Requirements and Structure
An application for authorisation of a biocidal product (BP) - or registration of a low risk BP - consists of an application form and an application dossier.
- to the application from in R4BP
Application Form
The form consists of two parts. For part I general information concerning the biocidal product and on the member states in which applications are intended (applications for first-authorisation or mutual recognition) are necessary. For this purpose the European Commission developed the database R4BP (Registration for Biocidal Products). Applicants for authorisations of products are obliged to use this platform to generate the first part of their application form for both authorisation and mutual recognition applications. Part II should be completed in German language and its optional submission is necessary at the point of time the application is submitted.
Application dossier for mutual recognition
Within the application period of 3 months according to the Existing Active Substance Ordinance (BGBl. II Nr. 353/2008) § 2 (1) No 2 and § 4 (1) No 2 a written notification of a subsequent submission of an application for mutual recognition of authorisation/registration of the BP according to § 2 (2) and § 4 (2) must be submitted to the Austrian Competent Authority.
At submission of the application the information has to completed or up-dated according to § 13 or § 14 of the Act on Biocidal Products: the application from, part II, a certified copy of the first authorisation in German or English language (the German version does not have to be translated by an juridically authorized translator), the product assessment report (PAR), the summary of product characteristics (SPC) and a copy of the payment form of the fee (GG+VPG) to the Austrian Competent Authority. If as a result of the first evaluation/registration changes in the Safety Data Sheet or the label have been made, updated versions in German language are needed. In addition if the Summary Dossier has been corrected also an updated electronic version is necessary.
Application dossier for first-authorisation/first-registration
The dossier contains a risk assessment, summary assessments of studies as well as the study reports themselves and further data if applicable.
For authorisations according to § 8 (4) and registrations according to § 9 (2) of the BP Act the above information on the BP as well as the active substance(s) contained in this product, have to be submitted to the competent authority .The use of specific studies which are owned by (an)other applicants is only permitted with his/her written approval ("Letter of Access"). In this case, the submission of the original study reports is not necessary.
The information and data must be adequate to allow for the check whether the authorisation or registration requirements according to § 10 of the BP Act have been complied with and correspond to the current state of scientific and technical knowledge as well as to the requirements of Annexes II and III of the Biocidal Products Directive (BPD).
The applicant has to carry out a risk assessment and a summary assessment of the studies (according to Annexes II and III of the BPD). For the risk assessment of the BP also an assessment of substances of concern in the product is mandatory. The principles of this assessment are stipulated in Annex VI of the BPD. Detailed instructions for the risk and efficacy assessment can be found via the infobox LINK.
As formats for the summary of studies and the risk assessment, the templates for the Summary Dossier, as specified in the "TNsG on Dossier Preparation" may be used until further notice. A hard copy of the application dossier and an electronic version is required.
Intended use of the BP is not covered by Annex I/IA
If the intended use of a BP for which an application for authorisation/registration is submitted is not covered by the evaluation for inclusion of the active substance(s) in Annex I/IA of the BPD (requirements see Assessment Report), an additional evaluation of the active substance has to be carried out and to the extent necessary corresponding changes have to be made to the entry in Annex I/IA of the BPD and/or to the original Assessment Report on the active substance(s).
Contact
Study reports have to be submitted, together with all other information and data required (e.g. on risk and efficacy assessment) as well as the corresponding application form, to the following authority:
Federal Ministry of Agriculture, Forestry, Environment and Water Management, Department V/3, Stubenring 1, A-1010 Vienna;
E-mail: 
Federal Ministry, Cc: BP Zulassungen