"authorisation holder" is correct and usable in written English.
You can use it when referring to an individual or organization with legal permission to do or have something, such as permission to work in a certain country or to use a particular piece of property. For example, "The authorisation holder is responsible for ensuring the safety of all construction operations."
If there is no agreement struck that the EMA will remain the "marketing authorisation holder" for the UK, then there will be a fracture.
Other official monitoring costs that are not fully passed on to the PPP authorisation holder or PPP users in the form of fees and are instead tax-funded (e.g., the portion of costs for official authorisation procedures that are not refinanced, consultancy, and monitoring costs of the plant protection services of the Federal States, costs of PPP-specific research by public research institutions).
Access to the data, however, depended on the goodwill of Merck Darmstadt, the marketing authorisation holder.
Eli Lilly is the marketing authorisation holder and manufacturer of atomoxetine in the UK and has financed this manuscript.
Another determinant of the overall cost of a medicine is the information service offered by the marketing authorisation holder.
The decision to remove a drug product from the market is not taken lightly either by the regulatory authority or the marketing authorisation holder.
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authorisation holders should list all clinical and follow-up studies sponsored by them or known to them, unpublished clinical data (raw data), part-published data (e.g. in abstract form), confidential data, and any evidence from disease registers (Section 3.3.2 to 3.3.8,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).
Marketing authorisation holders of recalled medicines were either licensed manufacturers or distributors.
It is the responsibility of the manufacturers and marketing authorisation holders to recall their substandard products after consultation with Health Canada.
The majority of these recalls were issued by the manufacturers or marketing authorisation holders using the Health Product Recall type I, II and III, which accounted for 95% of the total substandard medicines reported.
Second, the reason given for not posting the clinical data is revealing: sponsors who are not marketing authorisation holders in the USA are not obligated by US public law 110-85.
