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EMEA conforming products

The European Agency for the Evaluation of Medicinal Products (EMEA) has issued two directives that apply to the use of bovine serum in the production of medicinal products.

EMEA/CVMP/743/00-FINAL from the Committee for Veterinary Medicinal Products (CVMP) Guideline on requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products

 

EMEA/CPMP/BWP/1793/02 from the Committee for Proprietary Medicinal Products (CPMP) Note for guidance on the use of bovine serum in the manufacture of human biological medicinal products

 

To support medicinal manufacturers who utilize bovine serum in their processes, a line of EMEA conforming products that meet the scope of both directives has been created. We recognize the need for high quality, traceable bovine serum, which is tested (and inactivated as required) to meet both directives.

 

Where applicable, our EMEA Conforming products are tested per European Pharmacopoeia protocols and irradiated at the required minimum dose. These EMEA Conforming products provide medicinal manufacturers with the assurance of receiving high quality, consistent product that conforms to the requirements. Complete versions of both directives can be found atwww.emea.eu.int.