Title, date Mr. Einar Magnússon Director, Department of Pharmaceutical Affairs Ministry for Health

The Pharmaceutical Act No. 93/1994 – a framework and legal base Technical regulations Implementation of directives Questions on Medicinal Products Problems of the small markets Overview of this presentation

The Icelandic Pharmaceutical Act is a framework and legal base for technical regulations In particular article no. 49 of the act has been useful as a legal base for issuing and publication of EC regulations and directives The Pharmaceutical Act has been changed 29 times since 1994 The structure of the act needs to be revised, some things need to be clarified and some things are missing in particular some definitions. The implementation of the pharmaceutical package from 2004 is ongoing. The Icelandic Pharmaceutical Act No. 93/1994

Marketing authorisations, labelling and package leaflets Advertising Manufacture Importation and wholesaling Parallel import Herbal medicines Homeopathic medicinal products Clinical practice Pharmacies and pharmacy license Dose dispensing Colouring chemicals Narcotics and psychotropic substances Pricing and reimbursement Blood and blood products Etc. Technical regulations on medicinal products

Directive 2001/83/EC on the Community code relating to medicinal products for human use Directive 2001/82/EC on the Community code relating to veterinary medicinal products Iceland should provide information on how these Directives have been implemented with regards to the authorisation of medicinal products to be placed on the market (marketing authorisation), advertising, manufacture, importation, labelling, whole sale distribution, advertising, pharmacovigilance, supervision and sanctions of medicinal product Questions from the Commision on Medicinal products Trasposition tables – Chapter 1

Marketing Authorisation: Regulations concerning marketing authorisations for proprietary medicinal products, their labelling and package leaflets No. 462/2000 and ammandments reg. No. 766/2001, 443/2005, 581/2006, 1251/2008 and 873/2010Regulations concerning marketing authorisations for proprietary medicinal products, their labelling and package leaflets No. 462/2000 Advertising: Regulation on advertising No. 328/1995 and amendment No. 95/2001 Manufacture: Regulation on Manufacture of Medicinal Products No 893/2004 Importation: Regulation on import and wholesaling No. 699/1996 and amendments No. 484/2001 and No. 846/2002 Labelling: Regulation No. 462/2000 Whole sale distribution: Regulation No. 699/1996 Pharmacovigilance: Regulation No. 462/2000 Supervision and sanctions of medicinal product: Chapter XVI, article 47 and article 48 of the Pharmaceutical Act No. 93/1994 Ansvers to Questions from the Commision on Medicinal products Trasposition tables – Chapter 1

Dir. 2000/38/EC Dir. 2001/83/EC Dir. 2001/82/EC Dir. 2003/63/EC Regul. 2309/93/EC Regul. 540/95/EC Regul. 541/95/EC Regul. 542/95/EC Regul. 2141/96/EC Regul. 649/98/EC Regul. 1146/98/EC Regul. 1069/98/EC Regulations concerning marketing authorisations for proprietary medicinal products, their labelling and package leaflets No. 462/2000 Regulations concerning marketing authorisations for proprietary medicinal products, their labelling and package leaflets No. 462/2000 and ammandments reg. No. 766/2001, 443/2005, 581/2006, 1251/2008 and 873/2010 Regul. 141/2000/EC Regul. 847/2000/EC Regul. 1084/2003/EC Regul. 1085/2003/EC Regul. 1647/2003/EC Regul.273/2004/EC Regul.1277/2005 Regul.2049/2005/EC Regul.1950/2006/EC Regul.1394/2007/EC Regul. 1234/2008/EC

Dir. 2004/27/EC Dir. 2004/28/EC (Regul. 726/2004/EC) Revised regulation for MA´s will be issued in December 2010

Dir. 2001/83/EC Regulation on advertising No. 328/1995 and amendment No. 95/2001

Regulation on import and wholesaling No. 699/1996 and amendments No. 484/2001 and No. 846/2002 Dir. 2001/83/EC Dir. 2001/82/EC Regulation on import of medicinal products for personal use No. 212/1998 and amendment No. 230/2001 Dir. 2001/83/EC Regulation on import of homeopathic medicinal products No. Dir. 2001/83/EC Dir. 2001/82/EC Regulations on import and wholesaling

Iceland should provide information on how the following Directives have been implemented Commission Directive 2003/94/EC and Commission Directive 91/412/EEC on good manufacturing practice Directive 2001/20/EC of the European Parliament and of the Council and Commission Directive 2005/28/EC relating to good clinical practice Questions on Medicinal products – Trasposition tables – Chapter 1

Dir. 2001/83/EC Dir. 2001/82/EC Dir. 91/412/EC Dir. 2003/94/EC Dir. 2001/20/EC Regulation on Manufacture of Medicinal Products No 893/2004

Dir. 2005/28/EC Regulation on Manufacture of Medicinal Products No 893/2004 Revised regulation will be issued in Dcember 2010

Dir. 2001/83/EC Dir. 2001/20/EC Regulation on clinical trials No. 443/2004 and amendment No. 907/2004

Commission Directive 2005/28/EC relating to good clinical practice Regulation on clinical trials No. 443/2004 Revised regulation will be issued in December 2010

Common for the small markets (countries with less than 2 m inhabitants) is less access to medicines than on bigger markets and higher prices. The language requirement can in many cases be a barrier for the market in particular for low volume medicines. With a reference to Belgium-Luxemburg Iceland wants to take up the possibility to be closer connected to a bigger market concerning marketing authorisations. Problems of the small markets