Parallel trade permits under the EU Biocides Regulation 528/2012 (EU BPR)

This pages provides information about the requirements and process for the granting of parallel trade permits for the placing of biocidal products on the market in the UK under Article 53 of the EU Biocides Regulation 528/2012 and applies from 1 September 2013.

Introduction

Parallel trade permits allow a company to import and place on the UK market a product already authorised in another Member State (Member State of Origin) under the EU Biocides Regulation (EU BPR), provided an identical product is already authorised under EU BPR in the UK (reference product).

The provision is internal market driven but does not reduce the level of protection for the environment or public health.

How to apply

Application must be made in writing to HSE and must contain the following information

• name and authorisation number of the biocidal product in the Member State of origin;
• name and address of the competent authority of the Member State of origin;
• name and address of the authorisation holder in the Member State of origin;
• original label and instructions for use with which the biocidal product is distributed in the Member State of origin;
• name and address of the applicant;
• name to be given to the biocidal product to be distributed in the UK;
• a draft label for the biocidal product intended to be made available on the UK market in English;
• name and authorisation number of the reference product in the UK.

HSE may also ask for a sample of the biocidal product which is intended to be introduced if it is considered as necessary.

Sifting the Application

HSE will then conduct an initial assessment of the information to determine that it meets the requirements for the application type applied for and whether any additional data is needed. We will also determine how much it may cost.

The Applicant will then be invoiced for the estimated fee to undertake the work.

Paying the Estimated Fee

Applicants should pay the request within 30 days of the invoice date. If an applicant anticipates a delay in payment please inform us as soon as possible.

Applications will not be processed until the requested fee has been received in full.

HSE accepts payments by either cheque or bank transfer. The full payment details/methods will be outlined in your invoice

Evaluation of application

HSE will determine if the biocidal product can considered as identical to the UK reference product if all the following conditions are met:

• they have been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process;
• they are identical in specification and content in respect of the active substances and the type of formulation;
• they are the same in respect of the non-active substances present; and
• they are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health, animal health or the environment.

If required HSE will request additional information from Competent Authority in the Member State of origin

Outcome of the evaluation

On completion of the evaluation of an application a decision will be made as to whether or not the biocidal product can considered as identical to the reference product.

Successful Applications

If we determine that the biocidal product can considered as identical to the reference product a parallel trade permit will be granted.

The parallel trade permit shall

• prescribe the same conditions for making available on the market and use as the authorisation of the UK reference product;
• be valid for the duration of authorisation of the UK reference product.

If the authorisation holder of the UK reference product applies for the cancellation of the authorisation of that reference product in accordance with Article 49 of EU BPR and the conditions for granting an authorisation of Article 19 of EU BPR are still fulfilled, the validity of the parallel trade permit shall expire on the date on which the authorisation of the UK reference product would normally have expired.

Parallel trade permit holders have the same duties under Article 47 of EU BPR to notify HSE (and other member state Competent Authorities) of any unexpected or adverse effect as other authorisation holders.

Parallel trade permit maybe cancelled or amended by HSE (and other member state Competent Authorities in their country) or at the request of the parallel trade permit holders in the same way that authorisation maybe cancelled or amended under Articles 48 to 50 of EU BPR.

HSE may also withdraw the parallel trade permit if the authorisation of the introduced biocidal product is withdrawn in the Member State of origin because of safety or efficacy reasons.

Unsuccessful Applications

If we determine that the biocidal product cannot be considered as identical to the reference product, a parallel trade permit will not be granted and the product cannot be made available on the UK market.

The applicant will have to submit a new application and pay the relevant fee to have the opportunity to modify/update their application in order to make it acceptable.

Calculating the actual UK costs

We will calculate the actual cost for evaluating the application based on the total time spent. If the cost has gone beyond the initial estimated fee, then a top-up fee will be requested. Alternatively, if the cost is less than the initial estimated fee, an appropriate refund will be given. This two stage fee approach is required as HSE’s evaluation costs need to be fully cost recovered.