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Life Cycle Management of Medicinal Products

Life Cycle Management

As soon as the marketing authorisation has finally been granted, it seems that the last regulatory notes have faded away and the licensing orchestra takes a break – but then a new kind of music will begin: the jingling of coins when the money is rolling in…

To prevent this jingling sound from fading away, each marketing authorisation has to be kept up-to-date from a scientific and technical point of view. A short and simple sentence – but highly explosive if not constantly kept in mind.

Notifiable variations may result from developments in the regulatory environment (e.g. guidelines) of the medicinal product. Product changes may also become necessary due to changes in the corporate policy of the marketing authorisation holder. Another source of continuous changes is the progress in pharmacological and medical research, in particular in the field of side effects.

Here are some examples of emerging variations (notifications of change):

A new or updated relevant guideline requires additional data or a risk assessment. The API manufacturer(s) has/have updated his CEP or ASMF. Hence the marketing authorisation has to be updated accordingly.

Due to a merger or acquisition, the marketing authorisation holder and/or pharmaceutical manufacturer responsible for release of the product has changed, and the medical information texts (labelling, patient information leaflet, summary of product characteristics) have to be adapted accordingly. That sounds simple but the logistic coordination between Production, Quality Control and Regulatory Affairs can be a Herculean task to ensure and maintain the marketability of the product(s) concerned.

The originator drug monitoring reveals new side effects or changes to the frequency of adverse drug events, and the patient information leaflet (PIL) and summary of product characteristics (SPC) have to be adapted accordingly. Such adaptations may also result from concluded or published PSUSA-PSUR procedures. Speaking of PSUSA-PSURs: If such a procedure is foreseen on the List of European Union Reference Dates (EURD list) for an active ingredient, PSURs must be written and submitted in due time.

This will lead us to the pharmacovigilance topic which holds some more duties for the marketing authorisation holder: keep product information in xEVMPD up to date, monitor side effects and submit them as ICSRs, detect signals – this list is far from being complete…

And last but not least: Each new marketing authorisation is only granted for a limited period of 5 years, and a renewal application has to be filed not later than 9 months before the end of this period. If you fail to meet this deadline, the money will soon stop rolling in…

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