knoell in the UK
With Dr. Knoell Consult and Cyton Triveritas we've got you covered in the United Kingdom.
Crop Protection, Chemicals & Biocides
Dr. Knoell Consult Ltd. provides services mainly for registration of chemicals, crop protection products and biocides. Working with both European and non-European clients, the small but very experienced team is perfectly set-up not only to support you with in the traditional markets, but also to guide you through the uncertain times of a regulatory landscape post Brexit (also see our post-Brexit regulatory summary below).
Dr. Knoell Consult Ltd.
22 Cathedral Road | Cardiff CF11 9LJ
Cyton Biosciences Ltd.. specialises in the registration of veterinary pharmaceuticals and animal feeds.
Cyton Biosciences Ltd.
68 Macrae Road Eden Office Park Ham Green | Bristol BS20 0DD
Triveritas joined Cyton in 2020 and complements our services with their proven track record of conducting global veterinary clinical trials to GCP and VICH standards. Triveritas have over two decades' experience supporting client companies in the areas of veterinary regulatory affairs, scientific writing and global project management.
Bank Barn | How Mill | Brampton CA8 9JY
Now that the UK has left the EU and the implementation (or transition) period during which the UK has been following EU rules and regulations ends on 31 December 2020, there will be consequences for companies manufacturing or importing into the UK. However, to what extent your products might be affected depends on the regulatory framework that applies.
A standalone chemicals regulation, commonly referred to as UK REACH, will come into force from 1 January 2021 in Great Britain (GB: England, Scotland, Wales). Under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021: (EU) REACH will still apply. UK REACH will be administered by the UK’s Health & Safety Executive (HSE). UK REACH is closely based on (EU) REACH but will be an entirely separate regulatory regime so may diverge in future. Transitional arrangements to allow companies to comply with UK REACH will apply during 2021 and for some years thereafter.
Consequences of this include:
- Substances which are manufactured in or imported into both GB and EU would require two separate registrations, under both UK REACH and (EU) REACH.
- GB companies purchasing substances from the EU, even though these substances are registered under (EU) REACH, will become importers under UK REACH with obligations to register the substances in GB. These obligations could be alleviated if the EU supplier were to appoint an Only Representative (OR) based in GB.
- Companies based outside the EEA using an OR who is based in GB to cover imports into the EU will need a new OR based in the EU. Conversely, companies based outside the EEA using an OR based in the EU to cover imports into GB will need a new OR based in GB. In short, non-EEA/non-GB companies may need two ORs: one for GB and one for the EU!
- There will also be standalone GB regulations corresponding to CLP and PIC.
With affiliates based in GB and EU, as well as many years of experience acting as OR for non-EEA companies selling into the EEA, knoell is well placed to support clients in maintaining their business and fulfilling their regulatory duties once UK REACH comes into force.
Download our factsheet here.
We can act as OR...
From 1 January 2021, the EU biocides legislation (BPR) will no longer apply if your biocidal products or active substances are placed on the GB market. As mentioned above, under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021.
Similar to the consequences outlined for Chemicals above,
- GB based companies will have to apply to the UK HSE if they wish to apply for an active substance to be approved, or for a biocidal product to be authorised, in GB.
- GB based manufacturers or suppliers of biocides/biocidal products wishing to market within the EU have to either be located in the EU or have an appointed EU-based representative to be listed in Article 95 list of substances and suppliers. A GB version of the EU list of approved active substance suppliers will be created and operate in parallel to the EU Article 95 list from 1 January 2021.
- EU or non-EEA manufacturers and suppliers selling into GB will require either a company located in GB or a representative to obtain authorisation via UK HSE.
We can help you make appropriate contingency plans based on your individual circumstances and then be ready to support you with the new separate regulatory regime.
Plant Protection Products
Most recent information available states that from 1st January 2021 the current EU regulatory regime for Plant Protection Products (PPPs) will be converted into GB-wide regulations which will remain very similar to the existing EU regime. As mentioned above, under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021 and EU PPP legislation will continue to apply. After this point, EU decisions on active substances and Maximum Residue Levels (MRLs) will no longer apply to GB. HSE will continue to act as the national regulator UK-wide and will make its own decisions on active substance approvals, PPP authorisations and set MRLs based on its own assessments. Applicants will need to make separate applications under the GB and EU regimes to obtain access to both markets. There will be a GB list of approved active substances and MRLs.
Existing PPP authorisations remain valid in GB until their current expiry date.
|In contrast to other regulatory frameworks (e.g. Chemicals and Biocides), companies will not need local representation to obtain authorisation for their active substances and products in GB or EU. Also, the current active substance approvals, PPP authorisations, and Maximum Residue Levels (MRLs) will remain valid in GB and EU after exit day and therefore immediate action is not required.|
To date, the following major changes are known for the Veterinary Medicines market:
- Following the UK’s exit from the EU, UK-based companies can no longer hold Marketing Authorisations for Veterinary Medicinal Products marketed in EU Member States. These include nationally authorised products but also so-called ‘Community authorisations’ licensed via the Centralised, Decentralised or Mutual Recognition procedures.
- The Veterinary Medicines Directorate (the VMD – the UK agency) can no longer act as RMS for European Marketing Authorisation Application procedures, and for Veterinary Medicine Products (VMPs) already marketed in the EU where the UK acted as RMS, this responsibility will need to be transferred to the authority of another Member State.
- Since the incentives available for Minor Use, Minor Species (MUMS) products are a European Union initiative, it will be necessary for UK-based licence holders to transfer MUMS products to European companies in order to continue to avail of the incentives.
- It has not yet been clarified how the exact requirements for Qualified Persons will change. However, as is the case for holding EU Marketing Authorisations, batch release for the EU market will no longer be possible from a UK address and this function will need to be transferred.
|With headquarters in Bristol, UK and a new office in Mannheim, Germany, knoell's affiliate Cyton can continue to offer all services in regulatory affairs and product development, in both regions, regardless of the final outcome of the Brexit negotiations. For further information have a look at the knoell Animal Health team's UK beyond Brexit overview and also check their separate Brexit news page.|