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EMAV / Maarten de Gussem/ 14 th of September 2021
EMAV / Maarten de Gussem/ 14th of September 2021
The start of EMAV was driven by the legislative process (EU-regulation 2019/6) to create a legal framework and hereby to harmonize the rules for production and use of autogenous vaccines and sera within the EU.
Founded in November 2018 in Hannover/GE.
Listed as HMA (Heads of Medicines Agencies) vet stakeholder (Dec. 2019).
} Representation of the common interests of Europeanproducers of autogenous vaccines.
} Promotion of the European harmonization process combining the interests of manufacturers.
} Partner with veterinarians and other stakeholders to strengthen the health of animals and humans by the prophylactic use of autogenous vaccines in animals.
} Help developing the future GMP standards in a way to combine securing the safety and ensuring the availability of the products, even for very small number of animals.
} Public and private◦ Subsidiary of licensed vaccine groups◦ Independent AV producers
} Focus on different species } Wide variation of production facility lay-out} Wide variation of procedures used for production,
inactivation and quality} Different levels of interaction with veterinarians} Different legislation to be followed} Geographically spread all over EU
} TWO WORKING GROUPS WORKING INTERNALLY:SCIENTIFIC WORKING GROUP (SWG) :
Expert team experienced in development, manufacturing, quality and regulation of autogenous vaccines, supportive in the evaluation of all
scientific issue relevant for EMAV PRACTICE ADVISORY GROUP (PAG):
For the definition of basic requirements for the target-oriented use of autogenous vaccines by vet professionals in different species in an European
harmonized market, focused on the appropriate usage of autogenous vaccines under field conditions.
} GENERAL ASSEMBLY Reflection on preparations of SWG and PAG, discussion and approval by the members represented in General Assembly. This guarantees positions that are broadly supported by the manufacturers, facilitating other stakeholders to interact with the manufacturers in an efficient way.
Regulation (EU) 2019/6 and its implementing acts for the production of autogenous vaccines
} Will harmonize the manufacturing of Autogenous Vaccines in the
EU for the first time.
} Will create a new EU-GMP standard for manufacturing of
autogenous vaccines.
} Assures that future autogenous manufacturers produce and control
under better defined and controlled conditions.
Regulation (EU) 2019/6 will harmonize
} The primacy of licensed products remains clearly defined
} Other EU member states must accept certificates of GMP and allow
import of autogenous vaccines.
} AV must be manufactured from pathogens obtained from an animal
or animals in an epidemiological unit.
} AV may be used for animals in the same epidemiological unit or
animals having a confirmed epidemiological link.
Autogenous vaccines play a key role in the strategic global health concept for:
} Implementation of prophylactic measures for reduction of use of
antibiotics in production and companion animals.
} Protection of animal welfare & endangered species.
} Consumer protection due to harmonised quality standards.
} Global nutrition of humankind/ the economics of animal husbandry.
} Protection of the environment.
} On this moment, the wide variation in production processes hampersinvestment◦ Different production processes go with different cost
◦ Interferes with cross-border activities
} Once harmonisation is achieved, a boost of investments expected toadvance solutions for the animal health industry
} All EMAV members have different infrastructure and procedures, and experiences!
} This has been THE challenge to understand within EMAV, but alsobecame an opportunity to propose what a AV GMP could look like!
} CMDv paper used as the starting point, worked out further in several meetings in General Assembly◦ 2018 Hannover◦ 2019 Hannover◦ 2019 Amsterdam◦ 2019 Budapest◦ 2020 Brussels◦ 2021 Online
} During these meetings, we◦ Agreed on the process to be followed, including the interim preparation by technical
specialists from different producers with discussion and approval in GA◦ Decided on the content of the paper. Main discussion on production and conditions of
use, should it be in one document or separated?◦ First attempt was to have one document, covering both topics◦ The resulting document was not deemed to be the best possible approach by the
general assembly: many discussions arose on interference of the clauses on conditions of use with the production clauses
EMAV / Maarten De Gussem / 28th of June 2021
} On the other hand, for the GMP production, a solid consensus was reached
although the initial starting points from different producers were very
different
} The position paper was approved unanimously by all members of EMAV, indicating
a broad support within the current autogenous vaccine producers from different
countries, with different focus on animal species, in line with CMDv position paper
and written by technical experts of manufacturer’s
} The position paper will be presented by several speaker’s of EMAV members
EMAV / Maarten De Gussem / 28th of June 2021
} An expert and stakeholder discussion on AV manufacturing standards
◦ Explain the complexity from a manufacturing point of view to stakeholders
◦ Understand the needs from different stakeholders (animal owners, veterinarians,
competent authorities) on the AV manufacturing standards
◦ Get feedback on the GMP-EU AV EMAV proposal from different stakeholders
◦ Understand what standards can be agreed upon with stakeholder consensus but
also define critical points
