Introduction of the National Center for Epidemiology (NCE) Hungary

Common sphere of activities from NCE: National Center for Epidemiology (NCE) is member of National Regulatory Authorities (NRA’s) in Europe, recognised by WHO Common sphere of activities from NCE: Vaccination strategy Collection and surveillance of epidemiological data and diseases Reference laboratory function Recognition and identification of epidemics Virology ,Bacteriology, Parasitology - diagnostical activity

NCE is co-authority of National Institute of Pharmacy considering the Activity of the Center for Epidemiology related to batch release of immunologicals NCE is co-authority of National Institute of Pharmacy considering the assessment - of Marketing Authorisation documents of vaccines and other immunologicals (as blood-products), of variations of marketing authorisation documents of vaccines and other immunologicals (as blood-products), of clinical trials documents of vaccines and other immunologicals (as blood-products), summarises the announcements data related to undesirable effects occuring at use of vaccines and other immunologicals (as blood-products) performing laboratory tests - on the basis of the Decree No 11 of 18 November, 2005. of the Minister of Health in with the 95th Act of 2005. on Medicines for Human Use. - in connection with Quality defects of vaccines and other immunologicals (as blood-products) Participation in international studies as OMCL, e.g. viral safety tests on plasma-pools.

NCE is member of OFFICIAL MEDICINES CONTROL LABORATORIES (OMCL) Network. - It issues Official Control Authority of Batch Release (OCABR) for some immunologicals as blood-products and - it recognises Official Control Authority of Batch Release (OCABR) for vaccines in accordance with article 114 of Directive 2001/83/EC, as amended by Directive 2004/27/EC.

Two separated departments of NCE have the above mentioned sphere of activities the Dpt. for Control of Bacterial Vaccines and Sera and the Dpt. for Control of Viral Vaccines

Sphere of activities of Dpt Sphere of activities of Dpt. for Control of Bacterial Vaccines and Sera: Assessment of MA dossiers of immunologicals on request of Authority (National Institute of Pharmacy) Iissue and recognition of OCABR for specific human immunoglobulines and human bacterial or combined vaccines Making tests on marketing authorised vaccine and immunoglobulines on vaccines on request of WHO

The accreditation of Dpt. has already been finished on eight methods (measurement of free formaldehyde/ aluminium content / pH , determination of potency T (in mice) / potency P w (in mice)/ potency D (in guinea pigs) The scope of the applied Quality System : EN ISO/IEC 17025

Participation on inspections as representative / co-authority of authority concerning the implementation of an immunological product, change in manufacturing process related to the immunological product manufacturing authorised in Hungary. These occasions were : WHO visits were: - June 1993., in September 1994. and in january 1998 in Gödöllő at HUMAN Co. Ltd. relating to its export activity. GMP inspections were: - 1992. And 1993 in Gödöllő at HUMAN Co. Ltd. - April 1996. in Gödöllő at HUMAN Co. Ltd. because of Ltd. Biochemical Devision reconstruction April 2005. , in Debrecen, because of production of Lactobacillus vaccine (Gynevac) May 2005. , in Gödöllő at Producer GlaxoSmithKline Biologicals Kft. because of production of DTPw (CSL / Göd)HB / DTPw (CSL / Göd)HB-Hib vaccine

Sphere of activities of Dpt. for Control of Viral Vaccines (1) Assessment of MA dossiers of immunologicals on request of Authority (National Institute of Pharmacy) Recognition of OCABR certificates for human viral vaccines National Batch release of National influenza vaccine National lyssa surveillance Control of the advers events following vaccination

Sphere of activities of Dpt. for Control of Viral Vaccines (2) Making tests - on marketing authorised vaccines, - control of the protection of population against viral deseases (e.g. measles, mumps, rubella, rabies), - assays on lyssa suspected human samples (fluorescence microscope and mouse inoculation tests)

- determination of abnormal toxicity in mice and guinea pigs, The accreditation of Dpt. for Control of Viral vaccines has already been finished on two methods - determination of abnormal toxicity in mice and guinea pigs, - measurement of pH The scope of the applied Quality System : EN ISO/IEC 17025

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