Topicals, generic [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2013-03-31 21:26 (3894 d 10:26 ago) – Posting: # 10317
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Hi ioanam,

further to what Helmut just said I can mention that inhaled and intranasal drugs also somehow are often classified as topicals.
Many inhaled topicals (:-D) are regulated by this beauty of a guideline.

In many cases you cannot call them generics (and cannot assume substition is granted like a typical generic) if they are submitted for EU approval. Check directive 2001/83 article 10.3.

Pass or fail!

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