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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)
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1.The Agency shall establish and maintain an information system which shall be referred to as the Register for Biocidal Products.
2.The Register for Biocidal Products shall be used for the exchange of information between competent authorities, the Agency and the Commission and between applicants and competent authorities, the Agency and the Commission.
3.Applicants shall use the Register for Biocidal Products to submit applications and data for all procedures covered by this Regulation.
4.Upon submission of applications and data by applicants, the Agency shall check that these have been submitted in the correct format and notify the relevant competent authority accordingly without delay.
Where the Agency decides that the application has not been submitted in the correct format, it shall reject the application and inform the applicant accordingly.
5.Once the relevant competent authority has validated or accepted an application, it shall be made available via the Register for Biocidal Products to all other competent authorities and to the Agency.
6.The competent authorities and the Commission shall use the Register for Biocidal Products to record and communicate the decisions they have taken in relation to the authorisations of biocidal products and shall update the information in the Register for Biocidal Products at the time such decisions are taken. The competent authorities shall, in particular, update the information in the Register for Biocidal Products relating to biocidal products which have been authorised within their territory or for which a national authorisation has been refused, amended, renewed or cancelled, or for which a parallel trade permit has been granted, refused or cancelled. The Commission shall, in particular, update the information relating to biocidal products which have been authorised in the Union or for which a Union authorisation has been refused, amended, renewed or cancelled.
The information to be introduced into the Register for Biocidal Products shall include, as appropriate:
(a)the terms and conditions of the authorisation;
(b)the summary of the biocidal product characteristics referred to in Article 22(2);
(c)the assessment report of the biocidal product.
The information referred to in this paragraph shall also be made available to the applicant through the Register for Biocidal Products.
7.In the event that the Register for Biocidal Products is not fully operational by 1 September 2013 or ceases to be operational after that date, all obligations in relation to submissions and communication placed upon Member States, competent authorities, the Commission and applicants by this Regulation shall continue to apply. With a view to ensuring the uniform application of this paragraph, particularly with regard to the format in which information may be submitted and exchanged, the Commission shall adopt the necessary measures in accordance with the examination procedure referred to in Article 82(3). Those measures shall be limited in time to the period strictly necessary for the Register for Biocidal Products to become fully operational.
8.The Commission may adopt implementing acts laying down detailed rules on the types of information to be entered in the Register for Biocidal Products. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 82(2).
9.The Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down supplementary rules for the use of the Register.
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