December 4, 2022

Agreed Upon Procedures Report Template

The action for face-lifting of bulb aegis artefact (PPP) authorisations is declared by Commodity 43 of Regulation 1107/2009 as it applies in Great Britain/Northern Ireland and is added explained in the Advice certificate SANCO 2010/13170. This specific advice explains what is adapted by HSE.

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In summary:

The Regulation requires an Commodity 43 acquiescence for anniversary authorised artefact aural 3 months of the alive actuality face-lifting date. If a artefact contains added than one active, an Commodity 43 appliance is adapted aural 3 months of the face-lifting of anniversary alive actuality in the product. Whilst the appliance allegation consistently be submitted aural 3 months of alive actuality renewal, in assertive affairs the abstract Registration Report may be delayed due to either:

NOTE: HSE cannot affair any authorisations for articles advised to the old endpoints afterwards the face-lifting Date of Application. Please buck this in apperception if you are appointment a non-renewal appliance abutting to the accepted face-lifting of an alive substance. Please accredit to the advice for added details.

Authorisation holders should accomplish all face-lifting applications for their articles absolute a accurate alive actuality at the aforementioned time and at the latest by the appliance deadline. Applications should accommodate the following:

The accoutrement letter or appliance overview should summarise what has been supplied and briefly detail how the artefact portfolio is actuality accurate through the face-lifting action (this should accommodate highlighting accident envelopes and abstracts admission agreements).

It should highlight whether there is any aberration in the alive actuality cachet in GB and NI. If the face-lifting dates and requirements are the aforementioned in both territories, we would aim to affair a distinct authorisation accurate in both territories. Breadth alteration is all-important and the artefact is actuality accurate in both territories, we may crave a added application. Please agenda that applications for NI alone may still chase the zonal and alternate acceptance processes.

The appliance overview should summarise anniversary breadth of the accident appraisal anecdotic what has afflicted and accordingly which areas of the accident appraisal acquire been updated.

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A completed face-lifting appliance anatomy (CRD-R) for anniversary artefact is required. Please agenda that the anatomy allows for the admittance of absolute identical (back-to-back) articles and Extensions of Authorisations for Accessory Use (EAMUs) that are accurate aural the face-lifting abstract Registration Report (dRR).

The appliance anatomy includes two declarations beneath Part C the aboriginal apropos to acquiescence of the use(s) with altitude in the Approvals Register for the alive actuality and the added apropos to acquiescence of the antecedent of the alive substance. Both declarations allegation be accepted for anniversary product. A description of how to actuate acquiescence with the added acknowledgment (relating to abstruse material) can be begin in Abstruse Specification at Face-lifting advice Articles which cannot amuse both declarations are disqualified for the face-lifting action or Art 43.6 Cat 4 extension.

A abstract characterization for anniversary artefact is required. There should be no change to the diction of this certificate from that which was ahead authorised (other than to reflect GAP changes all-important to abutment a satisfactory accident assessment).

Applicants allegation authenticate admission to, or match, the accordant alive actuality abstracts relied aloft during the face-lifting of the alive substance.

Applicants may authenticate admission by providing:

Unless the acquiescence is codicillary alone on the alive actuality abstracts relied aloft for approval or on a letter of admission to such data, a table in the actual architecture allegation be submitted (see links below).

Please use the arrangement for the abstraction account in Commodity 43 applications. This allegation accommodate evidence/ absolution that the new abstracts provided (or to be submitted if Cat 4 applies) are all-important as a aftereffect of abstracts requirements, endpoints or advice abstracts that were not in force back the authorisation of the PPP was granted.

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Renewal requires the artefact accident appraisal to be adapted to reflect new abstracts requirements and new belief (for example, endpoints, guidance).

New abstracts requirements will administer to the majority of face-lifting applications submitted from 2020 onwards, accordingly the new dRR architecture applies. A actual few new dRRs may be in acknowledgment to an AIR 2 alive actuality renewal. In these affairs the old architecture dRR charcoal acceptable, although is about not preferred.

You can use theses dRR templates

HSE will abide to acquire dRRs able for a zonal acquiescence in the axial breadth (or interzonal submission, if relevant) (that is a amount abstracts added civic addenda).

What the dRR should include

A complete dRR absolute a abounding artefact accident appraisal is required. However, the absolute accident appraisal alone needs afterlight breadth the abstracts requirements or belief acquire changed.

A arbitrary should be provided at the alpha of anniversary breadth of the dRR (this may be similar/ the aforementioned as the arbitrary for the accordant accident appraisal breadth in the appliance overview and detail what has afflicted and what needs to be reconsidered). Breadth sections of the accident appraisal acquire been adapted this should be acutely articular either by highlighting the adapted sections or by greying out the sections that acquire not been updated. It should be explained back and by whom anniversary breadth of the appraisal was undertaken (Regulatory ascendancy or applicant). You can use theses dRR templates.

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HSE encourages authorisation holders to abutment the face-lifting of absolute extensions of authorisation of accessory use (EAMUs) aural their dRR. If accomplishing so they should alluringly be articular in B0 as EAMUs. They should additionally be accent on the accordant breadth of the appliance form. In these affairs it is afflicted that the authorisation holder (or applicant) accepts that EAMU fees will be activated (in accession to the artefact appraisal fee). Please agenda that we admonish growers/ agriculturalist groups to liaise with authorisation holders apropos their face-lifting plans. If the authorisation holder does not abutment the use at renewal, growers/ agriculturalist groups can administer for face-lifting after (although they will be adapted to authenticate adapted abstracts access). Abstracted advice on face-lifting of EAMUs by growers is available.

This is adapted if the artefact contains a applicant for substitution.

Note that if authoritative back-to-back articles are accent in the appliance anatomy and these acquire altered authorisation holders again any belletrist of admission allegation awning all requested companies.

HSE will allegation face-lifting applications according to the accepted modular fee system. Applications which appeal a delayed acquiescence of the acknowledging dRR (mixed actives / Cat 4 data) will initially be answerable fees to awning the assignment adapted at this date of the appraisal (including the acquiescence checks). The abounding appraisal fee will be bent and invoiced back the complete dRR is submitted.

Where, for affidavit above the ascendancy of the holder of the authorisation, it is not accessible to achieve on the Commodity 43 artefact face-lifting appliance aural 12 months of the date of appliance of the face-lifting of the alive substance, HSE will extend the absolute artefact authorisations to acquiesce time for the face-lifting appraisal to be completed. This addendum will administer breadth a delayed acquiescence of the dRR has been agreed on the base of Class 4 data, or due to alloyed alive substances expiring aural 12 months of one another. It will additionally administer where, for affidavit of abridgement of ability availability, we are clumsy to complete the appraisal aural the timelines.

To abstain accepting to again extend the authorisation due to alteration accepted achievement dates, HSE will extend the afflicted authorisations already and alter the absolute accomplishment date with the afterward wording:

‘This authorisation charcoal actual until a authoritative accommodation is taken beneath the advancing appliance for face-lifting of this artefact beneath Commodity 43 of Regulation (EC)1107/2009 (and aloft the action that a complete abstracts is supplied by the acquiescence date agreed by HSE) unless an beforehand accommodation is taken. Aloft accomplishment of this authorisation there will an added 6-month adroitness aeon for the auction and administration of absolute stocks and a added 12-month adroitness aeon for the disposal, accumulator and use of absolute stocks. Back this accommodation is taken, a abandonment apprehension allegorical the adroitness aeon will be published.’

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If no acquiescence is fabricated by the agreed date, the authorisation will be anon aloof (subject to the Commodity 46 adroitness period).

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Agreed Upon Procedures Report Template

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