GovWire

Detailed guide: From 1 January 2021 MAH and Authorised Personnel Location

Veterinary Medicines Directorate

November 25
16:08 2020

Marketing Authorisation Holder Location (updated 25/11/20)

Centrally authorised Marketing Authorisations

Centrally authorised Marketing Authorisations (MAs) are issued by the European Medicines Agency which must comply with EU Regulations and as such the MA Holder (MAH) must be located in the EU for these products to be on the NI market.

For existing Centralised MAs, you will be offered a GB MA for these products from 1 January, see below and Application and Authorisation process. If your MAH location is in the EU for these new GB MAs, we will continue to accept that for batches placed on to the GB market before 1 January 2023. We are considering the arrangements for post 2023 and will provide further information in due course. We recommend waiting for these additional details before making MAH location changes to meet GB requirements.

Mutual Recognition and Decentralised MAs

MAs issued following Mutual Recognition/decentralised procedures will continue to be issued by the VMD in respect for NI. Due to interpretation of the MAH location requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2) for authorisations issued by the UK in respect of NI, the MAH can be located in GB or NI for the product to be on the GB and/or NI markets. Therefore:

  • To market in NI: MAH location can be in GB, NI or the EU

  • To market in GB: MAH location can be in GB or NI and we will also continue to accept an EU location for batches of these products placed on to the GB market before 1 January 2023. We are considering the arrangements for post 2023 and will provide further information in due course. We recommend waiting for these additional details before making MAH location changes to meet GB requirements.

Existing UK national MAs

Due to interpretation of the MAH location requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2) for authorisations issued by the UK in respect of NI, the MAH can be located in GB or NI for the product to be on the GB and/or NI markets. Therefore:

  • To market in NI: MAH location can be in GB, NI or the EU
  • To market in GB: MAH location can be in GB or NI and we will also continue to accept an EU location for batches of these products placed on to the GB market before 1 January 2023. We are considering the arrangements for post 2023 and will provide further information in due course. We recommend waiting for these additional details before making MAH location changes to meet GB requirements.

GB MAs

For MAs valid only in GB, the MAH can be located in GB or NI. We will also accept an EU location for batches of these products placed on to the GB market before 1 January 2023. We are considering the arrangements for post 2023 and will provide further information in due course. We recommend waiting for these additional details before making MAH location changes to meet GB requirements.

NI MAs

For MAs valid only in NI (national procedure), the MAH can be located in GB, NI or the EU.

Qualified Person for Pharmacovigilance (updated 07/10/20)

Centrally authorised Marketing Authorisations

Centrally authorised Marketing Authorisations (MAs) are issued by the European Medicines Agency which must comply with EU Regulations and as such the Qualified Person for Pharmacovigilance (QPPV) must be located in the EU for these products to be on the NI market.

For existing Centralised MAs, you will be offered a GB MA for these products from 1 January, see below and Application and Authorisation process. For GB MAs, the QPPV can be located anywhere.

Mutual Recognition and Decentralised MAs

MAs issued following Mutual Recognition/decentralised procedures will continue to be issued by the VMD in respect of NI. Due to interpretation of the requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2) for authorisations issued by the UK in respect of NI, the QPPV can be located in the EU, NI or GB.

UK national MAs (existing), GB MAs and NI MAs

Due to interpretation of the requirements of the Northern Ireland Protocol (reference: Section 20 of Annex 2) for authorisations issued by the UK in respect of NI, such as existing UK wide and NI MAs, the QPPV can be located in the EU, NI or GB.

The QPPV for GB MAs can be located anywhere.

Named Distributor (updated 25/11/20)

We will continue to recognise EU locations for named distributors for batches of products placed on the GB market before January 2023.

Manufacturing sites, Batch (Quality Control) Testing and Qualified Persons (updated 25/11/20)

MAs authorised via EU Mutual Recognition, Decentralised and Centralised procedures

The Northern Ireland Protocol mandates that for NI, a veterinary medicine authorised via EU Mutual Recognition, Decentralised or Centralised procedures, must comply with EU Regulations. Therefore, from 1 January 2022, unless the product is manufactured and certified/released by a qualified person (QP) located in NI or the EU, it must be imported into NI (or EU) via an authorised Manufacturing/Importation (ManA) site (also known as an MIA site) for subsequent batch (QC) testing and QP certification/release. This also applies to these products moving from GB to NI.

MAs authorised via a UK national procedure only and valid in GB and/or NI

For nationally authorised MAs we will continue to recognise manufacturing sites, sites of product batch (QC) testing and sites of QP certification/release located in the EU for batches placed on to the GB market before 1 January 2023. We are considering the arrangements for post 2023 and will provide further information in due course. We recommend waiting for these additional details before making changes to meet GB requirements.

Veterinary medicines manufacturers in the UK, whether manufacturing products for domestic use or export, must possess a valid manufacturing/importation authorisation (ManA) which names a QP who meets the required qualifications/experience. The QP can be located anywhere but must be permanently and continuously at the ManA holders disposal and they can be removed from the ManA for failing to fulfil their role/responsibilities.

We will also continue to recognise a manufacturing site located in a country with which the UK

Related Articles

Comments

  1. We don't have any comments for this article yet. Why not join in and start a discussion.

Write a Comment

Your name:
Your email:
Comments:

Post my comment

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: