Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE

More documents

Recommendations

Info

Article in 528/2012 Article Text 34 33(5) – Within 90 days of receipt of the documents referred to in paragraph 4 […] the Member States concerned shall agree on the summary of biocidal product characteristics, and hall record their agreement in the Register for Biocidal Products […] 33(6) – Within 30 days of reaching agreement, the reference Member State and each of the Member States concerned shall authorise the biocidal product in conformity with the agreed summary of biocidal product characteristics. 39 39(1) - […] official or scientific bodies involved in pest control activities or the protection of public health may apply, under the mutual recognition procedure provided for in Article 33 […] The application shall be accompanied by the fees payable under Article 80. 39(2) – Where the competent authority of the Member State concerned considers that the biocidal product fulfils the conditions referred to in Article 19 and the conditions under this Article are met, the competent authority shall authorise making available on the market of the biocidal product […] Service provided/ estimated cost range Processing and determining an application for mutual recognition in parallel as concerned Member States. £1,420 (min) Sift, Co-ordination and 1 Specialist Case £3,920 (max) as above but with 6 Specialist Cases Processing and determining an application for mutual recognition by an official or scientific body. £1,420 (min) Sift, Co-ordination and 1 Specialist Case £3,920 (max) as above but with 6 Specialist Cases Daily rate/ estimated timescale range £393 3.6 days 10 days £393 3.6 days 10 days Comments Covers HSE’s work in mutually recognising a biocidal product in parallel when it acts as concerned Member State (i.e. not the Member State to whom the main application is made). 10
Article in 528/2012 Article Text 43(3) Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if the relevant information referred to in Article 20 has been submitted. Service provided/ estimated cost range Validating an application for Union Authorisation of a biocidal product. £220 Sift Daily rate/ estimated timescale range £393 0.6 days Comments Covers HSE’s work in validating an application for Union Authorisation – initial validation/completeness check (no substantive assessment). 44(1) The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Article 19 […] and send an assessment report and the conclusions of its evaluation to the Agency. Evaluating an application for Union Authorisation of a biocidal product. £150 (min) admin only i.e. Marketing Authorisations £10,900 (max) Technical Sift, Coordination, 6 Specialist Data and an EU Surcharge £393 0.4 days 28 days 11
Page 1 and 2: Consultation on Fe
Page 3 and 4: ensures compliance with the require
Page 5 and 6: Annex 1 - Proposed biocides fees st
Page 7 and 8: Article in 528/2012 Article Text 14
Page 9: Article in 528/2012 Article Text 31
Page 13 and 14: Article in 528/2012 Article Text 50
Page 15 and 16: Annex 2 - draft statutory instrumen
Page 17 and 18: (6) Where a person becomes liable t

Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?