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Does the strength and pharmaceutical form need to be added to the Registered Product Name to form the Name of the Medicinal Product?
Does the strength and pharmaceutical form need to be added to the Registered Product Name to form the Name of the Medicinal Product?

Strength and pharmaceutical form fields on the EU HUB

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Written by Lorenzo Mari
Updated over a week ago

According to our investigations, the name should be followed by the strength and form information as indicated in the guidance document by reference to SmPC rev.
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Ultimately however, this is only guidance – you should seek detailed clarification from the regulator responsible for the market(s) on which your product is sold, as EMVO is not a regulatory authority, and this data is not used within the EMVS (currently) for any other purpose than report content/decoration.
The majority of the master data elements were imposed on the system by the Delegated Regulation (Art. 33(2)), and EMVO does not have the history to know why the master data in that article is so rich in content. Your regulatory authorities should be able to provide the background and guidance.
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The EMVS Master Data Guide is available in our Documents Overview.

For further clarification on this article please feel free to contact the EMVO helpdesk.

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