EMA (EMEA) Compliant Testing

Materials Tested:
Animal Origin Products
Virus Seeds
Cell Lines
Vaccines

EMA assays evaluate the test article for extraneous viruses, satisfying the following regulations:

• EMA/CVMP/743/00-Rev.2 (2005) 4.3.3.1, 4.3.3.2
• EMA/CPMP/BWP/1793/02 (2003) 5.3.1, 5.3.2, 5.3.3
• European Pharmacopoeia 5.2.5 (01/2005:50205)
• General Requirements for Inactivated (7Blm2a) and Live (7Blm1a) Vaccines for Veterinary use
• USDA-APHIS 9/CFR § 113.53c (which includes § 113.46 and § 113.47)

Full EMA compliant testing for Bovine materials includes the following (these tests are also available individually):

• GIEMSA staining and FA as required (22 days)
• BVD comparative tritration (29 days)
• BVD quantitation (8 days)
• Beta serum neutralization (SN) (8 days)
• Virus reduction (8 days)
• Alpha serum neutralization (optional, 8 days)

EMA Compliant Testing is available for Bovine origin materials. ABR also offers EMA method testing for other species of origin. Please inquire.

Extended assay descriptions can be read here or downloaded here.

Minimum Testing Time From Start of Test: 29 days

About EMA

Click here to learn more about the EMA.

Please call us for more information, or read some of our Frequently Asked Questions.

Don’t see what you’re looking for? We also offer custom testing!