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Sharan Murugan
Feb 13 min read
UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has issued several guidance documents detailing the licensing,...
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Sharan Murugan
May 1, 20242 min read
Swissmedic Guidance: Import of a Human Medicinal Product (Parallel Import)
Today (01 May 2024) Switzerland's Swissmedic released updated guidance on "Import of a Human Medicinal Product according to Art. 14 para....
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Sharan Murugan
Jan 16, 20241 min read
South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation
Earlier today (16 January, 2024) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline For...
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Sharan Murugan
Jul 15, 20232 min read
Ireland HPRA: Guidance on Parallel Imports of Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Parallel Imports of Human Medicines" last week (12...
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Sharan Murugan
Jul 12, 20231 min read
Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...
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Sharan Murugan
May 21, 20231 min read
Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)
Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and...
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Sharan Murugan
Jan 8, 20231 min read
Australia TGA: FAQ Importing & Supplying Medical Devices
Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions...
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Sharan Murugan
Oct 22, 20222 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 &...
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Sharan Murugan
May 26, 20221 min read
USFDA- Q&A Guide on Importation of Prescription Drugs from Canada
Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...
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Sharan Murugan
Mar 30, 20221 min read
Guidance on Requirements for Import / Re-export Medical Imaging Materials - SFDA
On 27 March,2022 the Saudi Food and Drug Authority (SFDA) released this guidance detailing the Requirements for the Import and Clearance...
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Sharan Murugan
Mar 6, 20222 min read
USFDA: 3 updated Guidance on PLAIR, VQIP & Recalls
As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which...
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Sharan Murugan
Dec 7, 20212 min read
Parallel Imports of Human Medicines– Ireland HPRA
Parallel importation “The importation from an EU Member State, or an EEA country, of a medicinal product which is equivalent to one...
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