The fee for National Authorisation can range from €297.08 in Romania to €100,000.00 in Cyprus (Figure 2). This fee includes product evaluation and annual fee, if any, however there may be additional fees such as administration costs (Czech Republic), notification fees (Finland) and completeness check fees (France). The variation in fees (Table 1) can be attributable to a number of factors ranging from expertise and resources available to application assessment and administration costs.
In addition to the fees for National Authorisation Table 1 also shows the total cost for a National Authorisation in the first 10 years of marketing a biocidal product. Year 1 is calculated by totalling the evaluation fee and the annual fee (if any), year 2–9 is the total annual fee for 8 years and year 10 is calculated using the National Authorisation renewal fee and the annual fee.
Table 1. National Authorisation fees for 28 Member States and EEA Member States and the total cost of National Authorisation in year 1, years 2–9 and authorisation renewal (based on a maximum of 10 years of marketing the biocidal product). This includes the individual evaluation fee, annual fee (if any) and authorisation renewal fee. The figures below reflect the standard amount charged and do not include fees such as additional product-types or changes to be made to the authorised product. The figures below were correct at time of publishing. Conversion rates on 29/09/2016 were used to calculate to EURO.
product authorisation must be granted in one Member State first, the Reference Member State (RMS), then a request must be made to the other Member State(s), the Concerned Member State(s) (CMS), to recognise the authorisation. Alternatively, Mutual Recognition in parallel allows one to apply for product authorisation in one Member State (the RMS) and simultaneously request a recognition of product authorisation in other Member States as soon as it is granted by the RMS. Mutual Recognition fees can vary among Member States. The CMS Mutual Recognition fees are added to the original National Authorisation evaluation fee of the RMS. There is no difference in charges for Mutual Recognition in parallel or in sequence. CMS costs for Mutual Recognition can range from €81.55 in Romania to €15 500.00 in Germany (Table 2). In addition to this, a submission fee of €700 per biocidal product per Member State where Mutual Recognition is sought must be paid to ECHA.
Table 2. National Authorisation and Mutual Recognition fees for evaluation and renewal in 28 Member States and EEA Member States. This includes the individual evaluation fee, annual fee (if any) and authorisation renewal fee. CMS = Concerned Member State. The figures below reflect the standard amount charged and do not include fees such as additional product-types or potential changes to be made to the authorised product. The figures below were correct at time of publishing. Conversion rates on 28/09/2016 were used to calculate to EURO.
Mutual Recognition
Mutual Recognition is available to National Authorisation holders wishing to extend their marketing reach to other Member States. There are two types of Mutual Recognition; in sequence and in parallel. For Mutual Recognition in sequence
If a company wishes to market their biocidal product in at least two Member States then the cost comparison table can be used to find the most cost-effective solution for biocide product authorisation (Table 1 and 2).
Continued on page 44 LUBE MAGAZINE NO.136 DECEMBER 2016 43
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