Combining a medicinal product with disinfectant/cleaning wipes

It is possible to package medicinal products and disinfectant/cleaning wipes together. There are no specific requirements for this, but in general this applies to individually packed wipe sachets with a batch number and expiry date. If a previously authorised medicinal product is to be packaged with disinfectant/cleaning wipes, a variation application of Type IB “B.z. Other quality variation” is to be submitted with the following documents: (1) Specifications for the proposed disinfectant/cleaning wipes (2) Corrected medicinal product information: cleaning wipes to be listed in the Information for Professionals under section 6.5 “Type and nature of container” (or under section 15 “Other information” of the Patient Information Leaflet) and not under Composition. (3) Corrected packaging elements: additional comment “disinfectant/cleaning wipes” to be added.