Amendment to the Medicines Act – safety stock

5. 1. 2024 | Articles, Medicinal preparations

When does it enter into force and what are the main changes it brings

On 29 December 2023 (the last working day of the year 2023), the Collection of Laws was published in the

Amendment to the Medicines Act introducing the so-called safety stock (No. 456/2023 Coll.),
amendment of all related decrees
- No. 458/2023 Coll. – amendment to Decree No. 329/2019 Coll. on prescribing,
- No. 459/2023 Coll. – Amendment to Decree No. 84/2008 Coll. on Good Pharmacy Practice,
- No. 460/2023 Coll. – Amendment to Decree No. 228/2008 Coll. on the Registration of Medicinal Products
- No. 461/2023 Coll. – amendment to Decree No. 229/2008 Coll. on the manufacture and distribution of pharmaceuticals
a new decree establishing a list of products not subject to the safety stock obligation.

Since when the change to the Medicines Act is effective

The change to the ZOL is effective on a split basis:

The safety stock itself as of 1 June 2024!
Other obligations, including detailed cooperation with SÚKL, changes in the notification of marketing interruptions, REG and DIS as of 1 January 2024!
The fairness of such a short preparation time can be debated for a long time, but we will feel some of the effects of this amendment in February at the latest (and many of us before that).

The full text of the amendments can be found here:

https://aplikace.mvcr.cz/sbirka-zakonu/ViewFile.aspx?type=c&id=39777

As a reminder of the basic news

an obligation for the holder to supply the market after its product has ‘run out’ for 1 or 2 more months of the average supply for the previous year if the product is reimbursed or has a maximum price (OTC products do not have this obligation)
only products that have not yet been on the market for 12 months and products listed in the Ministerial Decree are exempted from this obligation
the obligation of the holder to communicate to SÚKL, upon request, the expectation of supply (even when a competitor is threatened with an outage)
the possibility and obligation for SÚKL to label products with the symbol “Restricted availability”, by means of a measure of a general nature, which can be found on the SÚKL website
the obligation for the holder, the distributor and pharmacies to report daily stock levels of products with the symbol “Restricted Availability ” – which for distributors – the holder’s sister companies – means the obligation to report stock levels even for products that will never be in stock
a ban on the export of products labelled “Restricted Availability”
A ban on distributors favouring any pharmacy when ordering medicines, which applies to all medicines (which will have an impact on the actual operation of DTP and DTH models)
REG and DIS reports must be submitted by the 5th day of the following month and in the case of DIS, together with the identification of the recipient by the workplace code (again with implications for the normal operation of the DTP and DTH model)
the Ministry may, as of 1 January to start creating a list of products where each distributor will have to keep a reserve stock of 1 month’s supply of such product to pharmacies, the list will be created by a measure of a general nature, which can be found on the website of the Ministry of Health
The catalogue of products to be exempted from the safety stock was issued by decree and remains very narrow (for example, blood products and blood derivatives are not excluded, gene therapy is not excluded, nor are seasonal products), but may still be expanded by 1 June. The current list of products excluded from the safety stock obligation (but not from the others) is: