Title, date

Mr. Einar MagnússonDirector, 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 873/2010Advertising: 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

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/ECDir. 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 893/2004Revised 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