Commentaries: Art. 13a

For a biocidal product which is authorised in an EU or EFTA Member State (state of origin), the Notification Authority, in consultation with the assessment authorities, shall, on receiving an application to this effect, grant an authorisation for parallel trade if it determines that the biocidal product is identical to a biocidal product which it has already authorised (reference product). 1bis. For a biocidal product that is placed on the market in the state of origin with a notified active substance in accordance with the national provisions there, the Notification Authority shall, on receiving an application to this effect, grant an authorisation for parallel trade provided the applicant can demonstrate that the biocidal product is identical to a reference product.¹
A biocidal product shall be considered identical to the reference product if the following requirements are met:
1. It has been manufactured by the same company, by an associated undertaking or under licence in accordance with the same manufacturing process.
2. The products are identical in specification and content in respect of the active substances and the type of formulation.
3. The products are identical in respect of the non-active substances present.
4. The products are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on human health, animal health or the environment.
³The authorisation for parallel trade shall contain the same conditions for placing on the market and use as in the authorisation for the reference product.²

Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩
Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩

Art. 13a

Footnotes