New guidance on Supply of Medicines into Northern Ireland

Following the MHRA Medicines Supply to Northern Ireland Webinar at the start of February, the JensonR+ team have created a summary of the key changes and impacts for industry for medicinal products.

1. National UK-wide authorisation (including Northern Ireland) applications permitted in parallel to MR/DC applications

Prior to this announcement, the EU position was that Northern Ireland is classed as part of the EU with respect to marketing authorisations, therefore if you wanted a marketing authorisation for Northern Ireland,  and the applicant had an existing MA or DCP application elsewhere in the EU, you needed to add it to an existing Mutual Recognition/Decentralised procedure (MRP/DCP).

This was very off-putting for applicants as it meant paying a separate fees for Northern Ireland and Great Britain (England, Scotland and Wales) and lead to separate licences being granted which leads to potential future issues with harmonisation of information.

This new development means that the EU has will permit whole UK (Northern Ireland and Great Britain) national authorisations whilst MR/DC procedures are in place. There are also mechanisms for withdrawing Northern Ireland out of a pending or existing DCP/MRP so the Great Britain authorisation can be converted to a UK-wide authorisation

2. Bridging period for Northern Ireland when Centrally Authorised Product authorisation under assessment but approved in Great Britain

Whilst Northern Ireland can be withdrawn out of an existing MRP/DCP, this does not apply to centrally authorised products (CAPs) as the scope of the community authorisation applies to Northern Ireland.

However, as CAPs are no longer valid in GB and a separate national application is needed for GB, there is a possibility that in the case of parallel applications to EC and MHRA, that the MHRA will approve the application first.

The EU is proposing to amend their regulations to allow the MHRA to permit temporary authorisation of the product in Northern Ireland for 6 months until the community authorisation is granted.

3. UK Marketing Authorisation Holder permitted for Northern Ireland (other than for Centrally Authorised Products)

Prior to this announcement, the EU position was that for all cases where Northern Ireland is involved in an authorisation (including UK national or Northern Ireland as part of an MRP/DCP), the Marketing Authorisation Holder (MAH) must be based in EU (outside of temporary derogations); whilst the UK position was that a UK based MAH was permitted for Northern Ireland.

Now both the EU and UK are aligned that the MAH for a UK authorisation involving Northern Ireland can be located in the UK. But please note that this does not apply for CAPs, in this case the MAA holder for Northern Ireland must be located within the EU.

4. Medicinal Products can continue to be supplied into Northern Ireland without an MIA

Holders of an appropriately authorised WDA located in Northern Ireland can continue to import medicinal products from GB providing that:

  • Products are authorised in Northern Ireland
  • Products have undergone batch testing in EU or UK
  • Batches have been certified and released by a QP in EU or UK
  • Packs bear Falsified Medicines Directive safety features (unique identifier and anti-tamper device)
  • Products are only made available in Northern Ireland

This permits continued supply under the existing temporary derogation for Northern Ireland (but is now permanent).

5. Qualified Persons for Pharmacovigilance can be Located in GB for Northern Ireland Licences

The EU have now agreed that Qualified Persons for Pharmacovigilance (QPPV) can now be located in GB for authorisations valid in Northern Ireland for an MRP/DCP authorisation. This was previously not permitted by the EU but was permitted by the MHRA. However, a caveat to this is that if the MAH has a QPPV established in the EU, then they must be the designated QPPV for Northern Ireland.

6. Qualified Persons and Batch Testing can be located in GB for Northern Ireland Licences

Qualified Persons for batch certification (QP) can be located in GB for release of product from UK site of batch release for supply of medicines into Northern Ireland (UK national MA or Northern Ireland as part of MRP/DCP).

Batch testing can be carried out in GB provided that batches are certified and released by a QP located in EU, Northern Ireland or GB and that the site of batch testing is appropriately licensed and subject to inspection.

Here at JensonR+ we can help guide and support you on how best to make use of the new guidance to ensure you can continue supply of medicines into Northern Ireland.

CONTACT US

This is the first part of a series of updates from us on the supply of medicines into Northern Ireland. We will be providing a summary of the new Northern Ireland MHRA Authorised Route (NIMAR) shortly.

Ben Smith