Specific Therapeutic Programmes (hereinafter referred to as “therapeutic programmes”) pursuant to Section 49 of Act No 378/2007 on Pharmaceuticals allow for the:
- distribution, and
of human medicinal products without marketing authorisation pursuant to this Act, if the following conditions are met:
- unavailability of an authorised medicinal product or another exceptional need for the programme;
- the product is intended for conditions severely affecting human health (their treatment, prevention or diagnosis);
- the Ministry of Health has, with a view to the opinion issued by SÚKL, issued its written approval of the conduct of the programme;
- the use of the product is in compliance with the approved therapeutic programme designed in advance.
Submitter of the Specific Therapeutic Programme
- Legal or natural person;
- Submits (in compliance with the particulars stipulated by legal regulations and guidelines of the Institute) the design of the therapeutic programme to the Ministry of Health of the Czech Republic to issue its approval and to SÚKL to issue its opinion;
- Is responsible for the conduct of the therapeutic programme, if approved, and for cooperation with the Ministry of health of the Czech Republic and SÚKL.
Documentation to be submitted by the applicant for SÚKL opinion
- Application form (guideline UST-20) for the issuance of an opinion on proposed Specific Therapeutic Programme.
- The plan of the Specific Therapeutic Programme shall be submitted in the structure corresponding to a clinical trial protocol, in the Czech language, in one copy, and shall not exceed 10 pages.
- The justification of the programme, in particular explanation of the grounds for the proposed therapeutic programme, i.e. whether the subject matter is treatment, prevention or diagnosis of a rare disease, whether for the specified purpose there is not any authorised human medicinal product available, or whether another exceptional need is concerned, and whether conditions severely jeopardising human health are concerned. A condition severely jeopardising human health shall mean a condition which may be fatal, jeopardise one's life, requires hospitalisation or extension of existing hospitalisation, may result in persistent or significant disability or incapacity. In this section of the documentation it is not necessary to evidence the scientific grounds for the administration of the product, which is the subject matter of the below mentioned preclinical and clinical data. The justification of the programme may be submitted separately or as part of the plan of the therapeutic programme.
- Preclinical and clinical data in the scope adequate to the Investigator's Brochure submitted as part of the application for clinical trial authorisation; where products authorised abroad are concerned, it is possible to substitute this data with the Czech version of the Summary of the Product Characteristics or other summary information for healthcare professionals approved by the concerned authority of the country where the product has been authorised. In such a case, this section of documentation shall include also the statement of the applicant that the Czech translation fully corresponds to the text approved by the concerned authority of the country where the product has been authorised.
- Pharmaceutical data on the medicinal product to be used within the scope adequate to the pharmaceutical data submitted with an application for clinical trial authorisation or notification; where products authorised abroad are concerned, it is possible to substitute this data with the submission of product specification required for its release for use and TSE and virological safety declaration. If the programme is implemented, SÚKL will subsequently request an evidence of batch release certificates for individual batches of the product in the country of the manufacturer prior to the start of use. Where a product authorised in any EU Member State or a country of the European Economic Area, if applicable, is concerned, pharmaceutical data shall not be submitted, if the content of the therapeutic programme design includes the Summary of Product Characteristics, or other summary information for healthcare professionals approved by the concerned authority of the country where the product has been authorised. More details concerning the pharmaceutical documentation to be submitted are stipulated by guideline KLH-19, which is available from the website of the Institute.
- Information for patients in the Czech language in a reasonable scope adequate to the information intended for clinical trial subjects (Annex 2 to Decree No 472/2000 Coll. – on clinical trials on medicinal products refers), or package leaflet (Annex 3 of Decree No 476/2000 Coll. – on marketing authorisation of medicinal products refers).
- Proof of payment for the costs (pursuant to Section 65 of the Act). Information on the amounts of reimbursement and payment methods are provided in the section Pricelist and fees.
- The approved therapeutic programmes are published also in the information media of the Czech Ministry of Health, incl. its website at www.mzcr.cz.
- The Czech Ministry of Health and SÚKL control the conduct of approved therapeutic programmes and, where new facts about the medicinal products arise or in the event of a serious breach of the conditions established by the therapeutic programme, the Ministry of Health of the Czech Republic is entitled to revoke its approval; SÚKL shall suspend the use of the medicinal product where new facts arise or in the case of a serious breach of the conditions of the product use, distribution or supply established by the therapeutic programme.
- Doctors using a product without marketing authorisation within the scope of an approved Specific Therapeutic Programme shall not be subjected to the statutory notification duty to inform SÚKL of the use of a product without marketing authorisation (as opposed to the use of a product without marketing authorisation pursuant to Section 5a of the Act).
- Doctors, pharmacists or other healthcare professional who observe a suspected serious or unexpected adverse reaction or other facts relevant to health, shall be subject to the duty to notify SÚKL as stipulated by Section 90 of the Act on Pharmaceuticals.
- The amendment of the Act does not prejudice the effect of exceptions permitted in the past for the use of medicinal products without marketing authorisation which will expire upon the expiration of the period for which they have been issued.