4.5. Use of the same trade name in different products

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Presentation transcript:

4.5. Use of the same trade name in different products Background: - E-consultation to the CG: "Can two different products belonging to two different PTs and having two different authorisation numbers have the same trade name?" First discussion in closed session; divergent views of MSs: "Majority view": it seems contrary to article 69 of BPR and the principle set in the changes Regulation (Annex I, title 1, section 1,point 1): i.e. when adding a new trade name, there should be no confusion with the trade name of another product. "Minority view": a biocidal product is identified by the "trade name + authorization holder + the unique authorisation number". The principle set in the changes Regulation is only applicable to changes, not to first authorisations.

4.5. Use of the same trade name in different products Background: - E-consultation to the CG: "Can two different products belonging to two different PTs and having two different authorisation number have the same trade name?" Second discussion in open session (May 2018); seek views of ASOs (Cefic/Aise/FECC) No agreement was reached: the discussion had to be sent to the CA meeting ASOs were invited to provide written comments in order to prepare the discussion at the CA meeting (see FECC comments).

4.5. Use of the same trade name in different products Analysis: There might be very different scenarios: 1.- Similar products (Professional use only)/similar PTs (main Group 3)/same AH: no confusion for user; no conflict for the AH 2- Similar products (Professional use only)/similar PTs (main Group 3)/different AHs: no confusion for user; conflict for the AHs 3- Similar products (general public only)/similar PTs (main Group 1)/different AHs: possible confusion for user; conflict for the AHs

4.5. Use of the same trade name in different products Analysis: Some key objectives to consider: 1.- Ensure accurate information to users (particularly to the general public); 2.- Avoid possible mistakes by users (particularly to the general public); 3.- Ensure a level playing field for applicants 4.- Facilitate enforcement

4.5. Use of the same trade name in different products Analysis: Legal provisions in the BPR and Changes Regulation (without prejudice of more specific legislation on proprietary trade names): 1.- Art. 69(2) of the BPR: "… AHs shall ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy, …" The trade name is a key identifier for users (name of the AH or authorisation numbers are normally not checked – specially by the general public) The same trade name in two very different products might lead to some risks, particularly when used by the general public (e.g. need to wear PPE)

4.5. Use of the same trade name in different products Analysis: Legal provisions in the BPR and Changes Regulation (without prejudice of more specific legislation on proprietary trade names): 2.- Changes Regulation: allows changing or adding a trade name where there is no risk of confusion with the names of other biocidal products. Policy objective: to avoid "confusion" in terms of trade names; Avoiding "confusion" seems to implicitly exclude the possibility of having the same trade name in two different products Such changes require scrutiny by CAs before implementation; this indicates a kind of "preventive" approach that could be equally valid at the first authorisation stage (consistency).

4.5. Use of the same trade name in different products Need to find a harmonised way forward: Contributing to achieving key objectives in the BPR in terms of information to users and safety, Ensuring consistency between the approach at the first authorisation or in the context of application for changes. "Extreme" example (in line of the "minority" position of some MSs): All the products in a BPF could have the same trade name at the first authorisation, since they could be identified by looking at the name of the AH and their individual authorisation numbers... But this would not be possible in the context of an administrative change later on….

4.5. Use of the same trade name in different products Need to find a harmonised way forward: Ad hoc solutions can be found for some specific cases: 1.- Similar products (Professional use only)/similar PTs (main Group 3)/same AH: The two authorisations are merged into one single authorisation with the same trade name; e.g. "Killer" (PT "x" & "y"), or A suffix is added to each PT; e.g. "Killer-x" & "Killer-y" 3- Similar products (general public only)/same PTs (main Group 1)/different AHs: In case of well-known "generic names", a suffix is added to the name of the active substance; e.g. "Sodium hypochlorite 17% - Company A" & "Sodium hypochlorite 17% - Company B"