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.