Structure Of A Notice Of Authorisation
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
What does a Notice of Authorisation specify?
Authorisation documentation for commercial authorisations (including Parallel Trade Permits), Trials Permits or Extension of Minor Use (EAMU)will consist of a letter and a 'Notice of authorisation'. The Notice of authorisation will specify the following (applies to any authorisation unless specifically stated):
- The governing legislation for the authorisation,the level of authorisation and whether authorisation is for sale, distribution, disposal, storage and use or any combination of these.
- The product identity, including its tradename and registration (MAPP) number.
- Details of your product's formulation including formulation type, and quantity/identity of the active substance(s). For a commercial authorisation (not Parallel Trade Permit) full details of the a.s. manufacturing source and formulation recipe are also given in the confidential appendix 3 see (t) below).
- You can only market your product if it consists of this formulation and you must submit an application for a new authorisation if you wish to change the formulation in any way
- For a 'Parallel Trade Permit, details of the product being sold in another Member State which you are importing into the UK .
- The authorisation holder and marketing company for your product. If these are identical, the marketing company will not be specified.
- The relevant date(s) of expiry for the authorisation.
- For a Trials Permit, the amount of product that can be applied and the maximum area that can be treated on an annual basis.
- For a commercial level of authorisation(not Parallel Trade Permit), a reference to the draft product label (date of submission and HSE reference).The accompanying letter will provide details of the changes required to the draft label in order that your product can be placed on the market in accordance with the authorisation and the underlying safety and efficacy assessment.
- For a Parallel Trade Permit, a condition is set that your label must comply with that of the reference product..
- For a commercial level of authorisation, the size, material and design of the packaging authorised for your product.
- Details of any additional conditions of storage or advertisement required for your product.
- Details of the conditions of use which will include:
- The field of use. This will specify whether your product is authorised for use by amateur or professional users,the purpose for which the product is intended (eg use as an herbicide) and whether it can be used in aerial application.
- The crops and/or situations on which your product can be used.
- If necessary, the maximum individual and maximum total doses for specific crops and/or situations.
- If necessary, the maximum number of treatments for specific crops and/or situations.
- If necessary, the latest time of application for specific crops and/or situations.
- The requirements for the protection of users of your product.
- The requirements for the protection of the environment with the use of your product.
- Any other restrictions that need to be specified for the use of your product eg a maximum concentration for the use of your product on an individual crop.
- Details of your obligations with regard to adverse data.
- The COP number for your application.
- A unique number for your Notice of authorisation.
- Details of any authorisation(s) superseded (or being replaced) by the new authorisation.
- For an EAMU, advisory information on the use of the product under the EAMU.
- A 'general conditions' section to reinforce the authorisation holder's obligations with regard to labelling, packaging, mixing, adverse effects and the provision of information.
- A 'confidential conditions' section relating to active substance and formulation detailing what constitutes the authorised formulation. In addition to the existing technical specification reference, the data owner(s) of each source of active substance will be specified. Where there are no issues relating to 3rd party confidentiality, the full formulation details of the authorised product will also be stated. For parallel imports, 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 Notice published on the website.