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Change of Ownership

Change of Ownership

A Change of Ownership Application (COA) is the regulatory process by which an MA can be transferred from one Marketing

Authorisation holder (MAH) to another. Most commonly this occurs when a company acquires an MA or is merged with or acquired by another company.

The process by which an MAH may transfer ownership of an MA varies greatly from country to country. In some cases, a simple notification by letter is sufficient; in others a new MA must be sought.

Aside from the regulatory tasks, logistically a Change of Ownership needs carefully planning to ensure timely liaison with all necessary functions within the organisation ensuring the smooth transition from one livery to another ultimately maintaining continuity of supply to the market.

CambReg can:

  • Identify submission requirements for countries concerned
  • Define the optimum strategic approach
  • Co-ordinate activities with the necessary departments
  • Plan the entire project – taking account of any potential rate limiting steps such as:
    • Ongoing regulatory submissions / obligations
    • Who needs to submit the application
    • Product Information changes
    • Grace period of introduction of new livery/packaging
    • Assessment times within the Heath Authority
    • Country specific issues (e.g. Pricing and Reimbursement)
    • Prepare and submit the COA applications


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