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UK MHRA Guidance: Medicines: Reclassify Your Product
Reclassification of medicines is an important regulatory mechanism that allows changes to the legal supply status of a medicinal product in the United Kingdom. The UK guidance on reclassification explains how applicants can apply to change the classification of a medicine, outlines procedural pathways, and clarifies the regulatory expectations associated with such changes. Using the Reclassification Guidance The guidance is intended for marketing authorisation holders or app
Sharan Murugan
Mar 13 min read
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
Sharan Murugan
Mar 20, 20242 min read
Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines
Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...
Sharan Murugan
Aug 22, 20232 min read
Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form
Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...
Sharan Murugan
Jul 2, 20232 min read
UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products
The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration &...
Sharan Murugan
Oct 22, 20222 min read
UK MHRA Guidance: Medicines: How to Reclassify your Product
Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance:...
Sharan Murugan
Aug 4, 20221 min read