• 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

Variations

• Variations are any change to the licensed details following approval in any Member State .

• The current variations regulation for human and veterinary medicinal products, Commission Regulation (EC) 1084/2003, came into force on 1 st October 2003 . It should be noted that the new variations regulation Commission Regulation (EC) 1234/2008 comes into force on 01 January 2010 . Currently, there are three main types of variations detailed in the regulation:

• Type IA variations – these "minor" variations generally refer to changes in the name/address of the Marketing Authorisation Holder or a change to the manufacturer's name and address, a minor change to the batch size, submission of a Certificate of Suitability for the drug substance, amongst others.

The timetable for approval of a Type IA variation is 14 days.

• Type IB variations – these "minor" variations generally refer to a change in the name of the product, minor changes to the method of manufacture for the drug substance or drug product, swapping one excipient for a comparable excipient, changes to batch size, change in shelf life of the drug product, etc.

The timetable for approval of a Type IB variation is 30 days.

• Type II variations – these "major" variations are any variations that are deemed to be outside the scope of the variations listed as Type I. For a national licence the timetable for approval is 60 days, and 90 days for a Type II variation using the Mutual Recognition Procedure.

• Ivowen Limited can prepare variations to your licence for you. We can also give you advice on what supporting data you would need for a particular variation, review the data as it becomes available and answer any questions that the Health Authority may have on your application.

• For products approved through either the MRP or the DCP all variations have to be submitted through the Mutual Recognition variation procedure, irrespective of the type of variation applied for.