• 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

National Procedures

• Abridged applications for human medicinal products in the EU are applications made under Article 10(1) of Directive 2001/83/EC, as amended.

• A national application is made when your company wishes only to market in one country in the EU. Therefore, no Mutual Recognition Procedure or Decentralised Procedu re is planned.

• Ivowen Limited is well versed in the preparation and submission of applications for national marketing authorisations, or licences, in all EEA states. We would act as liaison to the Health Authority on your behalf to answer any queries arising from the application.

• Ivowen Limited would also liaise with the Health Authority on your behalf before the application is submitted should there be any need to seek the Health Authority's advice prior to submission. (See Regulatory Strategy ).

• Ivowen Limited has full eCTD capability.