All diagnostic kits for diseases, including zoonoses, caused by pathogens (viruses, bacteria, prions and parasites) present in terrestrial and aquatic animals can be certified by the OIE and included in the Register in the framework of this procedure.
The applicant must pay an assessment fee of 4 500 € to initiate an evaluation of the data provided by a panel of experts. This is the case for the first assessment of the application and this might be the case when there is a change to a diagnostic kit currently included in the register or for the renewal of the registration (see Section 2 of the Standard Operating Procedure).
Once a diagnostic kit is included in the OIE register, the manufacturer or his authorised representative must pay an annual loyalty fee that consists in 0.1% of pre-tax annual cumulated turnover of the previous year gained from sale of the diagnostic kit registered by the OIE.
For the first year only, the annual loyalty fee is calculated for 7 months. This is because diagnostic kits are included in the register during the OIE General Session in May (after a vote by the World Assembly of Delegates).
Every year, between 1 and 15 January, the manufacturer or his authorised representative must pay the annual loyalty fee and send a profit justification for the diagnostic kit.
If the fee is not received on time, the OIE will remove the diagnostic kit from the OIE web site and the manufacturer or his authorised representative must no longer state that his diagnostic kit is validated and certified by the OIE. Any violation of this rule is liable to legal action by the OIE against the manufacturer.
An administrative fee of 650 € must be paid by any applicant wishing to appeal a negative opinion of the relevant Specialist Commission (Biological Standards Commission or Aquatic Animal Health Standards Commission) within 10 days of receipt of the opinion.
The applicant should pay by bank transfer to OIE Account:
Crédit Industriel et Commercial
Bank Code 30066 – Branch Code 10141
Account Number: 00010308807– Key 38
Code BIC/SWIFT: CMCIFRPP
N° IBAN: FR76 3006 6101 4100 0103 0880 7 38
While effecting the bank transfer, kindly include the name of your country followed by the Code “007”.