Directive 98/8/EC of the European Parliament and of the Council (repealed)Dangos y teitl llawn

Article 13 Cooperation in the use of data for second and subsequent applications for authorisation

1. In the case of a biocidal product which has already been authorised in accordance with Articles 3 and 5, and without prejudice to the obligations imposed pursuant to Article 12, the competent authority may agree that a second or subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the second or subsequent applicant can provide evidence that the biocidal product is similar and its active substances are the same as the one formerly authorised, including degree of purity and nature of impurities.

2. Notwithstanding Article 8(2):

(a) an applicant for authorisation of biocidal products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority of the Member State to which he intends making application:

• (a) whether the biocidal product for which an application is to be made is similar to a biocidal product for which authorisation has been granted, and

• as to the name and address of the holder or holders of the authorisation or authorisations.

The enquiry shall be supported by evidence that the prospective applicant intends to apply for authorisation on his own behalf and that the other information specified in Article 8(2) is available;

(b) the competent authority of the Member State, if satisfied that the applicant intends to apply, shall provide the name and address of the holder or holders of former relevant authorisations and shall at the time inform the holders of the authorisations of the name and address of the applicant.

The holder or holders of former authorisations and the applicant shall take all reasonable steps to reach agreement on the sharing of information, so as to avoid, if possible, the duplication of testing on vertebrate animals.

The competent authorities of the Member States shall encourage data-holders to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals.

If it is still not possible for the applicant and holders of former authorisations of the same product to reach an agreement on the sharing of data, Member States may introduce national measures obliging the applicant and holders of former authorisations located within their territory to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilising information, and the reasonable balance of the interests of the parties concerned.