Accession Preparation: Situation in Croatia Siniša Tomi ć , PhD, Associate Professor Head of the Agency for Medicinal Products and Medical Devices (HALMED), Croatia
Content: • Croatian Agency for Medicinal Products and Medical Devices (HALMED) • Role of HALMED • Harmonisation of legislation with the acqui (Brief history of Croatian regulatory framework) • Twinning Light Project • HALMED’s achievements and challenges • Conference Announcements
National regulatory authority Provides services pertaining to human medicinal products, medical devices and homeopathic products in accordance with the Croatian legislation Established on October 1, 2003 Legal compliance is supervised by the Ministry of Health and Social Welfare Generates its own income through service fees and annual charge
130 employees, 2011 74 employees, 2003
Collaborates with various international institutions: …and Medicines agencies of the EU member states: Twinning Light Project …as well as Medicines agencies in the region: … and last, observer to :
CO-OPERATION WITH EMA IPA Programme 2009-2011 EMA Albania EMA Albania Croatia Croatia Bosnia and Bosnia and Hercegovina Hercegovina Macedonia Macedonia IPA IPA Kosovo under UNSC Kosovo under UNSC Resolution 1244/99 Turkey Resolution 1244/99 Turkey Serbia Serbia Montenegro Montenegro Legend: EMA European Medicines Agency IPA Instrument for Pre-Accession Source: S. Tomic et al., Regul Toxicol Pharmacol 57 (2010) 325-332.
HALMED’S KEY ROLE Protecting public health by ensuring safety, quality and efficacy of medicines Quality Efficacy Safety Promotes public health by helping people to understand the risks and benefits of the medicines they use
www.halmed.hr Safeguard public health by carrying out its com m unication role through provisions of accurate, scientifically proved and tim ely inform ation on m edicinal products and m edical devices to healthcare professionals, patients and the general public
www.halmed.hr New Safety Information
www.halmed.hr Dear Healthcare Professional Letter
HARMONISATION ARMONISATION H WITH THE EU EU LEGISLATION LEGISLATION WITH THE • acquis communautaire • negotiation procedure between Croatia and the EU: Chapter 1 “Free Movement of Goods” which defines regulation of medicines and medical devices was closed in April 2010 • continuous monitoring and harmonisation of Croatian legislation with the aquis
HISTORY OF REGULATORY FRAMEWORK IN CROATIA Medicinal Products roducts Act Medicinal P Act Act on (2007/amend. 2009) Act on Medicinal Products Medicinal Products and and Medical Devices, 2003 Medical Ordinance on monitoring Ordinance on Special Ordinance on Special Devices, 1997 Conditions for EU Conditions for EU of quality defects, 2005 Authorised Authorised MP MP ( (2008 2008) ) Ordinance Ordinance on GMP, 2009 on GDP, 2005 Ordinance on Advertising MP, HP and MD, 2005 Ordinance on Advertising of MP&HP, 2009 Ordinance on Bioequivalence, 1999 Ordinance on Ordinance on Drug consumption GLP, 2006 reporting, 2005 Medical al Devices Devices Act Act Medic Ordinance on PHV, 2009 (2008) (2008) Ordinance on Clinical Ordinance on Quality testing, 2005 Ordinance on the the Procedure Ordinance on Procedure trials and GCP, 2010 for for Granting M Granting MA A (2008/amend. ( in 2009) Ordinance on Marketing, labelling and advertising of THMP, 2010
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