The phrase "authorisation list" is correct and usable in written English.
It can be used in contexts where a list of individuals or entities that have been granted permission or approval for a specific action is needed.
Example: "Please refer to the authorisation list to ensure that only approved personnel have access to the secure area."
Alternatives: "approval list" or "permission list".
The "Note for guidance on the inclusion of appendices to clinical study reports in marketing authorisation applications" lists the appendices required to be submitted to the EMA with each CSR.
As part of the "Sponsor's submission of evidence", manufacturers/marketing authorisation holders should list all clinical and follow-up studies sponsored by them or known to them, unpublished clinical data (raw data), part-published data (e.g. in abstract form), confidential data, and any evidence from disease registers (Section 3.3.2 to 3.3.8, 3.3.12, and 4.2.1 GMTA).
The inclusion of substances in the candidate list for authorisation by identification as a substance of very high concern (SVHC) has made good progress.
Substances of very high concern (SVHC) (e.g. PBT/vPvB) are included in the 'candidate list' for authorisation, based on the outcome of the scientific assessment of intrinsic properties.
SVHC by definition of the REACH regulation are those substances that are included in the candidate list for authorisation on the basis of their classification as CMR, their PBT or vPvB properties or of their equivalent level of concern (ELC) [27].
The decision came less than a week after the government gave final authorisation for the partial listing.
The technical regulation restricts international trade by imposing an authorisation requirement for SVHC listed in Annex XIV REACH and that are used in imported articles.
EMA: European Medicines Agency; EPAR: European Public Assessment Report; G-BA: Federal Joint Committee PAMM: post-authorisation measure Table 1 List of products with conditional appraisalsa and/or PAMsb Product Brand name Indication Conditional appraisalsd PAMse y/n Time frame (years) Number Time frame (years) Aclidinium bromide Eklira Genuair/Bretaris Genuair COPD No - 1 n.a.a
Moreover, the candidate list and the authorisation procedure stir great uncertainty among companies that use the listed substances in industrial processes and syntheses.
The impression arises that the candidate list and the authorisation procedure are increasingly being politically exploited.
