Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 12 U.K. Use of data held by competent authorities for other applicants

1. Member States shall not make use of the information referred to in Article 8 for the benefit of a second or subsequent applicant:

(a) unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information, or

(b) in the case of an active substance not on the market on the date referred to in Article 34(1), for a period of 15 years from the date of first inclusion in Annex I or IA, or

(c) in the case of an active substance already on the market on the date referred to in Article 34(1):

(i)

for a period of 10 years from the date referred to in Article 34(1) for any information submitted for the purposes of this Directive, except where such information is already protected under existing national rules relating to biocidal products. In such cases, the information shall continue to be protected in that Member State until the expiry of any remaining period of data protection provided for under national rules, up to a maximum of 10 years from the date referred to in Article 34(1);

(ii)

for a period of 10 years from the date of entry of an active substance onto Annex I or IA for information submitted for the first time in support of the first inclusion in Annex I or IA of either the active substance or an additional product type for that active substance,

(d) in the case of any further information submitted for the first time for any of the following:

(i)

variation of the requirements of the entry on Annex I or IA;

(ii)

maintenance of the entry of Annex I or IA

for a period of five years from the date of decision following receipt of further information unless the five-year period expires before the period provided for in paragraphs 1(b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.

2. Member States shall not make use of the information referred to in Article 8, for the benefit of a second or subsequent applicant:

(a) unless the second or subsequent applicant has the written agreement in the form of a letter of access of the first applicant that use may be made of such information; or

(b) in the case of a biocidal product containing an active substance not on the market on the date referred to in Article 34(1) for a period of 10 years from the date of first authorisation in any Member State, or;

(c) in the case of a biocidal product containing an active substance already on the market on the date referred to in Article 34(1);

(i)

for a period of 10 years from the date referred to in Article 34(1) for any information submitted for the purposes of this Directive, except in the case where data are already protected according to existing national rules relating to biocidal products, in which case such data shall be protected in that Member State until the expiry of any remaining period of data protection provided for under those national rules, up to a maximum of 10 years from the date referred to in Article 34(1);

(ii)

for a period of 10 years from the date of entry of an active substance onto Annex I or IA, for information which is submitted for the first time in support of the inclusion in Annex I or IA either of the active substance or of an additional product type for that active substance;

(d) in the case of any data submitted for the first time for either of the following:

(i)

variation of the conditions of authorisation of a biocidal product;

(ii)

submission of data necessary to maintain entry of an active substance onto Annex I or IA

for a period of five years from the date of first receipt of further information, unless the five-year period expires before the period in paragraphs (b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.

3. For decisions to be taken in accordance with Article 10(5), the information referred to in paragraphs 1 and 2 can be used by the Commission, the Scientific Committees as referred to in Article 27 and the Member States.