Streamlined EU Supplementary Protection Certificate System Moves Ahead

A parliamentary committee says the proposals will remove the fragmentation in the EU SPC system and bring predictability for both the innovative and generics industry.  

Patent
SPCs extend the effective life of a pharmaceutical patent • Source: Shutterstock

A more harmonized, predictable and less costly EU-wide system for obtaining supplementary protection certificates (SPCs) for medicines has moved a step closer after the European Parliament’s legal affairs committee (JURI) unanimously backed two draft EU regulations that will now be voted on by the full parliament.

One of the regulations would allow applicants to obtain an SPC in designated EU member states by filing a centralized SPC application that would undergo a single examination procedure, rather than having to apply in each member state separately

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

More from Geography

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.