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1. Where a substance has previously been registered
less than 12 years earlier as referred to in Article 26
(3), the potential registrant:
(a) shall, in the case of information involving tests on vertebrate animals; and
(b) may, in the case of information not involving tests on vertebrate animals,
request from the previous registrant(s) the information he requires with respect to Article 10
(a)(vi) and (vii) in order to register
2. When a request for information has been made according to paragraph 1, the potential and the previous registrant(s) as
referred to in paragraph 1 shall make every effort to reach an agreement on the sharing of the information requested by the
potential registrant(s) with respect to Article 10
(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of
the arbitration order.
3. The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information
are determined in a fair, transparent and non-discriminatory way. This may be facilitated by following cost sharing guidance
based on those principles which is adopted by the Agency
in accordance with Article 77
(2)(g). Registrants are only required to share in the costs of information that they are required to submit to satisfy their
4. On agreement on the sharing of the information, the previous registrant shall make available to the new registrant the
agreed information and shall give the new registrant the permission to refer to the previous registrant's full study
5. If there is failure to reach such an agreement, the potential registrant(s) shall inform the Agency
and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency
, of the name and address of the previous registrant(s).
6. Within one month from the receipt of the information referred to in paragraph 5, the Agency
shall give the potential registrant permission to refer to the information requested by him in his registration
dossier, subject to the potential registrant providing, upon request by the Agency
, proof that he has paid the previous registrant(s) for that information a share of cost incurred. The previous registrant(s)
shall have a claim on the potential registrant for a proportionate share of the cost incurred by him. Calculation of the proportionate
share may be facilitated by the guidance adopted by the Agency
in accordance with Article 77
(2)(g). Provided he makes the full study
report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for
an equal share of the cost incurred by him, which shall be enforceable in the national courts.
7. An appeal may be brought, in accordance with Articles 91
, against Agency
decisions under paragraph 6 of this Article.
8. The registration
waiting period in accordance with Article 21
(1) for the new registrant shall be extended by a period of four months, if the previous registrant so requests.