GovWire

Detailed guide: Veterinary medicinal products placed on the EU and NI markets before 1 January 2021

Veterinary Medicines Directorate

October 28
12:10 2020

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 manufacturers 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 manufacturers 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.
Published 28 October 2020

Recent Comments

Follow Us on Twitter

Share This


Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: