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Guidance on UK Procedures for product renewal applications (Article 43 of Regulation 1107/2009)

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.

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:

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:

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.

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, 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

Updated 2017-01-17