• eCTD
• Abridged Applications
• National Procedures
• Mutual Recognition
• Decentralised Procedure
• Variations
• Renewals
• Paediatric Investigation Plans (PIPs) and
  Paediatric Use Marketing Authorisations(PUMAs)
• Certificates of Suitability
• Biostudy Management
• Regulatory Strategy
• Pharmacovigilance
• Compliance
• Herbal Medicinal Products
• Training
• Veterinary Medicinal Products
• Project Management

Renewals

• Marketing authorisations/licences for human and veterinary medicinal products will have unlimited validity. However, the marketing authorisation must be renewed at least once within five years of approval and must be placed on the market within three years of approval.

• A further renewal may be necessary on pharmacovigilance grounds.

• As part of the renewal procedure, a Periodic Safety Update Report (PSUR) must be submitted. This provides the Health Authority with information on any adverse events to the product over that period. (See Pharmacovigilance ).

• Ivowen Limited can prepare renewal applications and accompanying PSURs on request.

• Ivowen Limited can also review your data in preparation for a renewal application.