Guidance on UK Procedures for product renewal applications (Article 43 of Regulation 1107/2009)
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
The process for renewal of product authorisations is described by Article 43 of Regulation EC No 1107/2009 (1107) and is further explained in the EU Guidance document SANCO 2010/13170. This UK specific guidance explains what is required by HSE and how HSE will charge for this work.
- A product renewal application for every product containing a renewed active (either alone or in mixture) must be submitted within 3 months of the renewal of that active substance.
- The zonal Rapporteur Member State (zRMS) for the product renewal must be agreed in advance. The application must be made to all MSs in which the product is being supported (the zRMS and the ‘concerned Member States’ (cMS)).
- Products not supported at the 3 month deadline will expire 1 year after the expiry of the previous approval of the active substance. A subsequent 18 month grace period, comprising of an additional 6 months sale plus 12 months storage and use, will normally apply.
- 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 (e.g. 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.
Renewal guidance continues to be developed and will be updated and added to the HSE website as we gain experience.
Timing of a Renewal Application
The Regulation requires a submission, within 3 months of the related active renewal deadline, for each product authorised in the UK. Submissions are required for each relevant active substance deadline if a product contains more than one active. This includes those products where the UK is zRMS, cMS or where the submission and assessment of the draft Registration Report will be delayed due to either:
- Category 4 data as described in paragraph 3.8 of the EU guidance document.
- The product contains 2 actives which expire within 12 months of each other (as described in para 3.9 of the EU Guidance document).
NOTE: HSE cannot issue any authorisations for products considered to the old endpoints after the renewal Date of Application (except where we are a cMS). Please bear this in mind if you are submitting a non-renewal application close to the expected renewal of an active substance.
UK Submission Requirements:
Authorisation holders should make all renewal applications for their products containing a particular active substance at the same time. Applications should include the following:
1. Covering letter & 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 (highlighting risk envelopes, data access agreements etc.).
2. Renewal application form
A completed renewal application form (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 (relating to compliance with the renewal regulation). 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 Technical Specification at Renewal guidance. 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.
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.
For AIR2 active substances, the active substance RMS will produce a list of new data relied upon and this should be available from the Commission website and a copy uploaded to the public area of CIRCABC. If the list is not yet available please contact the RMS directly to request this. In future such a list will be made available with the EFSA conclusion.
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)
- 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 SANCO 2010/13170. In these circumstances a justification must be provided which addresses:
- Why the study could not have been anticipated prior to the publication of the renewal EFSA conclusion
- Why there was insufficient time from publication of the EFSA conclusion to submission of the product renewal dossier to generate an equivalent study, or negotiate access to the original study
- A declaration that the study is underway
- When the matching study will be available
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 format provided must be submitted.
5. A copy of the UK authorisation
6. A list of new studies supplied
Please use the table: 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 (AIR 3 and later), and criteria.
Advice on how to approach the dRR for renewal:
Which version of dRR ?
Renewal requires the product risk assessment to be updated to reflect new data requirements and new criteria (endpoints, guidance etc).
For AIR2 renewal submissions there are no new data requirements to consider and as a consequence applicants should use the ‘2009’ version of the registration report (SANCO 6895/2009).
For AIR 3 onwards, new data requirements and the new dRR format apply.
See European Commission website page under "Procedural guidance: Dossier and draft assessment report" for guidance and format.
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.
With each product submission an application overview looking at each area of the risk assessment should be provided. This should summarise what has changed and what areas of the risk assessment need to be reconsidered.
A similar summary should be repeated at the beginning of each section of the dRR. 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).
In the case of products containing 2 or more actives where original expiry dates are within 12 months of each other, or where Cat 4 data is justified, the dRR submission can be delayed until all data are available.
8. Comparative assessment
(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. The full assessment fee will be determined and invoiced when the complete dRR is submitted.
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, the zRMS is unable to complete their 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) No 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."
The text in bold would only be included where a submission deadline had been set for the submission of the complete renewal draft Registration Report (dRR) for the renewal application. If no submission is made by the agreed date, the authorisation will be immediately withdrawn (subject to the Article 46 grace period).
Further Information Links
Renewal application form - CRD-R
Table format for Matching Protected Annex II Data For AS
Table format for the study list in Article 43 applications
Technical Specification at Renewal guidance
Timelines for Renewal diagram