MAs and manufacture
For Marketing Authorisation holders and manufacturers
International collaborations
VMD is a member of PIC/S
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use.
VMD is an observer member of VICH
The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration.
| Australia | Canada | EU | Israel | New Zealand | Switzerland | US | |
|---|---|---|---|---|---|---|---|
| MRA/Annex covering veterinary GMP inspections | Yes | Yes* | Yes+ | Yes | Yes | Yes | Yes |
| Recognises veterinary GMP inspections outside territory | No | Yes | Yes^ | Yes** | No | Yes** | Yes^ |
| Includes veterinary medicines batch (QC) testing | Yes | Yes | No | Yes | Yes | Yes | Yes |
| Joint Review of applications | Yes | Yes | No | No | Yes | Yes | No |
| Links to the agreements | link | link | link | link | link | link | link |
* pharmaceuticals only. ** if the product also undergoes re-control in one of the parties. ^ may recognise inspections outside territory. + not batch (QC) control.
Simultaneous review of applications allows applicants to submit a dossier to both regulators at the same time. The evaluation is conducted independently by each country in parallel, with the objective of issuing regulatory decisions at the same time. Submissions must also meet all applicable national requirements.
This regulatory cooperation is an important step in expanding opportunities for industry to simultaneously access two major markets. It provides opportunities to reduce burdens and to have a single project team working on the submission pathway to a common assessment timeframe. It also supports our shared aim of expanding access to treatment options for animals and helping food producers stay competitive globally.
Our guidance on gov.uk outlines how the review process works.