Secretariat Procedures: Application Streams

Secretariat Procedures: Application Streams

Applications accepted by the Chemicals Regulation Directorate (CRD) are placed in processing streams, grouped together on the basis of the type and amount of work involved in the evaluation. There are various processing streams, outlined below.

Product streams

The following product applications are co-ordinated by CRD's Registration Branch.

admin experimental

Applications for experimental/trials work to be carried out under strict conditions. No technical input is required.

admin

Applications for new approvals, or changes to existing approvals, where no technical input is required. Includes applications for own-use parallel imports.

no-data

Applications requiring technical input (including consideration of cases submitted in lieu of data), but no data evaluation. Includes applications for parallel imports.

data

Applications requiring data evaluation in one or two specialist areas. Includes applications for Mutual Recognition.

data-plus

Applications requiring data evaluation in three or more specialist areas. Includes applications for provisional to full approval under COPR and re-registration applications following Annex I inclusion.

major change

Applications for a major change of use for an existing active substance or for an experimental approval for a new active substance which require consideration by other Departments and/or the ACP. These are usually termed 'Departmental' applications.

Within each stream, applications for the following can be considered:

• commercial approval
• experimental approval
• extension of use (Specific Off-Label Approvals (SOLAs))
• adjuvant authorisations

New active substances and EU review streams

Applications for products containing an active substance that is either new to the UK or EU are also processed and co-ordinated by CRD's Registration Branch. CRD determine whether the product can be provisionally approved in the UK prior to Annex I inclusion. The UK can also act as Rapporteur Member State (RMS) for the assessment of whether an active substance can be included on Annex I of Directive 91/414. The evaluation process will include consideration by the Advisory Committee on Pesticides (ACP). For active substances new to the EU, Annex I inclusion is assessed at the EU level.