The following changes will be made in connection with the TPA/TPO revision process:
The addition of the Risk Management Plan as per Art 4 TPO will involve the use of an instrument designed to record not only the known risks, but also the identified potential risks even at the authorisation stage.
Moreover, as a result of the revision of Article 59, para. 3 TPA, professionals who are authorised to administer or dispense medicinal products but who do not usually do so – for example forensic pathologists – will now be subject to mandatory reporting.
The term "safety signal", which is now established internationally, will be adopted. The previous wording was ambiguous.
Another, albeit minimal, change to the TPO is designed to ensure that the Agency is informed sooner about international safety signals, particularly about corresponding procedures of authorities in other countries, and demand corresponding risk-reducing measures (per Art. 16 TPO).
Findings from market surveillance that are relevant to therapeutic product safety will now be published (Art 7a TPO: Informing the public).