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MHRA Guidance: Registering to Manufacture, Import, or Distribute Active Substances
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has established guidelines " Medicines: Register to manufacture, import...
Sharan Murugan
Mar 262 min read
26 views
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Australia (TGA) Med Dev User Guide: Completing an Application for Consent to Import, Supply, or Export a Medical Device That Does Not Meet the Essential Principles
The Therapeutic Goods Administration (TGA)Â has released Version 3.0Â of its user guide, effective from March 2025, " Completing an...
Sharan Murugan
Mar 222 min read
15 views
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Malaysia MDA Med Dev Guidance: Importation of Medical Devices for Re-Export (IRE)
The Medical Device Authority (MDA) of Malaysia, under the Ministry of Health, has introduced a guidance " Importation of Medical Devices...
Sharan Murugan
Mar 182 min read
7 views
0 comments
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,...
Sharan Murugan
Feb 13 min read
40 views
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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....
Sharan Murugan
May 1, 20242 min read
18 views
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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...
Sharan Murugan
Jan 16, 20241 min read
17 views
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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...
Sharan Murugan
Jul 15, 20232 min read
33 views
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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...
Sharan Murugan
Jul 12, 20231 min read
131 views
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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...
Sharan Murugan
May 21, 20231 min read
177 views
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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...
Sharan Murugan
Jan 8, 20231 min read
103 views
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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
29 views
0 comments
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...
Sharan Murugan
May 26, 20221 min read
5 views
0 comments
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...
Sharan Murugan
Mar 30, 20221 min read
21 views
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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...
Sharan Murugan
Mar 6, 20222 min read
10 views
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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...
Sharan Murugan
Dec 7, 20212 min read
29 views
0 comments