e-Learning: Introduction to EU Marketing Authorisation

Program Module 1: Overview of the law and EU regulatory network

European Union law

National law

Soft law

EU regulatory network

After having passed this module you can destinguish in between binding law and soft law and understand the principles of the European regulatory network.

Module 2: Principles

Why marketing authorisations?

The European Economic Area (EEA)

What is a medicinal product?

Scope of Directive 2001/83/EC

After having passed this module you understand the scope of Directive 2001/83/EC. You know under which conditions a product needs a marketing authorisation.

Module 3: Procedures

National ("one-member-state") procedure

Mutual recognition procedure (MRP)

Decentralised procedure (DCP)

Referrals

Centralised procedure (CP)

Conditions

After having passed this module you understand the marketing authorisation pathways in the EU and know which product is eligable to which procedure.

Module 4: Application types

Dossier

Legal basis

Generics

Data exclusivity

Homeopathic and herbal medicinal products

After having passed this module you understand the legal basis for each group of drugs and know which data has to be submitted to the authorities when applying for a marketing authorisation.

Module 5: Post authorisation

Renewals

Sunset clause

Variations

After having passed this module you know your duties in the drug lifecyle management and understand the variations system.


Program Module 1: Overview of the law and EU regulatory network

European Union law

National law

Soft law

EU regulatory network

After having passed this module you can destinguish in between binding law and soft law and understand the principles of the European regulatory network.

Module 2: Principles

Why marketing authorisations?

The European Economic Area (EEA)

What is a medicinal product?

Scope of Directive 2001/83/EC

After having passed this module you understand the scope of Directive 2001/83/EC. You know under which conditions a product needs a marketing authorisation.

Module 3: Procedures

National ("one-member-state") procedure

Mutual recognition procedure (MRP)

Decentralised procedure (DCP)

Referrals

Centralised procedure (CP)

Conditions

After having passed this module you understand the marketing authorisation pathways in the EU and know which product is eligable to which procedure.

Module 4: Application types

Dossier

Legal basis

Generics

Data exclusivity

Homeopathic and herbal medicinal products

After having passed this module you understand the legal basis for each group of drugs and know which data has to be submitted to the authorities when applying for a marketing authorisation.

Module 5: Post authorisation

Renewals

Sunset clause

Variations

After having passed this module you know your duties in the drug lifecyle management and understand the variations system.


Program
Program


Module 1: Overview of the law and EU regulatory network

European Union law

National law

Soft law

EU regulatory network

After having passed this module you can destinguish in between binding law and soft law and understand the principles of the European regulatory network.

Module 2: Principles

Why marketing authorisations?

The European Economic Area (EEA)

What is a medicinal product?

Scope of Directive 2001/83/EC

After having passed this module you understand the scope of Directive 2001/83/EC. You know under which conditions a product needs a marketing authorisation.

Module 3: Procedures

National ("one-member-state") procedure

Mutual recognition procedure (MRP)

Decentralised procedure (DCP)

Referrals

Centralised procedure (CP)

Conditions

After having passed this module you understand the marketing authorisation pathways in the EU and know which product is eligable to which procedure.

Module 4: Application types

Dossier

Legal basis

Generics

Data exclusivity

Homeopathic and herbal medicinal products

After having passed this module you understand the legal basis for each group of drugs and know which data has to be submitted to the authorities when applying for a marketing authorisation.

Module 5: Post authorisation

Renewals

Sunset clause

Variations

After having passed this module you know your duties in the drug lifecyle management and understand the variations system.


Module 1: Overview of the law and EU regulatory network ...