TREACH (KKDIK) BY-LAW (Part 3, Section 2)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
THIRD PART
Data Sharing and Avoidance of Unnecessary Testing
SECOND SECTION
Sharing the existing data for pre-registered substances
ARTICLE 24 – (1) Every potential registrant of a substance shall inquire from the Ministry through Chemicals Registration System in the website of Ministry from 31/12/2023 whether a registration has already been submitted for the same substance. He shall submit all the following information to the Ministry with the inquiry:
- his identity as specified in Section 1 of Annex 6, with the exception of the use sites;
- the identity of the substance, as specified in Sections 2.1 to 2.3.4 of Annex 6;
- which information requirements would require studies involving vertebrate animals to be carried out by him;
(2) Where a substance has previously been registered less than 12 years earlier, potential registrant shall require nessessary information with respect to the Article 11 (a) (6) and (7) from the previous registrant(s) in order to register
- Shall, in the case of information involving tests on vertebrate animals; and
- May, in the case of information not involving tests on vertebrate animals.
(3) 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 11 (a) (6) and (7).
(4) 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. Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.
(5) 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 report.
(6) If there is failure to reach such an agreement, the potential registrant(s) shall inform the Ministry and the previous registrant(s) thereof at the earliest one month after receipt, from the Ministry, of the name and address of the previous registrant(s).
(7) Within one month from the receipt of the information referred to in paragraph 5, the Ministry 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 Ministry, 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 Ministry. 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 may be enforceable in the national courts.
(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.
TURKREACH (KKDIK) BY-LAW
- FIRST PART - General Issues
- SECOND PART - Registration of Substances
- FIRST SECTION - Information Requirements and General Obligation to Register
- SECOND SECTION - Substances Regarded as Being Registered Substances
- THIRD SECTION - Obligation to Register and Information Requirements for Certain Types of Isolated Intermediates
- FOURTH SECTION - Common Provisions for All Registrations
- THIRD PART - Data Sharing and Avoidance of Unnecessary Testing
- SIXTH PART - Evaluation
- SEVENTH PART - Authorization
- EIGHTH PART - Restrictions on the Manufacturing, Placing on the Market and Use Of Certain Dangerous Substances, Mixtures and Articles