Doruk Sistem - TURK / REACH
KKDIK(TURK REACH) FAQ
Frequently Asked Questions About KKDIK V
8.1 Do I have to register the substances in the goods?
According to the KKDIK Regulation, the registration obligation for substances in articles is in question if all the following criteria of Article 8(1) and Article 8(6) are met: – If the substance is designed to release under normal and foreseeable conditions of use, if the total amount of substance in the article exceeds 1 ton per year per manufacturer or importer, and if the substance has not been previously registered for a specific area of use.
8.2 Under what conditions and when should I report 'substances of high concern' present in the goods?
Substances that meet the criteria in Article 47 of the KKDIK Regulation are considered to be substances of high concern. For substances of high concern in the goods, notification must be made according to Article 8 (2) of the KKDIK Regulation and if the following conditions are met:
- The substance is included in the candidate list of authorized substances and,
- If the concentration of the substance in the articles is greater than 0.1 % by weight,
- The total amount of substances in the articles (i.e. in articles containing more than 0.1 % by weight of 'substances of high concern') is more than 1 ton per producer or importer per year,
- The substance has no previous registration for this specific use. However, the manufacturer or importer is able to prevent human and environmental exposure during its use and disposal under normal and foreseeable conditions
There is no obligation to make a notification.
The notification of the substances of high importance in the goods shall be made within 6 months (at the latest) starting from June 1, 2011, from the date the relevant substance is added to the candidate list for substances subject to authorization (KKDIK Regulation, Article 8(7)). The supplier shall provide the information of the substances in the candidate list to the buyers (KKDIK Regulation, Article 29). As substances are identified according to the KKDİK Regulation, Article 47 criteria, the candidate list is continuously updated.
8.3 In Article 8(6), does the provision 'the provisions of paragraphs one to five shall not apply to substances in articles previously registered for the same use' refer to the same supply chain or different supply chains?
Provided that the substance is registered by any manufacturer/importer for this specific use, the provisions of paragraphs one to five of Article 8 of the KKDİK Regulation do not apply.
8.4 What is the designed release of the substance from the article?
If the substance does not perform its main function when it is not released and only performs an accessory function, the release of the substance from the article is designed. For example, in scented children’s toys, the odorants in the toys are released to fulfill the auxiliary function of imparting the odor. Substances released as a result of the wear and tear and wear and tear of articles, or as unavoidable side effects of the article performing its function, are generally not designed releases because the release does not fulfill the function in itself.
Furthermore, the designed release of the substance from the article occurs under normal and foreseeable conditions of use. This means that the release of the substance occurs during the period of use of the article. Therefore, a release of a substance occurring during the production or disposal stages of the article is not an engineered release. Similarly, releases that occur accidentally or due to improper or unauthorized use of the article cannot be considered an engineered release because they do not occur under normal and foreseeable conditions of use.
8.5 Can semi-finished steel products such as plates, sections and billets be treated as articles?
The point of transition from substance/mixture to article during the processing of steel and semi-finished steel products is determined based on the function of the object. An object is considered an article if it can be clearly concluded that its shape/surface/design is more relevant to the function of the object compared to its chemical composition. If the shape, surface or design of the object is equal to or less important than its chemical composition, the object is a substance or mixture. In doubtful cases, whether semi-finished steel products constitute articles is better determined by the questions in Section 2.4 of the Guidelines on the Requirements for Substances in Articles. However, it is up to the companies to examine their specific situation and decide whether their products can be considered as articles.
8.6 According to Article 8(2) of the KKDIK Regulation, is the notification for Substances of High Importance in articles subject to a fee?
The notification of high-significance substances in goods is free of charge.
8.7 Is it necessary to notify if the production/import of goods containing Highly Important Substances has stopped?
No notification is required if the production/importation was finished before the substance of high concern was included in the Candidate List of Substances of High Concern for Authorization or before the notification obligation started (before December 1, 2010 or June 1, 2011 for substances included in the list or 6 months after the substance was included in the Candidate List). However, according to Article 29 of the KKDIK Regulation, at least sufficient information for the safe use of the article containing the name of the substance must be provided to the recipient of the article or to the consumer upon the consumer’s request.
8.8 Should I assess the tonnage produced/imported according to Article 8(2) of the KKDIK Regulation before the Substance of High Concern is included in the Candidate List of Substances of High Concern for Authorization?
For articles produced/imported for at least three consecutive years, it is reported in tonnes corresponding to the average tonnage of the substance in the article over these three full years. If the substance in the article has been produced/imported for only 2 years, the average of these two years should be reported. However, if the substance in the article has been produced/imported since the previous calendar year, the tonnage will be calculated only on the basis of the previous calendar year without averaging.
For example, substances that were on the Candidate List of Substances of Very High Concern before 1 December 2010 must be notified by the manufacturer or importer by 1 June 2011. The producer or importer shall provide the average tonnage for the following three or two consecutive years or the tonnage for 2010, depending on how many consecutive years the article has been imported or produced. Thus, for the notification of the substance in the article, the tonnage calculation for the declaration of the substance in the article includes situations such as the volumes of the substance under consideration before its inclusion in the candidate list.
It is recommended to notify as soon as the threshold of 1 ton is crossed in the current year when the production/importation of the goods starts. In this case, the expected tonnage range for the whole year is indicated.
8.9 Do producers and importers of goods make only one notification according to Article 8(2) of KKDIK, or should the notifications be updated?
While it is mandatory to update the register of substances in articles with new relevant information, there is no legal obligation to update the ‘notification of substances in articles’ file. Nevertheless, the Ministry advises notifiers to update their notification dossiers in case of changes in the information notified to it. It is also in the interest of the notifier to keep its dossier updated, as the Ministry may take a decision on the submission of a registration application by manufacturers/importers of articles according to Article 8(5) of the KKDIK Regulation based on the notification.
8.10 How can manufacturers or importers of articles find information on whether the substance of high concern has been previously registered for use in a particular article and whether the exemption in Article 8(6) of the KKDIK applies?
The possibilities for companies to verify whether the substance is registered for its specific use are described in the Guidelines on the Requirements for Substances in Articles. It should be noted that it is mandatory to ensure both the identity of the substance and the uniformity of the use. The Guidance on the Requirements for Substances in Articles is available from the helpdesk.
Such sources of information are, for example, safety data sheets, communication in the supply chain and trade associations. The amount of information available to producers of articles is often greater than that available to importers of articles. In particular, it may be easier for importers of articles to document whether the specific use of the substance in a particular article has been previously registered than to notify for substances of high concern in the article.
9.1 What is the purpose of data sharing?
The rules on data sharing and avoiding unnecessary testing are contained in Part 3 of the KKDIK Regulation. As stated in Article 23 of Part 3, the purpose of these rules is to reduce testing on vertebrate animals (these tests should be carried out as a last resort) and to avoid duplication of tests, thus reducing the cost to industry and increasing the efficiency of the registration system.
9.2 What is the purpose of the Article Knowledge Exchange Forum (MBDF)?
The purpose of the MBDF is to facilitate the sharing of information required for registration to avoid duplication of efforts between potential registrants of the same substance. Another objective is to agree on the classification and labeling information of the substance. The MBDF also serves as a platform for data subjects to share their data/studies on the substance. In addition, if the available information is not sufficient for registration, the MBDF jointly identifies the work that needs to be done.
9.3 How can communication be coordinated within the MBDF?
Having one participant as a coordinator greatly facilitates knowledge sharing within the MBDF. This participant can make suggestions on ways to share information about the substance. As defined in Article 12 of the KKDIK Regulation, MBDF participants can agree on a registration leader who will undertake the organization of the information exchange and the preparation of the joint presentation in the first phase.
If the information to be shared is considered commercially confidential by one or more potential registrants (e.g. due to impurity content that may be indicative of the production process), the lead registrant may propose the signing of a confidentiality agreement or the engagement of an independent third party to handle confidential information on behalf of the potential registrants. Any other form of organization is equally possible as long as it is agreed upon by all MBDF participants.
Detailed information on how to organize the MBDF and how to accelerate communication can be found in the ‘Data Sharing Guide’ section 3.10- ‘MBDF Formation Manager’.
9.4 How is the MBDF created and what is the role of EINECS in substance identification?
The principles on how and when to create an MBDF, how to determine the sameness of substances (i.e. whether the quantitative or qualitative composition of a substance leads to the conclusion whether it should be considered as one and the same substance with one name in accordance with the purpose of the KKDIK) and thus whether they should be considered in the MBDF are described in the Data Sharing Guidance Chapter 3.2 – Creating MBDFs. It also describes the coordination (facilitation) of communication within the MBDF and at what point data subjects should participate in the MBDF.
All potential registrants of the same substance should establish an MBDF under KKDIK based on the provisions in the KKDIK Regulation and also as detailed in the Chemical Substance Nomenclature Guide. If a substance has an EINECS number, this normally means that an MBDF will be created for an EINECS entry. However, one EINECS entry may correspond to more than one substance or more than one EINECS entry may correspond to one and the same substance.
Substance identification, whether substances should be considered as the ‘same’ substance or not, and participation in the same MBDF are the subject of ‘sameness’ discussions that should be held prior to MBDF formation. It should be noted that the KKDIK Regulation does not include a definition of ‘sameness’ and the Ministry does not take an official role in the formation of the MBDF or in the determination of sameness to validate ‘sameness’ discussions.
Pre-MBDF registrants must enter into negotiations to agree on the sameness of the substance. Consequently, an MBDF is established when the potential registrants of a substance on the list of substances for which a pre-MBDF is registered agree that they actually manufacture/import or intend to manufacture/import the same substance.
Any decision on substance identity and substance name should be carefully checked to ensure that it is consistent with the substance identity rules described in the Chemical Substance Nomenclature Guidelines.
Refusal to share data within the MBDF may in some cases result in the item not being registered. Splitting an EINECS entry into several substances, where necessary, may result in invalid registrations, requiring re-preparation and submission of registration dossiers for all relevant substances and re-payment for registration. Therefore, in case of doubt, it is advisable to share the data to be used for the EINECS entry as widely as possible (although the KKDIK Regulation does not strictly require this) and, at the same time, to interpret the substance definition in a limited way, i.e. to submit more than one separate dossier. When deciding not to split EINECS entries, it should be considered whether the data/information provided is sufficient for all variables and substance forms.
In case of major problems, it is advisable to contact the Ministry for clarification
9.5 How to manage Pre-MBDF?
Pre-MBDFs are supported by the Ministry through the article websites. Information on the formation of MBDFs is provided in two free writing areas allocated on the article website. In the first free area, writing rights are granted only to the MBDF formation manager. In the second free space, all pre-MBDF registrants of the article have the right to write. All messages in these two areas will be the sole responsibility of the authors and the Ministry will not take any action regarding their content.
It is recommended that the MBDF formation administrator uses the first field to communicate messages about the MBDF formation and to provide information and contact details for further means of communication. The second field allows other pre-registrants to comment. Both fields allow the use of limited characters and should only be used for key messages, contact details and/or communication tools. In addition, pre-registrants can exit the pre-MBDF to indicate that they are no longer interested in the registration (see FAQ 9.14).
Potential registrants should start MBDF formation as soon as possible to allow sufficient time to organize data sharing and prepare the registration dossier; this is particularly important in light of the 30 November 2010 registration deadline for high volume substances. The Guidance on Data Sharing (Chapter 4.2) explains in detail how and when to set up an MBDF.
9.6 Who can be a data subject in the MBDF?
Section 4.2 MBDF participants of the Data Sharing Guidelines explains in detail who can and should be MBDF participants. The roles of data subjects are also described there.
A ‘data subject’ is a person who has information/data about an item and wants to share it. Data subjects register with the CDS to be a participant in the MBDF related to this article.
‘Data subjects’ include the following:
- Manufacturers, importers and sole representatives of foreign producers of less than 1 tonne of substance per year who have not made a preliminary MBDF registration.
- Sub-users of articles.
- Third parties with knowledge of the substances
- Before 1 June 2018, any manufacturer or exporter or sole representative of a manufacturer based abroad, or manufacturers or importers of articles designed to release under normal or foreseeable conditions of use, who has registered the substance automatically becomes a data subject. This includes users who have pre-registered and decided to register before the relevant registration deadline, as well as users who have not pre-registered.
Any party that submits information to the Ministry under the Regulation on the Licensing of Plant Protection Products or the Regulation on Biocidal Products that meets the conditions set out in Article 16 of the KKDIK Regulation.
9.7 How will costs be shared?
Collection of cost-causing data and data sharing requires some form of cost sharing. According to Article 24(3) of the KKDIK Regulation, parties sharing data should make every effort to ensure that all costs for information sharing are fair, transparent and non-discriminatory. Cost sharing information for tests required as a result of a ministerial decision can be found in Article 44 of the KKDIK Regulation.
The agreement on cost sharing requires the parties to agree on the following:
- Reliability, relevance and sufficiency of data ('data quality'),
- The economic value of data ('data valuation'),
- How the agreed cost will be shared between the parties ('cost sharing and compensation')
These guidelines should primarily serve as a checklist for all parties involved to identify relevant factors when organizing data quality reviews, data evaluation and other cost-sharing activities. Registrants should only share the cost of information that is necessary for their own registration requirements. Therefore, companies cannot be forced to pay for data they do not need. Firms cannot be forced to pay before they actually need the information on their tonnage ranges. But if a potential registrant requests the data in advance, they must pay as soon as they receive it. Other guidelines can also be taken into account. In general, it is advisable to agree on cost sharing before the available information is shared by the participants.
Cost sharing regarding the implementation of Articles 24 and 26 of the KKDİK Regulation is included in the Cost Sharing Guideline Data Sharing Guideline Section 7 – Cost Sharing.
9.8 Who is responsible for pre-registration questioning and for what reason?
For unregistered substances, potential registrants should inquire whether a registration dossier for the same substance has been submitted to the Ministry prior to registration.
Article 24 of the KKDIK Regulation states that while existing vertebrate animal studies must be shared, other studies may also be shared. Therefore, potential registrants should refer as much as possible in their registration dossiers to test studies previously conducted on vertebrate animals. It is possible, but not mandatory, to refer to previously submitted dossiers for information generated by means other than tests on vertebrate animals.
In this respect, it should be kept in mind that MBDFs will continue to operate until June 1, 2018. This allows a new ‘registrant’ making an inquiry to contact an existing MBDF to facilitate data sharing.
9.9 What is the difference between an MBDF and a consortium or what are the other cooperation options under the MBDF?
MBDFs do not have a legal structure. MBDFs are a group of potential ‘registrants’, downstream users and third parties interested in the same substance (Article 25 of the KKDIK Regulation) and therefore may have data sharing obligations or data sharing opportunities under KKDIK. The KKDIK Regulation does not impose obligations on MBDF participants to form or enter into a consortium or otherwise enter into a cooperation agreement. In this way, actors’ consortium membership or other cooperation agreements are entirely voluntary, while participation in the MBDF is mandatory for the actors specified in Article 25 of the KKDIK Regulation. If some or all participants of one or more MBDFs decide to form a consortium, they are free to regulate the scope, purpose, conditions, duration of membership or leaving membership, etc., as long as it is not contrary to competition rules. In addition, if MBDF members are not part of a consortium or other agreement, consortium members are obliged to cooperate with MBDF participants (who are not part of a consortium or other agreement). More information is provided in Chapter 10 ‘Forms of Cooperation’ of the Data Sharing Guidelines.
9.10 Is a consortium necessary for the organization of activities within the MBDF?
Consortia are a more formal form of cooperation between ‘registrants’ to provide practical assistance to the data sharing obligations of the MBDF and to prepare registers. The formation of a consortium is often required for the organization of activities within the MBDF, such as data sharing and joint presentation of data. KKDIK legally requires neither a full consortium agreement nor a written agreement.
However, within the scope of KKDIK, agreements should be made between different parties on various issues such as sameness of substances, classification and labeling, data and cost sharing, ownership of joint work, selection of the leading registrant. When making agreements, the parties involved need to be careful about intellectual property rights, confidential information and competition legislation. For this reason, regardless of the type of cooperation chosen, the parties keep a record of the agreements in writing (this can be in the form of a contract or by e-mail). Detailed information on different types of cooperation within the scope of the KKDİK Regulation is provided in the Data Sharing Guide Chapter 10 ‘Forms of Cooperation’.
9.11 Is it possible to leave the MBDF?
If not, what happens if the company stops its activities related to the substance for which a preliminary MBDF registration has been made? No, this is not possible. If the MBDF member subsequently terminates its activity related to the substance, the company will still remain a participant of the MBDF. In particular, its information will need to be shared in accordance with the data sharing provisions of the KKDIK Regulation. However, participation in any presentation (or update) made by MBDF members or participation in the related additional cost is not mandatory.
If you decide to stop production during the pre-MBDF process or if you stop importing a specific substance, you can opt out of the pre-MBDF to show that you do not intend to register the substance. However, even if you are an inactive participant, you may still be required to share your data.
9.12 Do I have to be an MBDF member to register an item?
Pursuant to Article 12(1) of the KKDİK Regulation, if the substance is required to be registered by more than one manufacturer/importer, the lead registrant must submit the registration file jointly with the agreement of the other consenting registrant(s). This agreement is required under the MBDF. Therefore, all registrants of the same substance must be members of the MBDF according to Article 25 of KKDIK.
In practice, KKS lists the contact information of the companies that have pre-registered the substance with the same name or the same chemical code in the MBDF so that they can communicate with each other. Article 25 of the KKDİK Regulation states that those who pre-register the same substance in the MBDF will be MBDF participants. In addition, those who register without pre-registering before June 1, 2018 will participate in the relevant MBDF.
Information on the categories of MBDF participants and their obligations and obligations are provided in Chapter 4.2. MBDF Participants of the Data Sharing Guidelines.
9.13 I have made a preliminary MBDF registration for an item that I do not intend to register. Can I then become a member of MBDF for that item?
Yes, you will be an MBDF member. The CDS lists the contact details of companies with the same name or the same chemical identities in the pre-MBDF so that they can communicate with each other. The companies in the pre-MBDF should decide whether the substance is the same substance for which they have preliminary MBDF registration after a detailed assessment of the identity of the substance. Pre-MBDF registrants of the same substance will form an MBDF.
If you are a pre-MBDF member for an item and do not intend to register, you should unsubscribe from the pre-MBDF to indicate this to potential registrants wishing to form an MBDF to co-present.
9.14 What is the role of the Ministry in MBDF formation?
The Ministry will not participate in discussions among potential registrants and will not play a role in confirming or denying the creation of a particular MBDF.
Every potential registrant must be familiar with the identity of manufactured and imported substances. Therefore, the responsibility for correctly identifying the substance about which an MBDF is to be created lies with the manufacturer, importer and sole representative. In addition, they are free to choose how to communicate and organize themselves within the pre-MBDF.
9.15 What are the differences between the roles of the MBDF formation manager and the lead registrant?
After the preliminary MBDF registration, the role of MBDF formation manager was created to facilitate the exchange of information and data needed to create the MBDF, initiate and conduct discussions.
The company wishing to be the MBDF formation manager should have the initiative to communicate with other participants within its pre-MBDF for the purpose of MBDF formation.
While the MBDF formation manager has an important role from the pre-MBDF phase to the MBDF formation, the lead registrant plays a role in the MBDF and joint submission as stated in Article 12(1) of the KKDIK Regulation. According to the KKDIK Regulation, it should be seen that the roles of the MBDF Formation Manager and the lead registrant are very different.
While the KKDIK Regulation envisages roles for the lead registrant within the MBDF and within the scope of co-registration, there is no formal definition for the MBDF formation manager. This means that there is no requirement for potential registrants to use an MBDF formation manager during the creation of an MBDF and the MBDF formation manager can be bypassed to initiate pre-MBDF discussions. However, other registrants in the MBDF are required to select a lead registrant to submit a joint registration dossier before submitting registration dossiers on their own.
One of the major differences between the MBDF formation manager and the lead registrant is the way in which potential registrants can assume these roles. In order to become an MBDF formation manager, the potential registrant must volunteer through the PDS. In contrast, a lead registrant operates by decision/agreement of other registrants who have registered the same item. Therefore, a registrant can only become a lead registrant if it is accepted by other MBDF members. The KKDIK Regulation does not explain the rules on how the lead registrant should be selected and appointed. However, it is recommended that those who are selected as the lead registrant inform the Ministry by using the lead registrant section in KKS.
Further guidance on the duties of the MBDF formation manager is provided in the Data Sharing Guidelines 3.10-‘MBDF Formation Manager’.
9.15 What are the differences between the roles of the MBDF formation manager and the lead registrant?
After the preliminary MBDF registration, the role of MBDF formation manager was created to facilitate the exchange of information and data needed to create the MBDF, initiate and conduct discussions.
9.16 I have received a request from the MBDF Formation Manager to pay a fee. Should I comply with this request?
The tasks of the MBDF formation manager are not defined in the KKDIK Regulation. The MBDF formation manager is expected to have the initiative to communicate with other participants during the pre-MBDF to facilitate the exchange of information and data (knowledge) necessary to create an MBDF. However, the MBDF formation manager has no managerial role beyond facilitating discussions and is not legally authorized to compel other pre-MBDF participants to cooperate with him/her. As a result, the MBDF convener cannot charge for his or her services unless mutually agreed between the parties.
9.17 Since Article 26 of the KKDİK Regulation, data sharing and cost sharing rules only apply to the same MBDF, can the Ministry help the parties to resolve disputes between two different MBDFs?
According to the KKDIK Regulation, multiple registrants of the same substance are obliged to share data (and submit jointly). Therefore, if a registration contains information that has not been previously submitted by another registrant, there is no obligation for participants in different MBDFs to share data, even if encouraged by KKDIK to reduce the costs of animal testing and compliance with obligations. Each request for access to studies in different MBDFs needs to be negotiated on a case-by-case basis in different MBDFs by the relevant companies. This is not the responsibility of the Ministry.
In addition, guidance on rules (grouping, cross-reading) between MBDFs can be found in the Data Sharing Guidelines, Chapter 4.6.
9.18 How can the Ministry help with data sharing issues?
1. In the case of substances for which no preliminary MBDF registration has been made:
If the previous registrant and the potential registrant cannot reach an agreement on data sharing or costs, the potential registrant may ask the Ministry for permission to refer to the data if the potential registrant has made every effort to reach an agreement but believes that the other party has acted otherwise. In this case, the potential registrant shall inform the Ministry about the data sharing issue.
Furthermore, the two parties should continue to seek ways to reach an agreement after the issue has been raised with the Ministry.
2. In case of pre-MDF registered substances:
2.1 Where a joint registration dossier has already been submitted, and the current registrant(s) (or their representatives) have not shared the data submitted, a potential registrant who considers that it has made every effort to reach agreement may ask the Ministry to allow it to refer to the vertebrate animal studies included in the joint registration that it is required to submit.Translated with DeepL.com (free version)
2.1 Where a joint registration dossier has already been submitted, and the current registrant(s) (or their representatives) have not shared the data submitted, a potential registrant who considers that it has made every effort to reach agreement may ask the Ministry to allow it to refer to the vertebrate animal studies included in the joint registration that it is required to submit.
Furthermore, once the issue has been raised with the Ministry, the two parties should continue to seek ways to reach agreement.
2.3 In the case of a joint registration dossier in preparation that has not yet been submitted, where data gaps have been identified by participants in the MBDF but none of the potential registrants are willing to carry out the essential tests, MBDF participants requiring this information (in terms of their own tonnage band requirements) may request the Ministry to appoint one of them to carry out the missing tests.
9.19 How can I be sure that the Ministry will consider the data sharing dispute?
The Ministry will review all allegations submitted to it (FAQ 9.20).
In order to justify its claims, however, the applicant must show that it has made every effort to reach agreement on the data. This includes a clear request for information, dealing with unsatisfactory answers, resolving disputes and giving the other parties the necessary time to refer to their arguments and proposals. When submitting its justification to the Ministry, the applicant must provide all relevant support documents (such as the MBDF agreement) and explain this to the Ministry.
9.20 Do I have any obligations regarding data sharing after submitting the registration file?
After successful submission of the registration file, registrants may have tasks that may require them to share their data.
This can happen when new potential registrants join the MBDF as late pre-MBDF registrants of the substance. The same happens when, following the inquiry, the Ministry informs previous and other potential registrants of potential registrants who have not pre-registered the substance in the MBDF. The previous and potential registrants are then obliged to share the data required for registration according to Articles 26 and 30 of the KKDIK Regulation.
The obligation to share data may also arise following the successful submission of a registration dossier if new information becomes available. In such a case, according to Article 22 of the KKDIK Regulation, existing registrants updating the common registration dossier may require sharing of previous data and may have an impact on the classification and labeling decision. This may also lead to changes in the Chemical Safety Report.
Similarly, data may need to be shared as a result of the assessment of the registration dossier by the Ministry (conformity check and test offer checks) or substance assessment. These processes may require more information to be made available. Registrants should agree on the creation, sharing and cost of data. Therefore, data sharing applies not only to ‘existing’ studies but also to studies that require ensuring that the registration is compliant with the KKDIK Regulation.
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