The UK Medicines and Healthcare products Regulatory Agency is introducing a new monitoring system for packaging from February 2026. The aim is to streamline regulatory control while ensuring compliance with existing standards.
The UK Veterinary Medicines Directorate (VMD) is introducing a new system for monitoring the packaging of veterinary medicinal products on 2 February 2026. With the so-called packaging monitoring programme, the authority is adapting its existing inspection and control mechanisms to ensure proportionate supervision and at the same time reduce the administrative burden on the animal health industry. In future, compliance with regulatory requirements will increasingly be checked on the basis of products that are already available on the market.
Regular market review instead of purely formal prior checking
As part of the new system, the VMD selects a range of veterinary medicinal products on a quarterly basis and checks their packaging. The products are purchased from wholesalers and all packaging components are then checked. This involves checking whether the information corresponds to the approved product information texts in accordance with the specifications of the quality review templates (QRD texts) and complies with the principles of the standards for product information.
The results of the respective review round are communicated to the responsible authorisation holders within the three-month review period. If the authority identifies deviations, the necessary corrective measures are specified. Depending on the severity, this can range from an adjustment at the next regulatory opportunity to the submission of a formal notification of change or even classification as a product defect. The deadlines for implementation depend on the respective assessment.
Changed requirements for design reviews of packaging
Parallel to the introduction of the new monitoring system, the VMD is adapting its requirements for the submission of packaging designs. From 2 February 2026, it will not be mandatory to submit designs for change notifications with a G.I.18 review requirement or as part of new authorisation procedures. The authority intends to continue to review designs when they are submitted for the first time prior to market launch, in the case of joint assessments with the Irish Medicines Agency following the granting of a new marketing authorisation or in the case of significant changes to the design or layout that are not evident from the summary of product characteristics.
If a design review is required, the submission of the smallest pack size on the market will be sufficient in future. Routine reviews are not planned for other change categories, but can be requested on a case-by-case basis if legibility or design could be significantly affected, according to the statement.
Transitional arrangements for ongoing proceedings
A transitional arrangement applies to ongoing variation procedures in category G.I.18 and new applications for authorisation that have not yet been completed by the deadline of 2 February 2026. Draft packaging that has already been requested or submitted will continue to be reviewed. Applications that have not yet reached this procedural step are to be finalised without a design requirement in future.
Source: VMD
