DIS-13 version 8
Reporting Deliveries and Stocks of Distributed Medicinal Products for Human Use
This guideline supersedes guideline DIS-13 version 7.1 as of 19 January 2024
The guideline is issued on the basis of Section 77(1)(f) of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended (hereinafter referred to as the “Act on Pharmaceuticals”) and it specifies the procedures to be employed when submitting correct and complete electronic reports on the volume of deliveries and stocks of distributed medicinal products.
The guideline is of a recommendatory nature.
One of the main goals of the State Institute for Drug Control (hereinafter referred to as the “Institute”) in the area of drug policy is to safeguard effective, safe, and quality pharmaceuticals. Due to the need for state administration to work with up-to-date, correct, and complete data allowing to gain an overall picture of the availability of human medicinal products and foods for special medical purposes (with allocated SÚKL code) in the distribution chain and the fulfilment of tasks imposed upon the Institute by the Act on Pharmaceuticals, the Institute, as a technical aid and means providing for reporting uniformity, publishes recommended procedures for the fulfilment of the obligation imposed upon distributors by Section 77(1)(f) of the Act on Pharmaceuticals.
The scope of data which distributors are obliged to provide to the Institute is implied by Section 77(1)(f) of the Act on Pharmaceuticals, as amended, with effect as of 01 January 2024. The structure of the data, the form, method, and time intervals of their provision via the electronic report are set forth by Section 35b and Section 35e of Decree No 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended (hereinafter referred to as “Decree No 229/2008 Coll.”) with effect from 01 January 2024 – see https://aplikace.mvcr.cz/sbirka-zakonu/.
Timely access to and availability of information on a medicinal product, on the supplier and its client, including chronological data on the product distribution, form a necessary precondition for the product traceability within the distribution chain and an essential prerequisite for adoption of efficient and effective actions to be taken by the Institute in case the lives or health of people are jeopardised, particularly where serious adverse reactions to the medicinal product or a quality defect thereof is identified, as well as for adoption of actions of the Ministry of Health of the Czech Republic to ensure the product availability for the needs of patients in the Czech Republic.
Deliveries of foods for special medical purposes to pharmacies, healthcare facilities, and to other distributors shall be reported in compliance with the decision-making powers of the Institute in the sphere of determination of maximum prices and reimbursements of medicinal products and foods for special medical purposes as referred to under Act No 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended (hereinafter referred to as the “Public Health Insurance Act”). In compliance with the effective Price Regulation of the Czech Ministry of Health, the report shall be applicable to deliveries of foods for special medical purposes with an allocated SÚKL code only. Foods for special medical purposes without an allocated SÚKL code are not the subject of reporting. In case of failure to report deliveries of foods for special medical purposes, the foods could be considered untraded, which could, pursuant to the provision of Section 39j of the Public Health Insurance Act, result in cancellation of the price and reimbursement.
The obligation set forth under Section 77(1)(f) of the Act is to always provide complete and accurate data in the report within the scope stipulated by the Act on Pharmaceuticals and the implementing regulation. A functional system for the submission of reports forms part of Good Distribution Practice and it is subjected to regular inspections by the Institute’s inspectors. Failure to provide the data on distributed medicinal products is classified as an offence, the merits of which are defined in Section 105(2)(i) of the Act on Pharmaceuticals. Failure to comply with the obligation imposed upon distributors by Section 77(1)(f) of the Act on Pharmaceuticals may be penalised by a fine in the amount of up to 5,000,000 CZK.