Praktiske råd til dataudveksling og fælles indsendelse med medregistranter

The following elements must be part of the data-sharing agreement:

Data itemisation

The existing registrant must provide information on the specific data to be shared. This information must allow the potential registrant to assess the property of the data as well as the quality and reliability of the studies. Such information may include the year of the study, whether it is GLP compliant, etc.

Cost itemisation

A cost itemisation lists the costs related to data (endpoint-by-endpoint) and to administrative work. Each item needs to be justified and the costs have to relate to the information the potential registrant requires for its registration.

Note that the existing registrant cannot request the potential registrant to fulfil preconditions to obtain this cost itemisation. In particular, they cannot request the potential registrant to pay a deposit or pay any fee for that information.

In some cases, having a very detailed cost itemisation may be difficult and not helpful. In such cases, the existing registrant can discuss with the potential registrant whether they would agree not to itemise certain or all elements – potentially for a decrease of the costs.

For further information, check the Fact sheet on typical cost elements in data-sharing negotiations.

It is not always possible to precisely divide data and administrative costs. Nevertheless, all cost items should be justified so that the potential registrant is able to determine which of them relate to their information requirements.

Itemisation of data costs

Each individual study has a cost. This cost can consist of the costs for performing a test, the costs for buying access to required studies or the costs of fulfilling the information requirement with a non-testing method. Co-registrants may agree on any cost calculation method they find appropriate. For example, either historical costs or replacement costs can be used. Historical costs are based on actual invoices whereas replacement costs refer to costs for performing the test again.

Itemisation of administrative costs

Administrative costs are the costs of creating and managing the data-sharing agreement between the registrants.

Some of the administrative costs may be data-specific. For example, costs to conduct a literature search or to develop the reasoning for a data waiver clearly relate to an endpoint and not to the entire dossier.

As the potential registrant only has to pay for data that they actually need, they do not have to pay data-specific administrative costs if they relate to an endpoint which the potential registrant does not need or for which the registrant already has the relevant data.

Some of the administrative costs, however, are not data-specific, but related to general administration of the joint submission. For example, the costs of communicating among co-registrants or managing the access to the joint submission could apply to all members equally.

In any case, the existing registrant must be able to justify the costs and the way they are shared.

For further information see Annex III to the Guidance on data sharing for examples of data and administrative costs.

Cost-sharing method

The co-registrants must agree on a cost-sharing method they consider appropriate. This method must be fair, transparent and non-discriminatory.

In any case, it is important that the method used can be understood by the co-registrants.

Reimbursement scheme

Each co-registrant’s proportion of the costs depends on how many co-registrants share the data. It makes a significant difference if the costs are shared between 2 or 200 co-registrants.

Having a reimbursement scheme is mandatory and will make sure that the costs are equally shared. Each time a new potential registrant shares the data, the overall costs for each co-registrant are reduced. When and how frequently the costs are re-calculated needs to be agreed on.

Note that future registrants will have the right to ask for a reimbursement scheme even if all earlier registrants agreed not to have one.

Potential future costs

These costs relate, for example, to spontaneous dossier updates or to the generation of any future additional information requirements for the substance.

The existing registrant cannot force potential registrants to pay upfront for potential costs that they may only incur later.

However, the existing registrant must agree with the potential registrants to establish a system that covers these potential future costs. In that agreement, each registrant only needs to pay for what they need to be compliant with REACH. See more in Chapter 5.5.5 ‘New studies’ of the Guidance on data sharing for more information.


Categories Display

Mærket som:

(klik på mærket for at søge efter relevant indhold)