The centralised procedure is mandatory for marketing authorisation applications (MAAs) of new active substances for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, all biologicals, advanced therapies, and orphan products.
As a result of the 3-year experience with the "bottleneck control" system at Frankfurt/Main Airport, the Hesse Ministry of Energy, Environment, Agriculture and Consumer Protection has voiced its opinion in the authorisation directive that mandatory prior notification is essential for all non-animal food products imported into the European Union.
As a result of the 3-year experience with the "bottleneck control" system at the Frankfurt Airport, the Hesse Ministry of Energy, Environment, Agriculture and Consumer Protection has voiced its opinion in the authorisation directive that mandatory prior notification is essential for all non-animal food products imported into the EU.
These dominate mandatory spending, which does not require annual authorisation.
In Andalusia, a law provides mandatory and binding health impact reports for most authorisation procedures in different areas: from sectoral plans to urban planning schemes, and especially projects subject to environmental assessment.
(The other part of the budget, mandatory programmes, or entitlements, do not require annual spending authorisation, remaining in force unless they are modified).
The grace period was necessary because the marketing authorisation for NRT stipulates that it is mandatory to first ask people to stop smoking without NRT; NRT should only be prescribed to pregnant smokers if they are unable to quit.
Posting of clinical data is not mandatory for trials sponsored by companies who are not the Marketing Authorisation Holder in the USA.
Distributors should therefore obtain an authorisation from the relevant rightholders as concerns their respective participation in such acts, subject to mandatory collective management.
Next step: abolish authorisation".
