• eCTD
• Abridged Applications
• National Procedures
• Mutual Recognition Procedure
• Decentralised Procedure
• Centralised 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

Centralised Procedure

• Abridged applications for human medicinal products in the EU are applications made under Article 10(1) of Directive 2001/83/EC, as amended.
• Abridged applications for veterinary medicinal products in the EU are applications made under Article 13(1) of Directive 2001/82/EC, as amended.
• The Centralised Procedure (CP) is available to use for generic applications The CP gives the Marketing Authorisation Holder (MAH) a Community Authorisation which allows the MAH to market in all MSs of the EU and EEA on one licence/MA.
• The CP is fully electronic and Ivowen Limited has full eCTD capability.
• Ivowen Limited has a wealth of experience in preparing and submitting dossiers using the CP system, for both human and veterinary medicinal products.
• Ivowen Limited can manage all htmlects of the procedure independently or in liaison with your own Regulatory Affairs department.

Contact us for more information.