2018/0283/CZ
EC/EFTA
CZ République Tchèque
  • C10P - Produits pharmaceutiques
2018-09-20
2018-06-26

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

Draft implementing decree amending Implementing Decree No 229/2008 on the production and distribution of pharmaceuticals

Draft amendment to Implementing Decree No 229/2008 on the production and distribution of pharmaceuticals.

The draft amendment to the implementing decree incorporates European legislation

- concerning the issue of measures against the penetration of counterfeit medicinal products into the legitimate distribution chain,

- European Commission Guidelines of 5 November 2013 on Good Distribution Practice,

- European Commission Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use

- the most recent Compilation of Community Procedures on Inspection and Exchange of Information.

In terms of national provisions, the draft sets the ground for up-to-date assessments of the availability of each medicinal product and the preparation of reliable supporting data, 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 the Pharmaceuticals Act.

The aim is to ensure the transmission of data needed 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.

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