Owners of Marketing Authorisations (MAs) know that rarely does a medicine and its registered details remain static. Often these activities are pre-planned, a known change to a process, an update to a Summary of Product Characteristics (SmPC) but sometimes forces of nature or other circumstances require the Marketing Authorisation holder (MAH) to take remedial action.

When this occurs the MAH needs to gather the evidence, review the change and consider the type of change or variation that needs to be made. Variations are either:

  • an administrative change such as a change of company name and/or address
  • a change to the characteristics of a product that can affect its quality, such as a change to its composition
  • a change to the safety, efficacy or pharmacovigilance of the product.

These changes are classed as major (type II) or minor. Minor changes are classed as either type 1A or 1B.

You can apply for:

  • a single change to one marketing authorisation (MA)
  • multiple changes to one or more products and/or MAs.

There are several sources for guidance for example, CMDh variation procedure Best Practice Guides (BPG), EMA, MHRA – these links can be accessed via the buttons below:

CMDh BPGs
EMA Europe
MHRA – UK

Once the data is collated and the variation type known, the documentation is created into an updated variation (eCTD sequence) and sent to the national competent agency (NCA) via the Common European Submission Portal (CESP) or, for Centrally Authorised Products, via the eSubmission Gateway or Web Client.

CESP provides a simple and secure mechanism for exchange of information between applicants and the EU regulatory agencies.

The purpose of the system is to:

  • provide a secure method of communicating with regulatory agencies via one platform
  • allow submission of an application once to reach all required agencies
  • reduce the burden for both industry and regulators of submitting/handling applications on CD-ROM and DVD.

Jenson R+ Limited can assist you with compiling the necessary data and making variations to maintain the lifecycle of your product, we can help through an end to end submission or by providing advice and guidance on the data set and process to help you keep your medicine complaint and on the market.

Contact us at consultancy@jensongroup.com.