Notice to sponsor/applicant submitting amendment /new data/ change to pharmaceutical documentation for active (ongoing) clinical trials

In compliance with Section 16, paragraph 1 of Decree No 226/2008 Coll., on the good clinical practice and more detailed conditions for clinical trials on medicinal products, major changes to a clinical trial subjected to notification to SÚKL shall now include also the following: changes to investigational medicinal products (IMPD) affecting their quality, e.g. changes in composition, manufacturing process, specifications of storage conditions, and expiry dates. These notified changes are subjected to cost reimbursement; the proof of payment is to be submitted together with the notified changes.

Important notices:

1)  The box "Specification of application" in the Proof of payment of costs incurred by  expert activities performed upon request ("tax receipt") should always be completed with the identification of the clinical trial (i.e. EudraCT number, protocol number, SÚKL ref. no., etc.) as well as with the information about the subject of cost reimbursement (i.e. for example Amendment no. 3 to the Protocol, supplement to pharmaceutical documentation, stability data, etc.).  Please make sure that the payment order includes the generated variable symbol.  Particularly for foreign payment of costs it is necessary for the payment order to include the variable symbol always also in the message for payee/recipient!!! (This requirement ensures that it will be possible to identify the payment of costs, as some foreign banks do not state the variable symbol!).

2) If an Amendment to Protocol subjected to cost reimbursement and changes to pharmaceutical documentation subjected to cost reimbursement or more Amendments to protocol are submitted at one time, it is necessary to reimburse the costs of every document, i.e. for each Amendment to the Protocol and for each change to the pharmaceutical documentation. It is recommended to make each payment separately/individually, always with a different variable symbol, and explain in the "Specification of application" box what the payment has been made for. It is also possible to make one joint payment under a single variable symbol, but in this case it is also essential for the "Specification of application" box to provide a list of all documents covered by the payment (e.g. Amendment No. 2 + supplement to pharmaceutical documentation).

3) If at one time a single supplement to pharmaceutical documentation is submitted which is related to more than one clinical trial, it is subjected to one reimbursement of costs. In the "Specification of application" box of the Proof of payment of costs incurred by expert activities performed upon request (Tax receipt) it is necessary to specify the identification of all clinical trials which  relates to (all EudraCT numbers, Protocol numbers or SUKL ref. numbers) and the identification of activities covered by the payment, e.g. a supplement to pharmaceutical documentation.