As early as possible, but not before the COMMISSION IMPLEMENTING REGULATION of the approval of the AS(s) is published in the Official Journal.

• Provision of services - Fees [de]
• General information [de]

• name of the product or product family:
• name and CAS number of the active substance(s):
• product type(s) involved:
• approval date of the (last) active substance for the (last) product type:
• type of application: national, union authorization, simplified authorization,:
• for NA-APP or SA-APP, could you please indicate in which countries will you respectively apply for a mutual recognition or a notification:
• single product or product family?:
• in the case of a family, number of meta-SPCs and products involved:
• predetermined submission date of the dossier:
• are authorization applications for this / these product(s) already under consideration under the Belgian transitional regime?:
• in case of a single product NA-APP or UA-APP, does the product have the same identity, and composition and use(s) as the product evaluated in connection with the approval for listing of the active substance(s) on the Union list of approved active substances under Regulation No. 528/2012?:
• Are you a SME?:

As early as possible, at the latest 2 years before the planned submission.

• Belgium as the evaluating Member State [en]

• Specifics of proposed uses of the biocidal product (dose, instructions for use, application rate).
• Proposed SPC with intended uses.
• List of studies supporting proposed uses, either completed, ongoing or in the planning.

Please contact the CZCA at least 12 months prior to planned submission of the Union Authorisation in order to discuss possible workload

N/A

Information according to the document "CG-30-2018-06 AP 15.2 Practical guide for BPF pre-submission".

As early as possible, there is no fixed deadline.

• Authorisation of biocidal products [en]

Having a pre-submission consultation before submitting the application is recommended. For the  pre-submission consultation information is needed on the product (100% composition), use description(s), the preliminary draft Summary of Product (family) Characteristics (SPC). Also, an introduction should be provided on the information already available in the dossier and what kind of test(s) are still planned to be performed.

Please contact the Estonian CA for biocides as early as possible, at the latest eight months before the planned submission. 
As EE plans ahead for three years, new potential applications can be submitted in 2026.

• All evaluation fees are available in Biocidal Products Act (Chapter 6) [et]
• All state fees are available in State Fees Act (Chapter 12; Subchapter 3, Division 5) [et]

If you want to request Tukes to act as a reference member state for the evaluation of a national or Union authorisation, send a completed Request for Finland to act as refMSCA -form to Tukes asking Tukes to act as a reference member state or an evaluating member state .  Form is available via the link provided.

at least one year before the application.

• Authorisation of biocidal products [fi]

We request to the applicant:

• the type of UA-APP (single product or product family)
• the active substance(s) and PT(s) supported
• the main uses supported
• in case of a Biocidal Product Family (BPF): the overview of the BPF
• the expected submission date of the application

FR  should be contacted as eCA at least 1 year before the submission of the application.
FR should be contacted preferrably only once an approval decision on an AS/PT is available.

• ANSES [fr]

• Zulassungsverfahren für Biozidprodukte [de]

Pre-submission meeting takes place with the applicant.  The process will be streamlines in case that the applicant has complete dossier so that it can be discussed with the experts

The final decision will be made according to the availability of resources. Applicants can approach the eCA at least 18 months before the submission deadline

We suggest to have a pre-submission meeting (online).

-

N/A

Contact IE CA for full details. 

As early as possible, but no fixed deadline. 

• Authorisation Applications [en]

• date of planned submission of the application
• name of the applicant (including case owner and authorization holder)
• trade name of the biocidal product/family
• active substance/substances
• product-type(s)
• the overview of the BPF
• type of formulation of the biocidal product
• possible SoCs
• target harmful organisms
• categories of users
• list of studies supporting proposed uses, either completed, ongoing or in the planning
• dossier completeness checklist (ref. Annex 3 of the BPR) 

At least one year before the application, but not before the approval of the AS(s), or 1.5 years before the application, but not before a positive BPC opinion on the AS(s).

• Biocidi e presidi medico-chirurgici [it]

First of all, the basic information about the planned application is required: planned submission time, the active substance, possible SoCs, product types and intended uses, and the planned structure of the dossier. The other information is required case-by-case or when it comes closer to the pre-submission meeting.

At least 1.5 years before the submission of the application.

• Biocidal products [en]

As early as possible, but we have no fixed deadline

• Active ingredient/s and quantity;
• Expected submission timeframe;
• Product type/s; Label claim (target organisms);
• Product family (Y/N), if Y, number of members in family; 
• Qualitative and quantitative composition of biocidal product (or product family); 
• Indicated uses, expected exposure routes; 
• User categories (professional, non-professional, general public);
• Substances of concern (y/n), if y, the names/CAS numbers and concentrations in the formulation;
• Human health and/or environmental specification/s in case of identified substances of concern; 
• Exposure via residues in food/feed/drinking water expected (y/n). If (y), are MRLs set for the active substance(s) (y/n);

As early as possible, but we have no fixed deadline

• Biocidal Product Application [en]
• Provision of Services - Fees [en]

As early as possible, but no fixed deadline. 

• Biocidal products in Norway [en]

• name of the applicant (preferably including case owner and future authorization holder)
• trade name of the biocidal product/ family*
• active substance/substances
• type of formulation of the biocidal product
• product-type
• target harmful organisms
• categories of users
• more detailed information concerning structure of the family (eg. how many meta-SPC are included)

at least 1 year before the submission of the application

• EUROPEAN PROCEDURES [en]

• Ordonanta-de-urgenta-nr-41-2019- [ro]

active substance(s), PT(s), BP/BPF

At least 2 years before the submission of the application.

N/A

• Applicant
• Company UUID
• Dossier type (Single Biocidal Product/BPF)
• Active substance name
• Product type
• Date of approval of the active subtance
• Date of planned submission of the application

As early as possible, at the latest 2 years before the planned submission.

• Union authorisation [en]

Please, see the information from the eCA

Please, see the information from the eCA

• Information from the eCA [es]

Information listed in the form “Information on your intended application in Sweden” should be provided. The form is available for download on the website of the Swedish Chemicals Agency via the link provided.

It is highly recommended to submit the request well in advance, preferably 12 months before the submission of an application. We will however not be able to process requests submitted prior to the publication of the approval decision for the active substance.

• Apply for authorisation for biocidal products [en]

The potential applicant must send us a completed checklist indicating the status of the different endpoints (product dossier which mainly corresponds to Annex III of the BPR). The checklist reflects the completeness of a given dossiers and will be taken into account for the decision to accept the dossier and the planning.

We expect potential applicants to contact us as early as possible, but not before a positive BPC opinion on the active substance has been issued.

• Application for an Union authorisation [en]

•  Applicant/Company UUID
•  Intended product name or BPF name
•  PT(s)
• Single product or BPF (in case of BPF: indicate number of metaSPCs   -and products)
• Intended date of submission

An eCA agreement with the Ctgb can be requested as soon as the implementing regulation regarding the approval of the active substance(s) for the relevant PT(s) is published in the European Journal, stating the approval date in the annex. A pre-submission meeting with the experts of the Ctgb is obligatory before submission of the dossier. For this purpose, it is recommended to contact us at least 6 months before the submission of the application. 

• Biocidal products [en]