9 Questions
What is the purpose of a marketing authorisation in the EU?
To grant permission for the marketing of a medicinal product
Which products are eligible for Marketing Authorisation in more than one Member State?
Herbal medicinal products and line extensions
What is the minimum validity period of a normal Marketing Authorisation (MA) in the EU?
Five years
What is included in a marketing authorisation in the EU?
A decision granting the authorisation and a technical dossier with applicant data
Which articles govern the submission of data for Marketing Authorisation under Directive 2001/83/EC?
Articles 8(3) to 11
What is the legal framework applicable to Advanced Therapy Medicinal Products (ATMPs)?
Regulation (EC) No 1394/2007
What does the acronym MAH stand for in relation to marketing authorisation?
Marketing Authorization Holder
Under what circumstances can an applicant repeat the application procedure for Marketing Authorisation?
If there is no decision granting the marketing authorisation
'Marketing Authorisation - Renewal' refers to extending the validity period of MA beyond:
$5$ years from first authorisation
Explore the Notice to Applicants for general regulatory guidance on the interpretation and implementation of new pharmaceutical legislation within the European Union. Find updated guidance published by the European Commission on Eudralex v.2 NtA.
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