Finland

Policy

The Finnish Medicines Agency (FIMEA) is the Finnish national authority for regulating pharmaceuticals, act as a central administrative agency operating under the Ministry of Social Affairs and Health. FIMEA is also responsible to overlook the implementation of Good Laboratory Practice for any non-clinical studies to which the duty was assigned from Valvira on 1 November 2009. In October 2007, The Government of Finland adopted a new development Policy Programme, based on a comprehensive approach to development and covers all policy sectors related to development. Finland has implemented the reformed EU Common Agriculture Policy, which focuses on the establishment of a common organisation of agricultural markets across member countries, which also covers the sector of medicinal plants and herbs. A major new reform of the CAP is currently being prepared for the period after 2013.

Contact

Finnish Medicines Agency (FIMEA)
Address: Mannerheimintie 103b, P.O. Box 55, FI-00301 Helsinki
Microkatu 1, Kuopio
Tel: +358 9 473 341
Fax: +358 9 714 469
Website: http://www.fimea.fi
Ministry of Social Health and Health Address: P.O. Box 33, FI-00023 Government
Telephone +358 9 16001
Fax: -
Website: http://www.stm.fi/en/social_and_health_services/pharmacotherapy
 

Laws & Regulations

Food Supplements are classified as "special products."  Pre-market notification 2 months prior to marketing of food supplements containing vitamin and minerals is to be done with the Finnish National Food Administration.  Supplements containing herbs are either categorized as special products, or as herbal remedies depending on ingredients and claims.  Herbal Remedies must be registered with the National Agency for Medicines.

Depending on claims made, herbs are either sold as special products or herbal remedies.  Herb products claiming mild nutritional benefits can be sold as special products.  Traditional herbs making medicinal claims can be used in combination of up to 3-6 herbs, and must go through a simplified pharmaceutical registration with the national Agency for Medicines.  There is also a negative list of herbs that must go through a full pharmaceutical registration and can only be sold as medicines.  Foods with herbs added are evaluated on a case by case basis and are either classified as special products or as herbal remedies.

Fortified or Functional Foods – Pre-market notification and authorization by the Finnish National Food Agency is necessary for nearly all fortified foods.  Nutrients can only be added to foods that already naturally contain a significant amount of that nutrient, and the nutritional purpose must be justified.

Contact

National Agency
for Medicines
Mannerheimintie 103b
P.O.Box 55
FI-00301 Helsinki
Tel. +358 9 473 341
Fax. +358 9 714 469                      
http://www.nam.fi/english/

http://www.ktl.fi/nutrition/nutrition_policy.html

 

Standards & Guidelines

The Finnish Medicines Agency (FIMEA) is the Finnish national authority for regulating pharmaceuticals, act as a central administrative agency operating under the Ministry of Social Affairs and Health.

FIMEA is also responsible to overlook the implementation of Good Laboratory Practice for any non-clinical studies to which the duty was assigned from Valvira on 1 November 2009. 

According to section 6 of the Medicines Act (395/1987), products are classified into medicinal products or non-medicinal products.

Herbal remedies falls under one of the 3 categories: herbal medicinal product, traditional herbal medicinal product and Homeopathic and anthroposophic preparations.

Manufacturing of herbal remedies must adhere to the GMP as stated in Finish GMP 5/2007 and also honour the information in the European pharmacopoeia. Other guidelines that must be adhered too are the Admin Regulation: Labelling and package leaflets for medicinal products 1/2010 which states the requirements concerning the labelling and package leaflets for medicinal products to comply with the following the European Union regulations and must be read together with the Normative Guideline: Labelling and package leaflets for medicinal products 1/2010.

Nutritional supplements are subjected to the Food Act. These products are monitored by Finnish Food Safety Authority Evira.

Contact

Finnish Medicines Agency (FIMEA)
Address: Mannerheimintie 103b, P.O. Box 55, FI-00301 Helsinki
Microkatu 1, Kuopio
Tel: +358 9 473 341
Fax: +358 9 714 469
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Website:http://www.fimea.fi
Ministry of Social Health and Health
Address: P.O.Box 33, FI-00023 Government
Tel: +358 9 16001
Fax: -
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Website:http://www.stm.fi/en/social_and_health_services/pharmacotherapy