Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Norway To Grant Pediatric Extensions Of SPCs From Sept. 1

Executive Summary

Norway has acted swiftly to amend its national legislation to allow six-month pediatric extensions to supplementary protection certificates as of Sept. 1, when the EU Paediatric and SPC Regulations will take effect in the country. Also, transitional arrangements have been put in place that will allow certificates expiring between March 1 and Aug. 31 to become valid again.

You may also be interested in...



Companies Get 19 EU Paediatric Extensions in 2016, But Many Firms Miss Trial Completion Deadlines

A report from the European Medicines Agency shows that in 2016, 19 products were awarded a six-month extension of their supplementary protection certificate for conducting pediatric trials, while the amount of scientific advice offered for pediatric medicines continued to rise.

EU Preserves Status Quo On Drugs Under Additional Monitoring

The European Commission has set aside, for now, concerns expressed by member states regarding the scope of medicines subjected to additional monitoring requirements.

Singapore And Malaysia Test Joint Evaluation

A new work sharing pilot has been launched to evaluate jointly generic drugs intended for launch in Singapore and Malaysia.

Topics

UsernamePublicRestriction

Register

PS121036

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel