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EU Legal Regulatory Environment - Notice to the Applicants

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EU Legal Regulatory Environment - Notice to the Applicants

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Questions and Answers

What is the purpose of a marketing authorisation in the EU?

To approve the importation of generic medicinal products

To restrict the availability of herbal medicinal products

To grant permission for the marketing of a medicinal product (correct)

To regulate the manufacturing process of medicinal products

Which products are eligible for Marketing Authorisation in more than one Member State?

Known substances in new combinations only

Generic medicinal products only

Homeopathic products only

Herbal medicinal products and line extensions (correct)

What is the minimum validity period of a normal Marketing Authorisation (MA) in the EU?

Five years (correct)

Ten years

Indefinite

Three years

What is included in a marketing authorisation in the EU?

A decision granting the authorisation and a technical dossier with applicant data Signup and view all the answers

Which articles govern the submission of data for Marketing Authorisation under Directive 2001/83/EC?

Articles 8(3) to 11 Signup and view all the answers

What is the legal framework applicable to Advanced Therapy Medicinal Products (ATMPs)?

Regulation (EC) No 1394/2007 Signup and view all the answers

What does the acronym MAH stand for in relation to marketing authorisation?

Marketing Authorization Holder Signup and view all the answers

Under what circumstances can an applicant repeat the application procedure for Marketing Authorisation?

If there is no decision granting the marketing authorisation Signup and view all the answers

'Marketing Authorisation - Renewal' refers to extending the validity period of MA beyond:

$5$ years from first authorisation Signup and view all the answers