How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?
The legal basis for granting a marketing authorisation in Germany is section 21(1) of the Medicinal Products Act (AMG); the content requirements for the marketing authorisation documentation are laid down in sections 22 to 24 AMG.
The time frame for a marketing authorisation is approximately seven months, with a cost of around €50,000.
Once an authorisation is granted, it is initially valid for five years, and in special cases, for only one year. After five years, there must be examination of whether the medical benefit of the medicinal product is still greater than its potential risks (eg, owing to side effects). Basically, once a renewal request has been approved, the marketing authorisation is valid for an unlimited period.
Under the ‘sunset clause rule’, approvals may expire under certain circumstances. The sunset clause rule applies if a pharmaceutical entrepreneur does not make use of the marketing authorisation for a period of three years (ie, does not place the drug on the market). Placing on the market is understood as the manufacture, supply or storage for the purpose of supply.
Protecting research data
What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add…