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Documentation to be submitted by the applicant for SÚKL opinion

The State institute for Drug Control publishes more detail information to the submitted documentation for applicants of Specific Therapeutic Programme (hereinafter “STP”).  

  1. Application form (guideline UST-20) for the issuance of an opinion on proposed Specific Therapeutic Programme.
  2. The plan of the Specific Therapeutic Programme is a mandatory attached to the application, in case that the medicinal product is not authorized in any country it 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. In case that the medicinal product is authorized in another country, the plan is based on the Summary of Product Characteristics. The plan of STP defines the target group of patients, therapeutic indications, restriction on inclusion to the STP, information about posology and method of administration and the STP duration.
  3. 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.
  4. 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 case, this section of documentation shall also include 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. In the translation declaration is necessary to indicate the deviation from the original, e.g., the reporting of adverse reaction.
  5. Pharmaceutical documentation for the product in the extent suitable for a Clinical Trial Application. The current version of SÚKL guideline KLH-19 gives further details on the range and extent of the required pharmaceutical documentation, while the current version of SÚKL guideline KLH-12 specifies Good Manufacturing Practice requirements. Both guidelines are available on the Institute’s webpage. It is not necessary to submit pharmaceutical documentation for products authorised in the EU/EEA or countries that have signed a Mutual Recognition Agreement with the European Union, provided that the submission package of the proposed Specific Therapeutic Programme includes the Summary of Product Characteristics or equivalent information intended for healthcare professionals approved by the competent authority of the country in which the product is authorised. In exceptional circumstances, pharmaceutical documentation of products authorised in a third country may be substituted by a batch release record compliant with the marketing authorisation documentation, in line with § 62 paragraph 1 of the Act on Pharmaceuticals.
  6. Reporting of selected drug products and batch release onto the market. Medicinal products placed on the market within an STP belonging to any of the groups listed in the current version of SÚKL guideline UST-21, are also subject to mandatory reporting. Obligations defined under § 102 of the Act on Pharmaceuticals are in this case the responsibility of the Applicant.
  7. 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). In case that the medicinal product is authorized in another country, it is possible to submit a Czech translation of Package leaflet approved by the competent authority of the country in which the medicinal product is registered. Again, it is necessary to declare that the Czech translation corresponds to the original text with indication of the deviations.
  8. Proof of payment for the costs (pursuant to guideline UST-29). Information on the amounts of reimbursement and payment methods are provided in the section Pricelist and fees. Please generate a payment using an Interactive form for application related to covering expenditures for expert activities conducted upon request and administrative fees, payment code K-005.

Updated November 26th, 2021