Drug database
Types of products for which an application for marketing authorisation for a medicinal product cannot be accepted
The State Institute for Drug Control notifies that an application for marketing authorisation of a medicinal product can only be submitted for a product that fulfils the definition of a medicinal product.
Medicinal products are defined in Section 2 of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (hereinafter referred to as the “Act on Pharmaceuticals”). In case of submission of an application for marketing authorisation of a product that does not fulfil the definition of a medicinal product, the State Institute for Drug Control (hereinafter referred to as “SÚKL”) does not assess the application and discontinues the administrative procedure. Since the nature of the product is decided at national level, it is irrelevant whether the product was or is considered to be a medicinal product in another country. In case of doubt, it is possible to ask SÚKL for an opinion or a decision on the nature of the product before submission of an application for marketing authorisation (more information is available on the SÚKL website).
Typical products that SÚKL does not consider to be medicinal products, and for which the administrative procedure for their registration as a medicinal product will be discontinued, are:
Iceland moss (Lichen islandicus): despite the published monograph (European Union herbal monograph), it is not classified as a medicinal product in the Czech Republic (no significant pharmacological, metabolic or immunological effects have been identified; it acts as a so-called demulcent, a substance that softens and soothes damaged or inflamed mucosal surfaces).
Diosmectite / Simethicone: its mechanism of action is based on a physico-chemical principle (as a sorbent) and therefore it is considered a medical device in accordance with the definition of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
Activated carbon: its mechanism of action is based on a physico-chemical principle (as a sorbent) and is therefore considered a medical device in accordance with the definition of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
Glycerin (suppositories): its mechanism of action is based on an osmotic, i.e. physical, effect and is therefore considered a medical device in accordance with the definition of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.