I. Dietary supplements
Dietary supplements are foodstuffs, which differ from foodstuffs for regular use by the high content of vitamins, minerals or other substances with nutritional or physiological effects and which have been manufactured in order to supplement regular diet of the consumer to achieve a level beneficial for his/her health. This implies that they are not indented for the treatment or prevention of diseases.
Dietary supplements are in the Czech Republic assessed and authorised by the Czech Ministry of Health. Before these products are placed on the market, the Ministry assesses their safety, which means that their long-term use should not injure people’s health.
The effects declared by the manufacturer are not verified by any other person, as the efficacy of dietary supplements is not assessed. If the declared effects of the product are not inconsistent with legal regulations governing the labelling of foodstuffs and dietary supplements, they may be stated on the labelling and other package inserts of the product regardless of their veracity.
Dietary supplements cannot, pursuant to effective legal regulations, declare preventive, therapeutic or healing properties nor refer to them. Yet statements which are at least misleading may be often seen in dietary supplements, as the manufacturers are trying to evoke the feeling that the product has preventive or therapeutic properties even if this is not stated explicitly. Most often these are statements about the therapeutic properties of individual components of the product, about evidence of its effects from clinical studies, or about its authorisation by the Ministry of Health. Statements declaring that the presented effects have been evidenced by clinical studies must be approached with caution. The manufacturer often refers to studies conducted in the concerned active substance outside living organisms, or to studies conducted in patients, yet difficult to evaluate in an unbiased manner, as the criteria governing clinical trials on medicinal products are not applied to them. Where a dietary supplement contains the same active substances as an authorised medicinal product the manufacturer unfortunately often refers to clinical studies conducted on the concerned medicinal product by which he/she deceptively “supports” the use of the dietary supplement for the labelled purpose of use. The information stating that the product has been authorised by the Ministry of Health means that the product has been assessed in terms of its safety (see above), not that the Ministry of Health of the Czech Republic has assessed or approved its efficacy or that it actually recommends to use the product.
II. Medicinal productsThe assessment and authorisation of medicinal products in the Czech Republic is within the powers of the State Institute for Drug Control (SÚKL). Unlike dietary supplements, medicinal products are, prior to their placement on the market, subjected to a marketing authorisation procedure within the scope of which the product quality, safety and efficacy for the defined therapeutic or preventive indications are evaluated. As for the evaluation of efficacy of a medicinal product, it is hereby reiterated that the efficacy must be evidenced by relevant clinical studies the conduct of which has to comply with the tight criteria established by legal regulations. The indications specified for a medicinal product are based upon the results of completed clinical studies and have to be consistent with them (i.e. for medicinal products, unlike for dietary supplements, no indications or purposes of use for which clinical studies have not been conducted may be stated). The safety of medicinal products is regularly monitored and evaluated for the entire period when the medicinal product is in circulation, both on the part of the marketing authorisation holder (who is responsible for its product) and on the part of SÚKL. If the risks implied by the use of the medicinal product happen to prevail over its therapeutic benefits, appropriate action is taken to make sure that the health of patients is not jeopardised.
III. Differences between a dietary supplement and a medicinal productBelow are specified the essential rules for the distinction between a dietary supplement and a medicinal product.
- As stipulated by legal regulations, the labelling of a dietary supplement must state “dietary supplement”.
- In some dietary supplements you can see the HEM number, which is still provided on the labelling of these products by some manufacturers. This is a reference number of the decision under which the Ministry of Health of the Czech Republic has previously authorised the placement of the product in circulation as a foodstuff.
- Pursuant to legal regulations, the labelling and package information of a medicinal product which has been granted marketing authorisation via the marketing authorisation procedure must state so called marketing authorisation number.
The structure of the marketing authorisation number depends on whether the medicinal product has been authorised only in the Czech Republic (so called national authorisation) or via so called centralised procedure where the marketing authorisation applies to all Member States of the European Union.
The marketing authorisation number for national authorisations is allocated by SÚKL and it has the following structure:
AA/BBB/XX-C (e.g. 15/062/98-C)
Where:AA – is the denomination of so called indication group under which the product has been classified (the indication group includes all medicines for the treatment of the concerned range of conditions, e.g. antibiotics, antidepressants, anaesthetics, laxatives, hormones);
BBB – is the incremental number of the marketing authorisation in the concerned calendar year;
XX – gives the last two digits of the year of marketing authorisation;
C – concerns geographic information (the country where the medicinal product has been authorised, i.e. the Czech Republic).
The marketing authorisation numbers from centralised procedures are allocated by the European Medicines Agency (EMEA) and have the following structure:
EU/A/BB/CCC/DDD (e.g. EU/1/08/123/007)
Where: EU – means that it is a product authorised via the centralised procedure;
A – stands for the nature of the medicinal product (product for human or veterinary use or an orphan product);
BB – gives the last two digits of the year of marketing authorisation;
CCC – is the sequence number of the marketing authorisation in the concerned calendar year;
DDD – expresses the presentation number of the medicinal product.
4. SÚKL website provides a database of authorised medicinal products where it is possible to search by the name of the product, by the active substance, ATC group or SÚKL code. In case of doubts concerning the type of product it is possible to find out from the database whether the product is an authorised medicinal product or not.