- Medicinal products for human use and transmission of data from marketing authorisation holders

Draft implementing decree amending Implementing Decree No 228/2008 on
the marketing authorisation of medicinal products, as amended

This is a draft amendment to Implementing Decree No 228/2008 on the marketing authorisation of medicinal products, as amended.

The aim is to ensure the transmission of data to assess the
availability of medicinal products on the Czech market, thus making it
possible to gain an overview of which and what quantity of medicinal
products for human use are available on the market in the Czech
Republic. The information obtained from marketing authorisation holders
will be used to make an up-to-date assessment of the availability of
each medicinal product, which will enable the Ministry of Health to draw
up a list of medicinal products at risk of becoming unavailable in
accordance with § 11(q) of the Pharmaceuticals Act and, if appropriate,
take regulatory measures in accordance with § 11(g) of said Act.

The draft implementing decree also responds to experience gained while applying the legislation.

Keywords: medicinal products for human use, availability of medicinal products on the market, transmission of information