[co-author: Linden Thomson]
In addition, the MHRA has updated its post-transition guidance on, among other matters: (i) importing medicines into GB, (ii) pharmacovigilance procedures (in particular on the use of country codes and worldwide case IDs when submitting Individual Case Safety Reports (ICSRs)) and (iii) its intended approach for medicinal products approved or pending in the decentralised procedure (DCP) or mutual recognition procedure (MRP).
- UK-Canada interim agreement on Good Manufacturing Practice (GMP)
On 5 January 2021, the MHRA and Veterinary Medicines Directorate (VMD) announced that they had entered into an interim agreement with the Regulatory Operations and Enforcement Branch of Health Canada. The Interim Agreement will permit ongoing mutual recognition of GMP certification and acceptance of batch testing certificates.
*We would like to thank trainees Alasdair Austin and Harriet Geddis for their contributions.