1. Management of product authorisations for in situ generated AS
CA-Sept-doc th September - Brussels

2. Overview Why a completely new draft? Objective of the regulatory note
Content of the regulatory note
Next steps

3. Why a complete new draft?
Bilateral discussions SANTE - ECHA
Feedback from MSs
Considering:
The complexity of the matter
Technical details should be addressed by experts from ECHA and CAs
SANTE and ECHA agreed that:
SANTE introduces a regulatory document addressing the key principles for product autorisation of IGSs
ECHA will prepare technical guidance which will describe which data will be required to support an application for IGS authorisation

4. Objective of the regulatory document
Describes a pragmatic approach for product autorisation of IGS based on 5 principles:
Cover a wide diversity of IGS
Benefit from the BPF concept
Optimise the approval and the autorisation stages
Provide complementary guidance on data requirements. Existing technical standards for precursors and devices should be considered
Avoid disrupting effects on the market

5. Content of the regulatory document
Data requirements
Additional data not provided at the approval stage and that are specific to IGS shall be submitted
Access to Annex II data relevant for precursors, the generation process and the generated AS (LoA) should be optimised as much as possible
Assessment of the application
Consider relevant IGS parameters (reference to standards, device settings)
Ensure that the IGS (compliant with the relevant parameters) is safe and efficient
Authorisation: SPC includes
Reference to relevant standards
Information about relevant device parameters
3 models of SPC to be developed for the 3 identified case types

6. Next steps
Comments on CA- Sept18- Doc 4.7 are welcome before
The "regulatory" note will be revised accordingly and will be presented for agreement at the November CA meeting.
ECHA will inform at the November CA meeting about:
Which technical guidance would be needed compared to what is already available in the recommendations of the BPC WGs
Under which instrument/format to provide such a guidance (new document vs. amending the current WG recommendations)
Timelines to have that guidance available