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Introduction of the unit of Quality Control for Immunobiologicals


The legal background for the National Centre for Epidemiology (NCE) to act as a co-authority:

NCE has applied the Article 114 of the Directive 2001/83/EC amended by 2004/27/EC for blood and plasma derivatives and vaccines in accordance with the Act 95th of 2005 on Medicines for Human Use and Decree No. 18 of November 2005 of the Minister of the Health. As a co-authority without authority rights, NCE collaborates with the National Authority (National Institute of Pharmacy) for the registration and control of immunobiological products (vaccines, allergen- and blood products), both locally manufactured and imported.

Since 2001 NCE has been involved in the assessment of Marketing Authorisation (MA) application and in the control authority batch release of human immunological products, on request and on order of the competent authority.

The practical implementation of the above mentioned tasks in NCE are performed by the unit of Quality Control for Immunobiologicals.

Through the activities of its control laboratories NCE is a member of the WHO National Control Laboratories (NCLs). Since 2004 NCE has been the member of the network of Official Medicines Control Laboratories (OMCL) of the European Directorate for the Quality of Medicines and HealthCare (EDQM).

The Quality Control for Immunobiologicals has been accredited by the Hungarian Accreditation Board.

The handling of AEFI (Adverse Events Following Immunisation) cases, involvement in the investigation and reporting the results are the duties of the Quality Control for Immunobiologicals. In addition, the unit is actively involved in the maintenance of a WHO accredited home page which contains information for health professionals and also for the large public on the safety of vaccines, vaccination and allergen products. The members of the unit are involved in several international and national researches, regulatory processes and/or training projects, e.g. FLUSECURE, VACSATC, FastVac, VAESCO and EDQM GEON.


For more detailed introduction of the unit of Quality Control for Immunobiologicals please click here



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