Textual Amendments
F1Sch. 1 substituted (6.4.2016) by The Plant Protection Products (Fees and Charges) (Amendment) Regulations 2016 (S.I. 2016/254), regs. 1, 2(2)
2. The fees for evaluation for approval, or renewal of approval, under Regulation 1107/2009 of an active substance, safener or synergist, are in accordance with the following table.
| Item | Application | Fee(£) | |||||
|---|---|---|---|---|---|---|---|
| Where an active substance, safener or synergist is neither a biocontrol agent nor a pheromone | |||||||
| 1 | Preliminary evaluation(1) of the admissibility of an application | 5,200 | |||||
| 2 | Processing an application for provisional authorisation (2) | 36,400 | |||||
| 3 | Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is the rapporteur or co-rapporteur Member State in relation to an application for approval | 36,400 | |||||
| 4 | Evaluation of a full data package(3) | 114,400 | |||||
| 5 | Evaluation of a partial data package(4): | ||||||
| Band 1 | 7,800 | ||||||
| Band 2 | 15,600 | ||||||
| Band 3 | 31,200 | ||||||
| Band 4 | 52,000 | ||||||
| Band 5 | 72,800 | ||||||
| Band 6 | 93,600 | ||||||
| Band 7 | 114,400 | ||||||
| Where an active substance is a biocontrol agent | |||||||
| 6 | Evaluation of a full data package (3) | 23,400 | |||||
| 7 | Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is the rapporteur or co-rapporteur Member State in relation to an application for approval | 7,800 | |||||
| 8 | Evaluation of a partial data package(4): | ||||||
| Band 1 | 5,720 | ||||||
| Band 2 | 11,700 | ||||||
| Band 3 | 17,680 | ||||||
| Band 4 | 23,400 | ||||||
| Where an active substance is a pheromone | |||||||
| 9 | Evaluation of a full data package(3) | 13,520 | |||||
| 10 | Helping the European Food Safety Authority to evaluate the draft assessment report where the United Kingdom is the rapporteur or co-rapporteur Member State in relation to an application for an approval | 7,800 | |||||
| 11 | Evaluation of a partial data package:(4) | ||||||
| Band 1 | 3,380 | ||||||
| Band 2 | 6,760 | ||||||
| Band 3 | 10,140 | ||||||
| Band 4 | 13,520 | ||||||
| For all evaluations | |||||||
| 12 | Meeting before the submission of an application in support of a new active substance, safener, synergist, biocontrol agent or pheromone | 5,200 | |||||
Notes
(1) The initial evaluation carried out in order to notify the applicant whether his or her application can proceed further.
(2) Application in accordance with Article 30 of Regulation 1107/2009 for a provisional authorisation in the United Kingdom (not exceeding 3 years) for a plant protection product containing a new active substance for which a decision on approval has been delayed by more than 30 months from the date of admissibility of the original application.
(3) A full data package comprises the complete dossier (the information referred to in paragraphs 1 and 2 of Article 8 of Regulation 1107/2009) to support one or more representative use of one product. Where a data package also contains a large number of extra study reports submitted to refine risk assessments, to characterise metabolites or to support additional uses of the product, these studies will be treated as an additional partial data package. See also note (4).
(4) The size of a partial data package is banded as a proportion of a full data package. The proportion is estimated on the basis of the amount of time required to evaluate the data and to conduct the necessary risk assessments. Applicants will be notified of the appropriate Band prior to an evaluation taking place. Partial data packages include one or more of the following—
(a)additional data over and above a ‘standard’ core dossier for example situations where there are significantly more metabolites, or very large novel studies to be evaluated;
(b)additional study submissions during evaluation required to clarify the initial dossier;
(c)resubmissions where, for example, the previous application for approval or inclusion in Annex 1 to Directive 91/414/EEC or for approval or renewal of approval under Regulation 1107/2009 has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission;
(d)data to support the extension of the approval of an active substance, safener or synergist under Regulation 1107/2009 once the initial approval period has expired or to change the conditions of approval during the approval period;
(e)data to support the evaluation of an active substance under Regulation 1107/2009 once the initial period of inclusion in Annex 1 of Directive 91/414/EEC has expired. The full dossier is not required just additional data to demonstrate compliance with any new guidance, regulations or scientific advances;
(f)large data packages in one or more areas of the risk assessment that have been submitted in support of product related applications (e.g. re-registration and new product applications under Regulation 1107/2009) that significantly exceed the size for which the standard fees specified in the product-related application fees table (paragraph 1, items 9a-g above) are payable.
(g)Additional studies submitted to support an adverse data review.
A joint evaluation where the United Kingdom and one or more other Member States share the evaluation of a dossier and evaluation of scientific peer reviewed open literature on the active substance and its relevant metabolites will be treated as partial data packages.]