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17 Total results for product and free and sample content found

Pink Sheet

Brexit: New Rules Will Hit Parallel Trade From UK to EU

Brexit: New Rules Will Hit Parallel Trade From UK to EU

From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries. 

Topic EU Pharma-Brexit Brexit

Pink Sheet

Brexit Issues Lead NICE To Delay Methods Review

Brexit Issues Lead NICE To Delay Methods Review

England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”

Topic Brexit Pharma-Brexit EU

Pink Sheet

Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals

Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals

Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.

Topic Pharma-Brexit Brexit

Pink Sheet

UK Firms Face Thousands Of Variations To Update Safety Information

UK Firms Face Thousands Of Variations To Update Safety Information

With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.

Topic Pharma-Brexit Safety Brexit

Pink Sheet

Act Quickly On Converted EU Product Approvals GB Firms Urged

Act Quickly On Converted EU Product Approvals, GB Firms Urged

The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year. 

Topic Pharma-Brexit Brexit Approvals

Pink Sheet

How To Get Orphan Drug Status In Great Britain From 2021

Pink Sheet Brexit Orphan Drug Status

Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period

Topic Pharma-Brexit Rare Diseases

Pink Sheet

UK Explains Approach To Renewing Converted EU Drug Approvals in 2021

UK Explains Approach To Renewing Converted EU Drug Approvals in 2021

The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.

Topic EU Pharma-Brexit Brexit

Pink Sheet

Gloom Over Prospects For Brexit Trade Deal

Gloom Over Prospects For Brexit Trade Deal

With time running out on the UK-EU trade deal negotiations, the UK life sciences industry looks at the fine print of the new guidance on medicines regulation and explains why a mutual recognition agreement is urgently needed. 

Topic Pharma-Brexit Regulation Brexit

Pink Sheet

UK Offers Pragmatic Approach To Safety Reporting From Jan 2021

UK Offers Pragmatic Approach To Safety Reporting From Jan 2021

The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.

Topic Pharma-Brexit Brexit

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