What is a Same Biocidal Product?
A “same biocidal product” is a regulatory concept introduced under EU BPR through an amendment regulation (Commission Implementing Regulation (EU) 2016/1802). This incorporates an alternative authorisation route for biocidal products which have already been authorised or are under evaluation for authorisation by an EU Member State Competent Authority (CA). This process is also available under GB BPR for products authorised or under evaluation by the HSE for authorisation.
Under this process, an applicant may submit their own biocidal product authorisation application for a product which is authorised or under evaluation for authorisation. In this submission, the applicant refers to the product authorisation dossier submitted for the “reference product” (or “prospective reference product” for those which are still under evaluation for authorisation). The applicant’s product must be identical to the reference product to qualify for a same biocidal product authorisation. In this article, we will discuss the advantages and disadvantages to the Same Biocidal Product authorisation.
Advantages of Same Biocidal Product Authorisation
There are many advantages to submitting the same biocidal product authorisation compared to a BPR product authorisation. These include:
Significant reductions in the associated evaluation fees charged by the evaluating authorities. For example, for a Union authorisation for a single biocidal product, ECHA charges 80,000 Euros while a same biocidal product authorisation submitted for Union authorisation costs 2,000 Euros in evaluation fees. Smaller savings are available for national authorisations but this depends on the evaluating member state.
The data requirements for a Same Biocidal Product authorisation is often minimal as the vast majority of the information will be provided for the reference product through a Letter of Access (LoA) from the data owner. An LoA may require the payment of a fee but this is often much cheaper than generating a full data package allowing for significant savings to applicants.
An applicant can submit a same biocidal product application for a single biocidal product or biocidal product family which is identical to a product or product family which is authorised or under evaluation. You can also apply for a single meta-SPC within a biocidal product family or several Meta-SPCs as part of a biocidal product family providing all Meta-SPCs are under evaluation or authorised within an approved biocidal product family. This allows applicants a lot of choice when deciding which products they wish to authorise under a same biocidal product application.
If approved, the applicant is granted an independent authorisation to place that biocidal product on the market. This can be a union authorisation, individual national authorisations in specific member states or multiple member states through a mutual recognition process however, the reference product must be authorised or under assessment in all desired countries. The resulting authorisation will have the same expiry date as the reference product however, changes or cancellation of a same biocidal product authorisation can be made independently of the reference product.
Disadvantages of Same Biocidal Product Authorisation
Now we will consider some disadvantages of submitting a Same Biocidal Product authorisation application. These include:
Applicants for a same biocidal product authorisation may not have full access to all of the information on the reference product. As we have already noted, it is typical for a prospective applicant to establish an agreement with the reference product manufacturer to use their data through an LoA. This is beneficial to reduce data generation costs but it does mean that the applicant cannot review or see the data before submission. This means that, if any issues arise during the evaluation of the reference product, this will impact any same biocidal products submitted based on that dossier and if the reference product is not authorised under the BPR, all same biocidal products will also be affected by this non-approval.
Product manufacturers may require a sales agreement as part of the LoA discussions. This may limit component supplier options for suppliers of Same Biocidal Products. If the product manufacturer changes supplier for the reference product, this would also need to be communicated for any same biocidal product authorisations granted based on that product.
when a same biocidal product authorisation is granted, the expiry date is the same as the expiry date of the reference product. This can result in a same biocidal product authorisation being valid for only a very short time before requiring renewal. Applicants should ensure that they are fully aware of the expiry date of the reference product before they submit an application and, if possible, seek confirmation from the manufacturer that a renewal dossier will be submitted.
To benefit from the same biocidal product authorisation, the applicant must ensure that their product or product family is identical to the reference product. A same biocidal product can only be sought for a product in countries where the reference product has been authorised or is under evaluation for authorisation. Where an applicant wishes to submit a Same Biocidal Product application for a country where the reference product is not already authorised, this would have to be a full biocidal product authorisation or to request the product manufacturer to submit a mutual recognition application for that member state to allow a same biocidal product submission to be used.
How can Yordas help
Yordas offers expert assistance in all regulatory aspects of the BPR including the development of regulatory strategy and preparation of all forms of product dossier including Same Biocidal product applications. As part of this service, we can coordinate and broker agreements between product manufacturers and applicants and as an independent third party we can also handle data confidentially, as required. We have a wealth of expertise in preparing supporting documentation for these applications and can also provide bespoke advice for data generation and expert study monitoring if required. For more information about or to learn more about this or any other aspect of the BPR, please feel free to contact us or visit our website. To stay informed about future regulatory changes and obligations, subscribe to our newsletter.