State Institute for Drug Control

No, pursuant to Section 85, paragraph 1 of Act No 378/2007 Coll., only medicinal products authorised in compliance with Section 25, paragraph 1 the dispensing of which is not, pursuant to the marketing authorisation, subject to medical prescription may be subject to mail-order dispensing.

Decree No 228/2008 Coll. Section 2, letter j) requires the specific therapeutic programme proponent  to monitor and evaluate the product safety and efficacy; the proponent may choose how he complies with this requirement. An application for specific therapeutic programme includes also a schedule of the specific therapeutic programme monitoring control, which is proposed by the specific therapeutic programme proponent, including the person responsible for the monitoring of the specific therapeutic programme. In the specific therapeutic programme progress report, it is then required to submit information on the number of patients included in the programme, the evaluation of all adverse reactions and on the number of used packages, which is also stated in SÚKL’s opinion on the specific therapeutic programme.

If the specific therapeutic programme has been approved and the medicinal product does not have any determined maximum price and reimbursement, another reimbursement method has to be employed (reimbursement from public health resources shall be possible only after a decision by the auditing doctor, even if the specific therapeutic programme has been approved, but for the time being does not have any determined maximum price and reimbursement). In this period the product may be paid by the proponent, patient or the healthcare facility.

SÚKL’s Department of Prices and Reimbursements is in charge of these activities. The determination of reimbursement takes 75 days, the determination of the price and the reimbursement simultaneously takes 165 days.

The labelling of the product falls under the responsibility of the specific therapeutic programme proponent, who shall also organise it. Additional labelling of the pack with the label “For specific therapeutic programme purposes” may be performed by the manufacturer or by the pharmacy.

No, when a medicinal product  is authorised the conditions of the specific therapeutic programme are no longer met (i.e. the condition stipulating that the product cannot be authorised); the proponent of the specific therapeutic programme should report this new fact to the Ministry of Health of the Czech Republic and to SÚKL and terminate the specific therapeutic programme; a specific therapeutic programme may be terminated by the proponent as well. Following the termination of the specific therapeutic programme, the proponent should also arrange for the recall of the medicinal product from pharmacies and from distributors.

No, a product from a specific therapeutic programme may be used only in compliance with the Decision on the approval of a specific therapeutic programme issued by the Ministry of Health of the Czech Republic, i.e. the conditions governing the indication, defined population as well as the specific sites which may use the product from the specific therapeutic programme have to be observed.

The system of pharmacovigilance reporting –should be determined by the specific therapeutic programme proponent in the plan. The following system is recommended: To forthwith report serious unexpected adverse drug reactions = SUADR (within 7 days where a death or life-threatening reaction is involved +8 days for the supplementation of the report; other SUADRs within 15 days); to record and send unexpected ADRs and serious expected reactions ADRs within the scope of the Progress report. The reporting duty lies with the person responsible for the monitoring of the specific therapeutic programme.

Reporting methods:

1. By completing the CIOMS form and its sending, either by post or by mail (klinsekret@suklcz  or tomas.boran@suklcz); or
2. By completing the electronic form; it is necessary to insert the following information in the remark: – “product in a specific therapeutic programme”.

No, it is not. Any change would have to be approved – e.g. a new worksite, more patients, another distributor, new diagnosis. With a view to the fact that the Ministry of Health of the Czech Republic  handles the application by means of starting and conducting an administrative procedure, once the decision is issued, they no longer interfere with the concerned specific therapeutic programme. Sometimes it is possible to apply for the above-mentioned changes by means of a new specific therapeutic programme.

Yes, mentioning the fact that a non-authorised medicinal product is concerned applies also to specific therapeutic programmes as they also involve non-authorised medicinal products.

Pursuant to Section 103, paragraph 5 (b), this constitutes an offence which may be penalised by imposing a fine of up to 100,000 CZK.