Maximum Residues Limits (MRL)
Guidance for the veterinary pharmaceutical industry on applying for maximum residue limits (MRLs) in the UK.
Maximum Residue Limits in Northern Ireland
Under the Northern Ireland Protocol, NI will operate under EU rules. This means that Maximum Residue Limits (MRLs) set by the European Commission must be used for products authorised in NI.
You must submit the same application and all procedurally related communications that you provide to the EU to us via VMDS or Eudralink within 2 working days.
Maximum Residue Limits in GB
MRLs listed in Commission Regulation (EC) 37/2010 or published in the Official Journal prior to 31 December 2020 will continue to have effect in GB and included on the list of GB approved MRLs from 1 January 2021.
For MRLs in GB, you will need to apply to the VMD, via VMDS or Eudralink, to:
- establish new MRLs for pharmacologically active substances
- extend an existing MRL, for example same substance but different species and/or food commodity
- change an existing MRL
Applications and data requirements
Before you apply, we recommend that you discuss your proposed application with us. To arrange a meeting, email postmaster@vmd.gov.uk and include ‘Request a company meeting’ in the subject line.
When you are ready to apply you will need to submit, through our Digital Service (VMDS), an application form and the information set out in Commission Regulation (EC) 2018/782 in the format set out in Commission Regulation (EC) 2017/12.
Commission Regulation (EU) 2017/880 sets out the principles and minimum criteria for the extrapolation of an MRL to either another foodstuff from the same species or to the same foodstuff from another species. You should submit the MRL application at least 6 months before an associated Marketing Authorisation application.
Validation
Applications are validated upon receipt to check that everything has been provided in order to begin the assessment.
It is up to you to identify and submit all the necessary information in support of your application. If the submission is incomplete, we may not be able to progress your application.
Fees
The application fee to establish an MRL in GB is set out in legislation as being £62,300, based on the current EU fee. However, we will administratively reduce this to £15,000 and, in accordance with our cost recovery principles, this fee will be reviewed in 12 months in light of our experience.
The fees for making amendments (including extensions) to currently approved MRLs is set out in legislation as being £20,103, based on the current EU fee. However, we will administratively reduce this to £5,390 and, in accordance with our cost recovery principles, this fee will be reviewed in 12 months in light of our experience.