An extensive amendment to the Act no. 362/2011 Coll. on medicines and medical devices entered into force on 1 January 2022. The amendment also implemented the EU Regulation 2017/746 on in vitro diagnostic medical devices and EU Regulation 2019/6 on veterinary medicinal products.
Below is a brief summary of the 5 key changes that pharmaceutical companies should consider. Other major changes concern, for instance:
new rules on the prescription and dispensing of medicines, dietetic food and medical devices,
authorization for the use of unregistered medicines or authorized medicines for an indication other than the one specified in the marketing authorization,
rules on delegated prescription between the general practitioner as a prescribing physician and a specialist physician,
extension of the state’s liability for damage caused by the administration of a coronavirus vaccine,
simplification of reporting to the database of veterinary medicinal products,
conditions under which the health insurance company claims compensation for the benefit it has provided to the provider of pharmaceutical care towards the doctor,
obligations of the manufacturer, importer and distributor regarding information attached to the in vitro medical device available to the user or patient in Slovak market.
1. Restrictions on re-exporting medicines
A licensed wholesaler of a medicinal product who has obtained a categorized medicinal product from another licensed wholesaler may supply that medicinal product only to a pharmaceutical care provider. However, this does not apply if a wholesaler obtained the categorized medicinal product from a wholesaler who is also a manufacturer, a marketing authorization holder (MA holder), an authorized representative of a manufacturer, MA holder, or a parallel importer of this supplied medicinal product.
2. Restrictions on warehouse storage of categorized medicines
Categorized medicines may only be stored by the wholesaler at the places specified in the wholesale licence. Also, the wholesaler shall not store medicines owned by a holder of the pharmaceutical care licence. The wholesaler is entitled to store the medicinal products owned by the pharmaceutical care provider exclusively within the exercise of the lien.
The restrictions mentioned above will prevent the re-export of categorized medicinal products and the execution of contracts between pharmacies and wholesalers for the storage of medicinal products at the wholesaler's premises, which are supplied to the pharmacy.
3. Medicines for rare diseases
Medicines for human use for which fewer than 1000 packs per calendar year are consumed are considered medicines for rare diseases. In order to increase the availability of such medicines, the amendment simplifies the requirements for placing these medicines on the Slovak market and establishes that medicines for rare diseases can be sold in foreign language packs.
The manufacturer of a medicine for a rare disease will not be required to affix a sticker with the information in the Slovak language. However, the MA holder must notify State Institute for Drug Control (in Slovak: ŠÚKL) of each delivery of the medicine in a foreign language package and provide written information about the medicine to the patient in Slovak.
4. New Ethics Committee of the Slovak Ministry of Health
The amendment establishes the Ethics Committee for clinical trials of medicines, medical devices and performance studies for in vitro diagnostic medical devices, whose main task is to oversee the protection of rights, safety and dignity of clinical trial participants. If the committee disagrees with the approval of a clinical trial of a medicine, medical device or in vitro diagnostic medical device performance study, ŠÚKL will not allow the trial.
5. Authorization of unregistered medicinal products for therapeutic uses
Until now, the Slovak Ministry of Health has authorized both the use of an unregistered (within Slovakia / EU) medicine and the use of a registered medicine for a group of medicines – for a therapeutic indication not listed in the marketing authorization. According to the amendment, unregistered medicinal products for therapeutic uses will not require approval from the Slovak Ministry of Health.