Veterinary medicinal products placed on the EU and NI markets before 1 January 2021
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
Continued circulation of veterinary medicines placed on the market before 1 January 2021
Article 41 of the EU Withdrawal Agreement permits any goods lawfully placed on the UK or EU markets before 1 January 2021 to be further made available on these markets and circulate between the two until it reaches its end-user. This includes medicines moving from GB to NI, NI to EU and GB to/from EU.
A medicine is ‘placed on the market’ if it is available for sale or supply and there has been a written or verbal agreement (or offer of an agreement) to transfer ownership of the medicine to another legal entity.
The placing of a manufacturing order is insufficient to qualify for continued circulation as the medicine must have been manufactured and Qualified Person (QP) certified and released.
Medicines with an MA in the country of destination that meet these criteria, which include those already in the supply chain and stored by a wholesaler in the UK or EU (who has been sold or supplied the medicines), can continue to move between the UK and EU markets without the need for repeating batch (QC) testing and QP certification/release to meet import or export requirements.
Medicines placed on the market by 11pm on 31 December 2020
To qualify for continued circulation between the GB, NI and EU markets, batches of medicines must be placed on the market before 11pm on 31 December 2020, which means:
- manufactured
- certified and released by a QP
- made available for sale or supply in the manufacturer’s stock management system
Additionally, again before 11pm on 31 December 2020, either:
- the medicine must have transferred ownership by sale or supply to another legal entity, or
- an offer to either purchase or take ownership of the medicine must have been made to the manufacturer by another legal entity. Where there is an offer, the actual transfer of ownership may take place after 11pm on 31 December 2020
This may include transfer of stock for sale or supply to different legal entities in the same company group.
Evidence for qualifying products moving from GB
From 1 January 2021, before selling or supplying a veterinary medicine from GB to NI or the EU, the manufacturer or wholesale dealer must confirm that it has been ‘placed on the market’ as described above, before 11pm on 31 December 2020.
Evidence can include providing to the supply chain a written statement to confirm that ownership has transferred by sale or supply to another legal entity, or an offer to take ownership had been made, before 11pm on 31 December 2020.
Wholesale dealers who hold stock, have (or have offered to) purchase or take ownership of veterinary medicines before 11pm on 31 December 2020, may need to obtain evidence of this from the manufacture. In some cases, the wholesale dealers’ own records may also be acceptable evidence.
There is no need to evidence products moving from the EU to GB as we will continue to recognise EU batch (QC) testing and QP certification/release until January 2023. Also, there are no import or export requirements for product movement between the EU and NI, or from NI to GB.
Potential scenarios for the GB Manufacturer
If, by 11pm on 31 December 2020, a batch has been QP certified and released and is in the EU, GB or NI manufacturer’s warehouse and:
| Scenario | Scenario detail | Qualified/Not qualified | ||
|---|---|---|---|---|
| Scenario 1 | is ‘on hold’ in the warehouse inventory system, perhaps for stock management reasons | Not qualified. This medicine has not been placed on the market, as it is not available for sale or supply in the stock management system therefore the qualifying criteria have not been met. EU importation rules will apply for products moving from GB. | ||
| Scenario 2 | is marked as available for sale or supply in the warehouse system; no offer has been made by another legal entity to the manufacturer to take ownership of the medicine | Not qualified. This medicine has not been placed on the market as there is no offer of purchase or ownership transfer therefore the qualifying criteria have not been met. | ||
| Scenario 3 | is marked as available for sale or supply in the warehouse system; the ownership of that medicine has been transferred to the affiliate in the EU, GB or NI which is a separate legal entity from the original owner; the medicine is still physically located in the EU, GB or NI manufactures’ warehouse. | Qualified. This medicine has been transferred to a different legal entity and qualifies for provisions under Article 41 therefore it can be supplied from 1 January 2021 without the need to meet EU importation rules for products moving from GB. | ||
| Scenario 4 | is marked as available for sale or supply in the warehouse system; a separate legal entity to the manufacturer has offered to either purchase or take ownership of the medicine; the sale or transfer of ownership is not complete. | Qualified. This medicine has an offer to purchase or take ownership and qualifies for provisions under Article 41 therefore it can be supplied from 1 January 2021 without the need to meet EU importation rules for products moving from GB. | ||
| Scenario 5 | ownership of the medicine is transferred to a different legal entity in the EU; the batch is pre-allocated to supply the NI market | Qualified. This medicine has been transferred to a different legal entity and qualifies for provisions under Article 41 therefore it can be supplied from 1 January 2021 without the need to meet EU importation rules for products moving from GB. | ||
| Scenario 6 | is marked as available for sale or supply in the warehouse system; ownership of the medicine was transferred to a different legal entity before the end of the transition period; ownership is then transferred back to the manufacturer. This second transfer of ownership can take place at any time. The medicine remains in the same physical location throughout | Qualified. This medicine had been transferred to a different legal entity and qualifies for provisions under Article 41 therefore it can be supplied from 1 January 2021 without the need to meet EU importation rules for products moving from GB. |