State Institute for Drug Control

The Regulation no. 228/2008 Coll., Section 2 (j) obliges STP submitters to monitor and evaluate safety and efficiency of the medicine; the method of performing the above is up to the submitter. An application for STP includes the plan of STP monitoring control proposed by the STP submitter, including the person responsible for STP monitoring. The report on the progress of STP will include information about the number of patients included in the program, assessment of occurrence of all adversary effects, and information about the number of packages used, which will also be included in the statement of SUKL for the STP.

If a STP has been approved while the maximum price and payment has not been determined, another payment method shall be required (it may be paid for from public health funds only upon decision of a medical officer, even if a STP has been approved, but the maximum price and payment have not been determined). In the meantime, the medicine may be paid for by the submitter, the patient, or the healthcare facility.

The Department of Prices and Payments of SUKL is in charge of this agenda. Determination of payment takes 75 days, while determination of price AND payment takes 165 days.

The submitter of STP is responsible for and provides for labelling of the medicine. Additional labelling of the package with “Přípravek je používán v rámci specifického léčebného programu“ (For the purposes of a specific therapeutic program) may be done by the manufacturer.

No, if a medicine has been registered, it may not comply with the conditions of STP (i.e. the condition that a medicine may not be registered); the submitter of STP should notify the Ministry of Health of ČR and SUKL of this new fact and terminate STP; STP may also be terminated by the submitter. After termination of STP, the submitter should also provide for withdrawing of the medicine from pharmacies and distributors.

No, a medicine of a STP specific treatment program may only be used in accordance with the Decision on Approval of a STP by the Ministry of Health of the Czech Republic, i.e. the conditions of the indication, the designated population, and specific healthcare facilities that may use a STP medicine must be complied with.

No. Any changes would have to be approved – e.g. a new worksite, a higher number of patients, another distributor, a new diagnosis. As an application is processed by the Ministry of Health of ČR by opening and executing an administrative procedure, the Ministry does not intervene in the STP anymore after a decision has been issued. In some cases, the above changes may be requested by means of a new STP.

Yes, stating the information that the medicine is unregistered also applies to specific therapeutic programs, within which they also represent unregistered medicines.

No, pursuant to Section 85 (1) of the Act no. 378/2007 Coll., the subject of mail order may only include medicines registered pursuant to Section 25 (1), the dispensing of which does not require a prescription under the registration decision.

Pursuant to Section 103 (5) (b), this is an offence with the maximum imposable penalty of CZK 100,000.

The pharmacovigilance system (collection, evaluation, and reporting of adverse reactions) should be set out by the applicant in the specific therapeutic programme (hereinafter referred to as “STP”) plan.

If the applicant is a marketing authorization holder for the product in another EU country, then it follows the GVP Module VI - reports from SpTP are so-called solicited reports (study reports). Reports are sent electronically by the applicant / holder directly to the EudraVigilance database in the standard time mode: serious within 15 days, non-serious within 90 days.

If the applicant is an entity that is not registered in the EudraVigilance system, the AR reporting takes place via State Institute for Drug Control (hereinafter “Institute”). The following system is recommended:

The person responsible for monitoring SpTP reports serious or unexpected adverse reactions within 15 days, non-serious within 90 days.

Report form:

1. by filling the CIOMS form and sending it by e-mail to farmakovigilance@suklcz or by post, or
2. via the electronic web form for reporting the adverse reactions (hereinafter “AR”) to Institute.

In the electronic form as well as in the CIOMS form, it is necessary to state "medicine in STP" in the note.

If the applicant is an entity registered in the EudraVigilance system but does not hold a product with the same active substance as that in the STP, as a registered user of EudraVigilance, it reports electronically directly to the EudraVigilance database or use the reporting system via Institute, see above, both alternatives are possible.

We remind you that this concerns the adverse drug reactions reporting only - ie the reporter suspects a possible causal link between the administered suspect product and the adverse reaction. Adverse events from STP are not reported to Institute. The applicant records and evaluates them within the Interim / Final Report.

In the event of death or threat of the patient's life while using the product within the STP it is (apart from the actual reporting to EudraVigilance or Institute) necessary to inform Institute immediately by e-mail to farmakovigilance@suklcz within 7 calendar days.

Physicians, pharmacists, and other healthcare professionals are obliged to report suspicions of serious or unexpected side effects or other facts related to the use of a medicinal product, which they also encountered within the STP, immediately to the Institute pursuant to Section 93b of the Pharmaceuticals Act.