9. Are there any special requirements of OGYÉI concerning the version control of risk minimisation tools or programs?

According to GVP Module XVI Addendum I, risk minimisation materials should be marked with a version number and the date of approval. OGYÉI is convinced that version control contributes to an easy identification and tracking of the latest, effective version of the risk minimisation material, as these can be updated several times during a medicine’s lifecycle (they can even be merged or split into parts). It is important that healthcare professionals, patients, and OGYÉI can easily track which version of the risk minimisation tool is effective, which was disseminated the last time. In order to accomplish this goal, OGYÉI introduces a uniform version control for all risk minimisation tools or programs disseminated in Hungary.

The MAH may have its own version control or numbering beside the Hungarian version control system; nevertheless, the Hungarian version control should be dominant on the material.

For distinguishing among various versions of risk minimisation materials, version numbers and approval dates (or dates of acknowledgment) are used. These should be indicated on the final, approved materials. The version number is a positive integer and a decimal value (e.g. 12.0), starting from 1.0. During updates, if key elements are amended, or there are significant changes introduced (e.g. new indication approved), the version number increases to the next integer (e.g. from 1.0 to 2.0). In case of an administrative update, the decimal value increases (e.g. from 2.0 to 2.1).

The approval date is sent to the MAH by OGYÉI following the assessment of the final mock-up (within 3 business days in case of compliance with proposed corrections), thus, the material should be completed with the correct date after approval. Version number and approval date (year/month or year/month/day) should be indicated on every page of the risk minimisation material, if possible, according to provisions of GVP. (E.g. version 12.1, date of OGYÉI approval: March 1, 2017)

There might be risk minimisation programs where various items belonging to the same program will possess different version numbers and approval dates. This is normal, as updates may not always include all items of a risk minimisation program (e.g. a physician brochure is updated but a checklist is not).

Updates to already approved risk minimisation materials should also be subject to version control detailed above. In this case, it is up to the MAH to assign a version number to the next upcoming update, i.e. it may start with version 1.0 or a higher version number in line with a version number of a previous material. However, it is important to observe the above rules. Subsequently, version updates should proceed as detailed above.