Renewal of pesticide product authorisation
The process for renewal of plant protection product (PPP) authorisations is described by Article 43 of Regulation 1107/2009 as it applies in Great Britain/Northern Ireland and is further explained in the Guidance document SANCO 2010/13170. This specific guidance explains what is required by HSE.
In summary:
- A product renewal application is required for every product containing a renewed active (either alone or in mixture) within 3 months of the renewal of that active substance
- If the renewal dates are different in Great Britain (GB) and Northern Ireland (NI) and you wish to maintain authorisation in both territories, separate GB and NI applications will be required at each relevant deadline
- If active substance renewal conditions are different in GB and NI, separate article 43 applications will be required. In this case you may, under the provisions of the NI Protocol, still choose to include NI in the Central zone/ interzonal renewal process
- Products not supported at the 3-month deadline will expire 1 year after renewal of the approval of the active substance. A subsequent 18-month grace period will apply for existing stocks. This will normally comprise an additional 6 months sale plus 12 months storage and use
- Voluntary changes in the formulation or GAP of a product cannot be considered under an Article 43 renewal application. If you wish to make a change to the formulation or authorised uses then this must be submitted under a separate Article 33 application. If a change in GAP is unavoidable (for example, it is driven / triggered by a change in end points and/ or guidance documents) then this should be highlighted. A justification for each use/change is required.
Timing of a renewal application
The Regulation requires an Article 43 submission for each authorised product within 3 months of the active substance renewal date. If a product contains more than one active, an Article 43 application is required within 3 months of the renewal of each active substance in the product. Whilst the application must always be submitted within 3 months of active substance renewal, in certain circumstances the draft Registration Report may be delayed due to either:
- Category 4 data as described in paragraph 3.8 of the renewal guidance document
- The product contains 2 actives which expire within 12 months of each other (as described in para 3.9 of the renewal guidance document)
NOTE: HSE cannot issue any authorisations for products considered to the old endpoints after the renewal Date of Application. Please bear this in mind if you are submitting a non-renewal application close to the expected renewal of an active substance.
How active substance renewal impacts on a product authorisation.
Submission requirements
Authorisation holders should make all renewal applications for their products containing a particular active substance at the same time and at the latest by the application deadline. Applications should include the following:
1. Covering letter and application overview
The covering letter or application overview should summarise what has been supplied and briefly detail how the product portfolio is being supported through the renewal process (this should include highlighting risk envelopes and data access agreements).
It should highlight whether there is any difference in the active substance status in GB and NI. If the renewal dates and requirements are the same in both territories, we would aim to issue a single authorisation valid in both territories. Where divergence is necessary and the product is being supported in both territories, we may require a second application. Please note that applications for NI only may still follow the zonal and mutual recognition processes.
The application overview should summarise each area of the risk assessment identifying what has changed and therefore which areas of the risk assessment have been updated.
2. Renewal application form
A completed renewal application form (CRD-R) for each product is required. Please note that the form allows for the inclusion of existing identical (back-to-back) products and Extensions of Authorisations for Minor Use (EAMUs) that are supported within the renewal draft Registration Report (dRR).
The application form includes two declarations under Part C the first relating to compliance of the use(s) with conditions in the Approvals Register for the active substance and the second relating to compliance of the source of the active substance. Both declarations must be confirmed for each product. A description of how to determine compliance with the second declaration (relating to technical material) can be found in our guidance on technical specifications. Products which cannot satisfy both declarations are ineligible for the renewal process or Art 43.6 Cat 4 extension.
3. Draft label
A draft label for each product is required. There should be no change to the wording of this document from that which was previously authorised (other than to reflect GAP changes necessary to support a satisfactory risk assessment).
4. Demonstration of access to the active substance data
Applicants must demonstrate access to, or match, the relevant active substance data relied upon during the renewal of the active substance.
Applicants may demonstrate access by providing:
- Evidence of ownership
- Letter (s) of access from the data owner (or for vertebrate studies, evidence that negotiations are ongoing)
- Matching studies (except vertebrate studies). These can be equivalent information/ studies including published studies
- Evidence that the protected studies are not relevant to the product/ use
- Applicants may identify active substance data which fall into category 4 (insufficient time to generate) as defined in the product renewal guidance document. In these circumstances a justification must be provided which addresses:
- i: Why the study could not have been anticipated in sufficient time to include a matching study or evidence of data access with the product renewal application
A declaration that the study is underway - ii:When the matching study will be available
- i: Why the study could not have been anticipated in sufficient time to include a matching study or evidence of data access with the product renewal application
Unless the submission is reliant solely on the active substance data relied upon for approval or on a letter of access to such data, a table in the correct format must be submitted (see links below).
5. A copy of the authorisation
6. A list of new studies supplied
Please use the template for the study list in Article 43 applications. This must include evidence/ justification that the new data provided (or to be submitted if Cat 4 applies) are necessary as a result of data requirements, endpoints or guidance documents that were not in force when the authorisation of the PPP was granted.
7. A draft Registration Report (dRR) which presents new data and risk assessments required as a result of amendments in data requirements and criteria
Renewal requires the product risk assessment to be updated to reflect new data requirements and new criteria (for example, endpoints, guidance).
New data requirements will apply to the majority of renewal applications submitted from 2020 onwards, therefore the new dRR format applies. A very few new dRRs may be in response to an AIR 2 active substance renewal. In these circumstances the old format dRR remains acceptable, although is generally not preferred.
You can use theses dRR templates
HSE will continue to accept dRRs prepared for a zonal submission in the central zone (or interzonal submission, if relevant) (that is a core dossier plus national addenda).
What the dRR should include
A complete dRR containing a full product risk assessment is required. However, the existing risk assessment only needs updating where the data requirements or criteria have changed.
A summary should be provided at the beginning of each section of the dRR (this may be similar/ the same as the summary for the relevant risk assessment area in the application overview and detail what has changed and what needs to be reconsidered). Where sections of the risk assessment have been updated this should be clearly identified either by highlighting the updated sections or by greying out the sections that have not been updated. It should be explained when and by whom each section of the assessment was undertaken (Regulatory authority or applicant). You can use theses dRR templates.
HSE encourages authorisation holders to support the renewal of existing extensions of authorisation of minor use (EAMUs) within their dRR. If doing so they should ideally be identified in B0 as EAMUs. They should also be highlighted on the relevant section of the application form. In these circumstances it is assumed that the authorisation holder (or applicant) accepts that EAMU fees will be applied (in addition to the product assessment fee). Please note that we advise growers/ grower groups to liaise with authorisation holders regarding their renewal plans. If the authorisation holder does not support the use at renewal, growers/ grower groups can apply for renewal later (although they will be required to demonstrate appropriate data access). Separate guidance on renewal of EAMUs by growers is available.
8. Comparative assessment
This is required if the product contains a candidate for substitution.
9. Letter(s) of access (where applicable)
Note that if administrative back-to-back products are highlighted in the application form and these have different authorisation holders then any letters of access must cover all requested companies.
Fees for renewal
HSE will charge renewal applications according to the current modular fee system. Applications which request a delayed submission of the supporting dRR (mixed actives / Cat 4 data) will initially be charged fees to cover the work required at this stage of the assessment (including the compliance checks). The full assessment fee will be determined and invoiced when the complete dRR is submitted.
Extension of existing authorisations during renewal process
Where, for reasons beyond the control of the holder of the authorisation, it is not possible to conclude on the Article 43 product renewal application within 12 months of the date of application of the renewal of the active substance, HSE will extend the existing product authorisations to allow time for the renewal assessment to be completed. This extension will apply where a delayed submission of the dRR has been agreed on the basis of Category 4 data, or due to mixed active substances expiring within 12 months of one another. It will also apply where, for reasons of lack of resource availability, we are unable to complete the assessment within the timelines.
To avoid having to repeatedly extend the authorisation due to changing expected completion dates, HSE will extend the affected authorisations once and replace the existing expiry date with the following wording:
'This authorisation remains extant until a regulatory decision is taken under the ongoing application for renewal of this product under Article 43 of Regulation (EC)1107/2009 (and upon the condition that a complete dossier is supplied by the submission date agreed by HSE) unless an earlier decision is taken. Upon expiry of this authorisation there will an additional 6-month grace period for the sale and distribution of existing stocks and a further 12-month grace period for the disposal, storage and use of existing stocks. When this decision is taken, a withdrawal notice specifying the grace period will be published.'
If no submission is made by the agreed date, the authorisation will be immediately withdrawn (subject to the Article 46 grace period).