Module 1 2021

30/06/2021

Name of the product Strategic Choice

 Name of the Medicinal Product (art 1(20+21) Dir 2001/83/EC) ● Either an invented name not liable to confusion with the common name ● Or a common name or scientific name accompanied by a trademark or the name of the marketing Authorisation Holder; ● Common name; International non-proprietary name (INN) recommended by the WHO;  Centralised Procedure ● 1 Name in the EU; ● Multiple/Duplicate Applications Possible;  MRP/DCP ● Different Names in different EU Countries ● Name Flexibility ● Multiple/Duplicate Applications Possible

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 Centralised Procedure ● Variations submitted as one package to EMA; ● Single List of Questions received from EMA;  MRP/DCP ● Package submitted to RMS and all CMS; ● Questions raised by RMS and CMS;  Post Approval Commitments - Conditional Approval or others  Annual reassessment – Exceptional circumstances Post- Marketing Considerations

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