CRED NPM

05/11/2024

MA procedure

Centralised

MRP / DCP

National

Guarantees complete harmonisation all over the EU

The main path to market nowadays as allows to choose Member States

Procedure of choice in the past)

Not a success so far

Alli (orlistat) 2009 Pantoprazole 2009 Nexium (esomeprazole) 2013 ellaOne(ulipristal) 2015 Fortacin(prilocaine+ lidocaine) 2020 Desloratadine 2020

The Organisation for Professionals in Regulatory Affairs

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Centralised procedure

DCP/MRP

Advantages

Disadvantages

Advantages

Disadvantages

Harmonisation

One dossier, one approval and one product information (PI)

Possibility to choose countries in the procedure

Mixed legal status procedure often the case and multiple procedures may be needed – can be 2 or 3 in parallel • Some countries may never gain OTC status. • Mixed legal status issues

Legal Status

• Included in the dossier and thus part of the evaluation • Opportunity to get OTC in all countries

Risk of OTC in none, even those that are favourable.

• Decided by NCA; CMS may change view on legal status during procedure • Can choose favourable MS for OTC

Future Rx to OTC Switch

As above, all countries Hard to get majority vote

Possible to select MS As above

Name

Harmonised

For non-unified market, difficult to capitalise on existing brands (eg pantroprazole which submitted 5 dossiers)

Flexibility

Discussions on naming may delay national phase

Maintenance

Easier

The Organisation for Professionals in Regulatory Affairs More complex

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