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For example, if France is selected as the RMS (National Authorisation = €40,000) and Spain and Poland are acting as the CMSs for Mutual Recognition (Spain as CMS = €1,172.00; Poland as CMS = €1,451.86), the total cost of the product authorisation applications would be €42,623.86. However if Spain acted as the RMS (Nation Authorisation = €2,461.22) and Poland and France (France as CMS = €15,000) were the CMSs then the total cost would be €18,913.081
. Mutual Recognition
may be best suited to businesses who market in up to 5 or 6 Member States, whereas a business with a larger marketing area may benefit from Union Authorisation.
Union Authorisation
Union Authorisation allows authorisation holders to place their biocidal product(s) on the market throughout the EU and EEA following submission of one authorisation application to the eCA. Currently, all biocidal products with the exception of those marketed for use in product types 14, 15, 17, 20 and 21 and products containing active substances which fall under the BPR Exclusion Criteria are eligible to be granted Union Authorisation. Union Authorisation submission fees are set by the European Commission and have not changed since the BPR was published in 2012 (Table 3). However, ECHA fees are subject to review and change e.g. due to inflation. The standard submission fee is €80,000.00 plus an additional €10,000.00 annual fee. Member States will charge additional fees if they are the eCA, for example, the Netherlands charge €4,216.00 as a basic application submission fee, plus evaluation fees.
Cost Comparison Conclusions The three authorisation routes described above have different timescales and specific requirements and there is considerable variation between the evaluation fees payable to Member States for National Authorisation and Mutual Recognition. The choice of eCA can have a significant impact on the total fees payable, including renewal fees. Each Member State has specific criteria for accepting the role as the eCA and it can be time consuming to determine all Member States particular requirements and fees involved. Furthermore, additional fees may be required for administration and submission purposes such as changes required to the submitted information or submission of product authorisation application for use in more than one product type.
This cost comparison table includes the most up to date information on all available Member State fees in order to understand which route is the most economical and appropriate for a prospective product authorisation applicant.
DISCLAIMER
The above information was correct at the time of publication; the cost comparison tool is intended for use in conjunction with the latest ECHA Fee Regulation, eCA fees, and any discussions with the appropriate eCA.
The hyperlinks for the following references can be used if viewed via Lube Digital which can be found here
www.lube-media.com/archive.
References/Supporting documents BPR
Fees Regulation
Practical Guidance Documents Biocidal Product Authorisation Member State Competent Authorities ECHA Supporting Documents
Competent Authority Meeting 58. Report on Fees. Document 7.2
LINKS
www.thereachcentre.com www.chemtracglobal.com
1 Annual fees should be included where available.
Table 3. Union Authorisation fees for all Member States and EEA Member States. 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.
Petrico launches new website
Petrico, the expert supplier of speciality products into the petroleum and chemical industries with extensive experience of the lubricants and additives markets, has launched its brand new website to the public.
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The new site features a range of cutting- edge functionality including a full-width design, in keeping with current trends in web design, and is also designed to accommodate visitors on smartphones and tablets seamlessly. The ‘News’ section
LUBE MAGAZINE NO.136 DECEMBER 2016
will also keep visitors up to date the latest company and industry developments.
LINK
www.petrico.com
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