TBT BSN | Notification

Notification Detail :: G/TBT/N/GBR/86

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

The Human Medicines (Amendments Relating to the Windsor Framework) Regulations 2024

Objective

Consumer information, labelling (TBT)

Product Covered

Human Medicinal Products

Document Notification

Link to ePing

HSCODE

ICSCODE

11.120 - Pharmaceutics

Keywords

Human health

Specific Regions

Description

The Regulations provide that a “UK marketing authorisation” comprises the following different types of authorisation: UKMA(UK)(Category 1) and UKMA(Category 2), which permit marketing of a medicinal product in all the territories of the UK; UKMA(GB) which does not permit marketing of a medicinal product in Northern Ireland; and UKMA(NI) which does not permit marketing of a medicinal product in Great Britain. These Regulations make amendments to the 2012 Regulations ensure that the correct type of authorisation is referred to. The Regulations make provision to transition existing marketing authorisations with an authorisation with a territorial limit of Great Britain to be converted to authorisations valid across the UK.The Regulations also make provision for a new requirement, for each of the above categories of authorisation, for products to be labelled “UK only”; and provision to disapply the product identification and anti-tampering device rules contained in Commission Delegated Regulation (EU) 2016/161.The changes made by the Regulations mean that the same products, in the same packs with the same labels, will be available across the whole of the UK

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/GBR/86

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