Applications that we accept are placed in different processing streams, depending on the type of authorisation requested and the data/information submitted.
What are the targets for new active substance and EU Review applications?
Applications for new active substances and EU Reviews are processed by the Registration Branch.
There are also ‘milestones’ for the completion of work relating to EU reviews and new active substances being considered for approval under Regulation (EC) 1107/2009. You will be informed of the relevant milestones by the project manager.
If you have any questions relating to the targets and milestones for these types of application you should contact our Registration Branch.
What are the streams and targets for product applications?
There are a number of different streams for product applications, the choice of which is dictated by the type of application and the data and/or information provided. Your application will be allocated to the appropriate stream following consideration at the weekly Registration Branch Applications Sift. Within each of the ’Admin’, ‘No-Data’, ‘Data’ and ‘Data-Plus’ streams, we consider applications for commercial authorisation, experimental permits, extensions of use, parallel trade permits and adjuvant listing. The streams are summarised below:
Application streams and targets | Stream | Explanation of application type | Target for completion |
| ‘Admin Experimental’ | - Applications for experimental/trials work to be carried out under strict conditions
- No technical input is required
| 1 week |
| ‘Admin’ | - Applications for new commercial authorisations, or changes to existing authorisations, where no technical input is required
- Includes own-use parallel permits
| 4 weeks |
| ‘No-Data’ | - Those requiring technical input (including consideration of cases submitted in lieu of data), but no data evaluation
- Includes parallel trade permits
- Includes emergency extensions of use (regardless as to whether data are submitted)
- Includes the first stage of two-staged applications where no data are submitted
- Includes product applications where the request is solely for a technical equivalence assessment
| 9 weeks |
| ‘Data’ | - Those requiring data evaluation in one or two specialist areas
- Includes applications for mutual recognition (for which no data would be submitted)
- Will also include the first stage of two-staged applications where data have been submitted
| 18 weeks |
| ‘Data-Plus’ | - Those requiring data evaluation in three or more specialist areas
- Includes applications for provisional to full authorisation for proucts previously authorised under COPR
- Includes applications for re‑registration following Annex I inclusion
| 30 weeks |
The eight specialist areas by which data are categorised are as defined for charging purposes i.e. product/active chemistry; residues; toxicology; operator exposure; ecotoxicology; environmental fate and behaviour; and finally efficacy and crop safety.
The choice of streams is dictated by the amount of data provided, although there are some exceptions:
- Applications for upgrading from provisional to full authorisation (PA to FA) for products previously authorised under COPR will be processed in the Data-Plus Stream, with a target of 30 weeks, regardless of the amount of data provided.
- Applications for re-registration (both existing and new active substances) will be processed in the Data-Plus Stream, regardless of the amount of data provided.
- Applications for mutual recognition will be processed in the Data Stream, with a target of 18 weeks.
- Own use parallel permit applications will be processed via the Admin Stream, even though technical input is required.
- Applications for authorisation following a zonal submission in the ZRMS, known as following zonals, will be processed via the data stream with a target of 18 weeks
- Applications for the first stage of a two-staged application are placed in either the No Data or Data Stream, whilst the second stage will be placed in either the No-Data, Data or Data-Plus Stream depending on the amount of data submitted. The second stage will be subject to the full target cost for that stream.
- Some applications must be dealt with as emergencies, and are eligible for priority processing. There are strict criteria which apply to the acceptance of emergency applications, full details of which are given in the guidance document on emergency (120 day) authorisations. We will prioritise these applications to achieve the earliest possible completion date.
- Fast-tracking. The emergency procedures described above do not apply where there is a commercial need to launch a new product or use. However, in recognition that applicants may wish to ensure early market entry, we offer an option to allow approval holders to ‘fast track’ applications.
How can I fast-track an application?
Each authorisation holder can request fast-tracking of one application in either the Data or Data-Plus streams each financial year. This reduces the completion target by 9 weeks in the Data Stream (to 9 weeks) or 12 weeks in the Data–Plus Stream (to 18 weeks).
Authorisation holders (or the applicant if different) must request fast-track status when submitting their application. This can be done by clearly stating the request in the covering letter and by ticking the fast-track status box (PART C/11 of CRD1). It will not be possible to fast-track the application after it has been accepted or mid-evaluation.
Applications in the Admin, No-Data or New active EU Review applications cannot be fast-tracked. In addition applications such as provisional to full authorisation for products previously authorised under COPR, re-registration applications (including first registration of an active substance following Annex I inclusion/approval a new product) and applications for which a 'zonal surcharge' has been applied cannot be fast-tracked. The allocation of fast-tracks will ultimately be at CRD's discretion.
What are the targets for applications for import tolerance and official recognition?
These applications are not included in the application types/streams outlined above, but they are subject to completion targets, which vary according to the type of submission. For full details of the processing targets for import tolerance applications, please see the guidance document on import tolerances. Processing targets for official recognition are available in the Applicant Guide.
How do I find out the target and what might impact upon the processing time?
We will inform you of the target date for completion of your application once it has been accepted at the weekly sift (except for admin applications where the short processing time makes this impractical).
For some applications we may need to seek further information from you. Any time spent seeking further information does not count towards the processing time of your application. When we request further information we highlight that any time required to address these issues will be added to the original target date to give a revised completion date.
If we need to seek further information from another Member State to enable us to continue with the evaluation. The time awaiting this information will not count towards the processing time for your application.
Where we seek comments from other Member States on our draft assessment, the application will be suspended for either 2 or 6 weeks for no data stream and data/ data plus stream applications, respectively.
For parallel trade permit applications, we need to seek confirmation of formulation details from other Member States. This does not count towards the processing time of your application.
