2. European Pharmacopoeia monograph

The European Pharmacopoeia describes the various galenic forms in a general monograph entitled "Ophthalmic preparations". It includes general paragraphs on the definition, production, sterility testing, storage and labeling of eye drops. It then goes on to detail the different categories of ophthalmic preparations, with specific elements for each one, which may relate to definition, testing, production or labeling.

The various categories and their definitions are as follows:

• eye drops :

  "Sterile aqueous or oily solutions, emulsions or suspensions containing one or more active substances and intended for ocular instillation.

• ophthalmic lavage solutions :

  "Sterile aqueous solutions for rinsing or washing the eyes, or for soaking eye...