Specifying the instructions for products with a combination of professional and non-professional use
In the Legal Conditions for Use and Directions for Use (WG/GA) of a product, it is possible to specify the user category: professional and non-professional. This is stated in Part A of the (WG/GA). Three users categories are possible: "professional," "non-professional," and "professional and non-professional".
The word "exclusively" is used to designate the authorised user category, which can cause problems if a product has separate WG/GAs for professional use and non-professional use. To prevent products from being placed on the market with conflicting instructions, it is now possible to remove the word "exclusively" from Part A of the WG/GA. There are three options:
- The product is intended exclusively for non-professional use OR for professional use.
Option 1 should be chosen if the product is only for non-professional use OR professional use. The user category from the phrase that is not relevant to the application should be removed.
- The product is intended exclusively for non-professional use AND for professional use.
Option 2 should be chosen if the product is for both non-professional and professional use and the WG/GA Part A and Part B are identical for both use categories.
- The product is intended for non-professional use.
The product is intended for professional use.
Option 3 should be chosen if the product is for both non-professional and professional use and the WG/GA Part A and Part B differs in the instructions or the use for the user categories.
However, the word "exclusively" can be removed only if the WG/GAs are conflicting when a particular user category is excluded.
If a product has already been authorised and the WG/GAs on a single label contradict each other, then the authorisation holder can request removal of the word "exclusively" from the WG/GAs. This is done through a minor change procedure.