1. Introduction of the National Center for Epidemiology (NCE) Hungary

2. 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

3. 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, of the
Minister of Health in with the 95th Act of 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.

4. 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.

5. 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

6. 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

7. 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

8. 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 and in january 1998 in Gödöllő at HUMAN Co. Ltd. relating to
its export activity.
GMP inspections were:
And 1993 in Gödöllő at HUMAN Co. Ltd.
- April in Gödöllő at HUMAN Co. Ltd. because of Ltd. Biochemical Devision
reconstruction
April , in Debrecen, because of production of Lactobacillus vaccine (Gynevac)
May , in Gödöllő at Producer GlaxoSmithKline Biologicals Kft. because of production of DTPw (CSL / Göd)HB / DTPw (CSL / Göd)HB-Hib vaccine

9. 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

10. 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)

11. - 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

12. Thank you for your attention