A biological medicinal product is a product derived from living organisms ranging from normal or genetically modified microorganisms to fluids & tissues derived from various animal & human sources.
The Marketing Authorization department in NORCB main responsibility is the protection and promotion of public health, by carrying out analysis in the concerned labs and scientific evaluations of Biological products for human use.
The outcome of NORCB’s evaluation is used by the Egyptian Ministry of Health to decide whether a Biological product can be authorized for marketing in Egypt.
NORCB charges pharmaceutical companies fees for the services it provides, including a list of the fees charged for each type of procedure. Fees are adjusted for inflation. (Attachment price list).
- For Registration according to Ministerial decree 297/2009: 120 working days
- For registration according to Fast track procedure: 90 working days
- For registration according to 820 decrees:
One month for EMA & FDA approved products submitted through Ministerial decree 820/2016.
Two months for EMA or FDA approved products submitted through Ministerial decree 820/2016.
VVMs are only used in case of temperature elevation (more than 8 ºC). In case of temperature decrease, other conditions, such as the minimum temperature reached, the period of temperature deviation, product packing inside the cold chain and the volume per unit, are taken into consideration to assess the product’s permissibility for use.
Only medical biological products that are previously registered by NORCB are tested.
Medical equipment such as IV sets and syringes are not tested at NORCB.