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Autogenous Vaccine Regulations

NationWide Laboratories has been fully licensed by the Veterinary Medicines Directorate (VMD) to produce autogenous vaccines since 1986 and has full Good Manufacturing Practice (GMP) accreditation through the VMD.  All production is TSE risk compliant.

The VMD produce the Veterinary Medicines Regulations (VMR), which set out the UK controls on veterinary medicines, including their manufacture, advertising, marketing, supply and administration.  Guidance notes on the VMR (VMGN 1-20) are available but are intended as a supplement to European guidance (Directive 2001/82/EC as amended by Directive 2004/28/E, EEC Directive 91/412/EEC, EudraLex: EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use).  Prescribing an autogenous vaccine should be made after evaluating The Cascade.

VMD requirement for autogenous vaccine production:

  • If no commercial vaccine for pathogen exists or
  • Serotypes involved in the disease outbreak are not included in the commercial vaccines or
  • The disease is occurring in an age group or species for which the commercial vaccine is not licensed or may have adverse effects.

Autogenous vaccines are produced under the marketing authorisation, Autogenous Vaccine Authorisation – Standard (AVA-S).  The AVA-S is valid for a manufacturing premises, using standard production methods to produce an inactivated, consistent and safe vaccine.  The AVA-S is valid continuously, subject to satisfactory inspection by the VMD.

NationWide Laboratories also holds an Autogenous Vaccine Authorisation to produce individual vaccines (AVA-I), specifically for papillomaviruses.  Contact the Leeds laboratory for more information (Tel.  0113 250 7556).

Safety Dose

No toxicity testing is carried out at the laboratory.  Therefore, there is a requirement for in vivo testing in two healthy animals in the target group.  The safety test is performed with a double dose of vaccine.  The animals should be monitored and any adverse reactions reported to NWL – Leeds immediately.

Good Manufacturing Process

GMP is defined as the part of Quality Assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use. ( https://www.gov.uk/guidance/manufacturing-authorisations-for-veterinary-medicines )

The EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines – contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC and as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

TSE-risk compliant

As a rule, and unless properly justified, all animal by-products used as starting materials in the manufacture of medicinal products should be ‘Category 3 (i.e. safe) materials or equivalent’, as defined in Regulation (EC) No 1774/2002 (European Commission directive 2001/C 73/01).

All vaccines manufactured by NWL – Leeds are TSE-risk compliant.