WorksheetsPEI Summer School Quiz - Lecture Hoppensack 01.09.21
Total questions: 8
Worksheet time: 4mins
Which legal document stipulates the requirements for the authorisation dossier of biological medicinal products?
HMA's Guidance on biological medicinal products
Annex I of the Directive 2001/83/EC
Directive 2001/82/EC
Regulation (EU) 726/2004
How many days may the initial authorisation procedure of a medicinal product maximally last?
210 days including clock-stops
210 days excluding clock-stops
not legally defned
240 days
To wich body a marketing authorisation has to be submitted if the aim is to achieve a marketing authorisatsion that is valid in the whole EU.
EDQM
CHMP
EMA
CMDh
Who issues the authorisation in Centralised Procedures?
CHMP
European Council
European Commission
PEI
Under which circumstances can an applicant use the Decentralised Procedure?
always
When he has already obtained a MA in the EU for this medicinal product.
Only when a MA in the United States have already been obtained.
When use of the Centralised Procedure is not mandatory and no MA has yet been obtained in teh EU.
How many medicinal products can be affected by a referral procedure
More than 100 medicinal products
The number of medicinal products affected depends on who triggers the referral
The number of medicinal products may vary and is specific for each procedure.
1 - 100 medicinal products
Which of the following statements on Renewals is correct?
The application is due 3 years after initial authorisation
Only new clinical data is assessed during renewals
For medicinal products with know active substances no renewal is required.
The renewal application is due at least 9 months before the MA expires.
Grouping of Variations and Variation Worksharings serve to?
Reduce variation fees
Reduce the workload for applicants only
Significantly reduce the assessment timelines
Reduce the workload for applicants and compentent authorities
