4. Initiation of a PASS


PASSs are either imposed by regulatory authorities or voluntarily initiated by MAHs.

Imposed PASSs can in the EU be requested by the EMA (the PRAC) or the respective national competent authority (NCA) during the evaluation of the initial marketing authorisation application or during the post-authorisation phase, whenever there are concerns about the risks of an authorised medicinal product for which a PASS might significantly impact the risk-benefit profile of the product. Marketing-authorisation holders (MAHs) are obliged to sponsor or conduct imposed PASSs.

A request for a PASS will be issued under the following conditions:

  • as part of the initial marketing authorisation application. A marketing authorisation may be granted under the condition that a PASS is being conducted if during the evaluation of a marketing authorisation application the need for a PASS is identified leading to a conditional marketing authorisation or under exceptional circumstances.
  • during a post- authorisation regulatory procedure. The need for a PASS could be identified by the EMA or an NCA during a post- authorisation regulatory procedure, for example, an extension or a variation to a marketing authorisation, a renewal procedure or a periodic safety update (PSUR) procedure.
  • due to an emerging safety concern. After the granting of the marketing authorisation, the EMA or NCA may impose an obligation to conduct a PASS if there are concerns about the risk of the authorised medicinal product.

Voluntary PASSs are sponsored or conducted by MAHs on their own initiative. They include non-imposed studies that are required in the risk management plan (RMP) to investigate a safety concern or to evaluate the effectiveness of risk minimisation activities (category 3 of studies in Good Pharmacovigilance Practices (GVP) Module V).

For more detailed information read here:

EMA: Post-authorisation safety studies (PASS)

Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3)