Draft amendment to Implementing Decree No 84/2008 on good pharmacy practice, detailed conditions for handling pharmaceuticals in pharmacies, healthcare establishments and by other operators and on establishments dispensing medicinal products, as amended by Implementing Decree No 254/2013

The draft implements the amended wording of § 82(3)(d) of the Pharmaceuticals Act, which was amended by Act No 66/2017, and responds to experience gained while applying the implementing decree.

The aim is to ensure the assessment of data relating to 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 operators authorised to dispense medicinal products 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.

By obtaining more comprehensive data, it will be possible to determine more accurately, compared to the current situation, the potential risk of unavailability of a medicinal product and take more effective measures to prevent the unavailability of these medicinal products to patients in the Czech Republic.

The electronic form of reporting is necessary with a view to the quantity and processing of the data obtained from the reports.

In addition, the draft includes proposals for changes resulting from the performance of surveillance in this field and providing for more effective application of the rules of good pharmacy practice in the preparation of medicinal products.

The draft amendment also incorporates legislative, technical and linguistic adaptations responding to experience gained while applying the legislation intended to contribute to greater clarity and comprehensibility of the text of the implementing decree.

Keywords: medicinal products for human use, availability of medicinal products, pharmacy practice