GovWire

Eligible Marketing Authorisations and criteria

Joint assessment is the term used for a procedure where the Irish National Competent Authority (HPRA) and VMD will collaborate on the assessment of a shared mock-up, for use on veterinary medicines marketed in their countries.

Joint assessment of labelling can be achieved between GB and IE, NI and IE or all three - GB, IE and NI. You should also refer to theHPRAguidance.

The products involved in the joint assessment procedure must:

• hold Marketing Authorisations (MAs) in both the UK, or part of, and Ireland, or new national and EU procedure MA applications (as applicable for GB/NI) be submitted to both the VMD and theHPRAat the same time
• be held by the same Marketing Authorisation Holder (MAHs), orMAHsbelonging to the same parent company
• have product information requirements which are the same

To obtain joint assessment, the Summary of Product Characteristics (SPC) and QRD must be identical in the relevant territories. To maintain joint assessment theSPC/QRD must remain harmonised. You can apply either at the end of a new MA procedure or retrospectively for existingMAs, whether authorised by EU or national procedures.

You can opt out of joint assessment, but the UK and Ireland will conduct independent assessments and cannot help you maintain the harmonised nature of the labels/leaflets.

Joint assessment of labels following a new MA procedure

Joint assessment of labels with Ireland can only be carried out as a G.I.15.z VRA.

For new MA applications, if you advise joint assessment of labels is required, the new MA procedure will be closed, and you will need to submit subsequent VRAs to both the VMD and HPRA in parallel, prior to marketing.

Centrally Authorised Products

Mock-ups for Centrally Authorised Products (CAPs) submitted to IE and NI are not assessed by national competent authorities; however they must reflect the agreed QRD text and observe blue box requirements.

Mock-ups submitted in support of an equivalent GB national application will be assessed by the VMD in accordance with our national requirements and standard 20 day timetable.

Introducing joint assessment for existing MAs

You should simultaneously submit a U.II.z.d VRA to the VMD and a G.I.15.z VRA to the HPRA. You should make it clear in your application that the purpose of the variation is to achieve joint assessment of labels.

The QRD for the products involved may not be the same, so these will need to be harmonised first before labels can be assessed. We will not permit any changes to theSPCthat requires data to be assessed.

Maintaining joint-labelling

Joint assessment of mock-ups with Ireland can only be carried out as a G.I.15.z VRA.

It is your responsibility to ensure your QRDs are harmonised in Great Britain, Northern Ireland and Ireland territories (as applicable).

Any other variation categories affecting labels will be assessed independently by the VMD. For further information on when HPRA require assessment of the labelling and package leaflet for veterinary medicinal products, see HPRAs website.

Fees

Once an application has passed validation, you will be sent an invoice for the fee by email so you must provide a valid email address in your application.

SeeApplication fees for animal medicines.

Joint Assessment timetable

The VMD andHPRAwill decide who will lead the assessment. The lead country draws up the timetable and emails it to you and the other country.

• Day 0 Assessment begins
• By day 11 The lead country sends their comments to the other country
• By day 17 The other country adds their comments and sends it back to the lead country
• By day 20 The lead country sends the consolidated list of comments to you, copied to the other country and requests revised mock-ups, if needed. These should be submitted to both countries. The clock stops and enters the company response period.
• Company Response (within 20 days) you should provide revised mock-ups to both countries indicating agreement or disagreement with the comments. The procedure restarts with the lead country issuing a new 20 day assessment timetable

If there are no comments, or the mock-ups can be approved with minor annotations, the mock-ups will be approved . In the unlikely event that we are unable to reach agreement, your application will be refused.

Contact us

Once you have applied, to discuss specific application points contact the people assigned to the application given in the validation passed email.

For all other enquiries email:postmaster@vmd.gov.uk