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The Applicant Guide: Technical Specifications and Formulation Details

What is a technical specification?

Each source of active substance has a specification which must be authorised. Further details on technical specification are given in: Identity and physical and chemical properties of the active substance and formulation.

What else is in the formulation of a product?

The formulation details of your product consist of the technical specification and the formulation 'recipe'. Further details are given in: Identity and physical and chemical properties of the active substance and formulation.

How is this information presented on the Authorisation?

The Authorisation includes a 'confidential conditions' section relating to active substance and formulation details. This section includes details of each source of active substance (data owner, the site of manufacture (unless confidential) and the HSE document reference for each source) and where there are no issues relating to 3rd party confidentiality, the full formulation details of the authorised product.

For parallel trade permits, information relating to the product authorisation in the country of origin will be specified.

Please note that the confidential section will be removed from the version of the notice published on the website.

How should this information be submitted?

When applying for a commercial level of authorisation, including a permit for trial purposes (except for parallel trade permits), you will need to provide details of the technical specification and formulation recipe for your product.

Part E of the application form CRD1 must be completed, along with the sections referenced, and where relevant a draft registration report and a draft technical equivalence report should be submitted.

Data or reasoned scientific cases to address all the appropriate data requirements must also be submitted (see The Applicant Guide: What Should I Include In An Application).

If you are applying for a new source of active substance, a draft technical equivalence report must be submitted alongside supporting data and covering letter.

What constitutes a change to the technical specification?

Details are given in Identity and physical and chemical properties of the active substance and formulation.

What is a source?

Details are given in: Identity and physical and chemical properties of the active substance and formulation.

How do we assess technical equivalence?

Details are given in: Identity and physical and chemical properties of the active substance and formulation.

What if I want to make changes to my authorised technical specification?

What are the costs and timelines?

Where you are seeking authorisation for a completely new source, standard fees (see CRD Fees for Individual Application Types) will apply (usually sift fee + co-ordination fee + chemistry data module + toxicology case). The evaluation of a change to an existing source, or for a new source will usually be considered as a data stream application.

It is also possible to seek authorisation for changes to the technical specification as part of another application eg new uses, re-registration, new product. In this case standard fees will apply.

If the source has already been considered technically equivalent in another member state, a copy of the technical specification must be submitted in support of an application. CRD will obtain the equivalence report from the evaluating member state to ensure that it supports the submitted specification. These applications will be charged (see CRD Fees for Individual Application Types) a reduced fee (ie sift fee, admin. fee, and a chemistry case fee.

Do I need to submit an application for assessment of technical equivalence at Step 1 of re-registration?

There is no need to submit a 'formal application' at this stage – details of requirements at Step 1 are outlined in our 'General Information On Re-Registration And Step 1.

You must ensure you comply with those requirements or your authorisation may be revoked.

Can I make changes to the source during the transitional period ie before re-registration?

Prior to re-registration it is possible to change your existing national authorisations to reflect changes in source (this is one of the exceptions under the transitional period for both new and existing active substances). You must inform us of changes as soon as possible, and submit an application to support the change. We would assess this in accordance with the Sanco Guidance document.

Further information

Updated 2016-11-09