Series change

A series change can be applied for when the same change is to be made to more than one product. Generally a company can apply for a series change if the desired change falls into one of the following categories:

• There is a single approval holder which is changed for another
• There is a single marketing company that is changed for another
• both of the above occur

Companies, however, should contact HSE prior to applying to discuss the details of the desired changes. Once a course of action has been agreed the procedure for applying is as follows:

• Companies should submit a letter to HSE, detailing the desired changes along with any necessary letters of authorisation or declaration.
• A fee is then invoiced to the applicant.
• Once the fee is received, the change can commence. At this stage, any outstanding information, for example packaging details will be requested.
• In the case of a merger between two companies, a statement on letter headed paper from each company stating the details of the merger and the name of the new company. On occasion, confirmation letters from solicitors are requested.

Once this information is received, the approval holder will receive a Notice of Amendment detailing the changes made.