On 16 October 2019, the Slovak Parliament adopted Act No. 383/2019 (Amendment), amending numerous essential provisions of Act No. 362/2011 on Medicinal Products and Medical Devices. The most important changes are described below.
Re-export of medicinal products
In reaction to the most common cases of circumvention of the specific Slovak law restricting re-export, the Amendment is introducing stricter conditions to parallel trade of reimbursed medicinal products:
- Save for the marketing authorisation holder (MAH) and the wholesaler authorised through a power of attorney by the MAH, only the manufacturing authorisation holder who manufactured the medicinal product shall be authorised to export a reimbursed medicinal product, which shall not include a manufacturing authorisation holder performing only partial manufacturing activities related to division, packing and adjustment of packaging of the product;
- The pharmacies shall be entitled to sell to other pharmacies only less than five packages of reimbursed medicinal products or medicinal product with officially determined price with the same SIDC code in the same calendar month (at the same time, the restriction on resale of medicinal products between pharmacies for the period of three-month from the supply of the product from the wholesaler has been revoked). Supply of medicinal product to a wholesaler, or to a pharmacy in another EU Member State, and supply of more than five packages of a reimbursed medicinal product or a medicinal product with an officially determined price, with the same SIDC code per calendar month, shall not be possible based on pharmacy authorisation;
- Pharmacies shall be obliged to make available (i) the evidence and records of purchase, dispensation, and supply of reimbursed medicinal products and medicinal products with an officially determined price upon request to the authorities, and (ii) the evidence and records of receipt, supply, re-sale, and return of reimbursed medicinal products to the Ministry of Health in an electronic form, within five days;
- Pharmacies shall be prohibited from entering into warehousing agreements for reimbursed medicinal products or medicinal products with an officially determined price, save for medicinal products centrally purchased by a health insurance company, while the reimbursed medicinal products and medicinal products with an officially determined price need to be stored directly in the premises stated on the pharmacy authorisation.
New pharmacovigilance obligations
The scope of pharmacovigilance obligations of the MAH is being extended to new mandatory notifications to the SIDC and new obligations, formulated relatively broadly, affecting also circumstances abroad:
- Notification of every withdrawal of a medicinal product for human use from the market required by a competent authority of an EU Member State or a third country, or performed voluntarily;
- Notification of every written complaint for qualitative defects of an authorised medicinal product posing a serious risk to human health, no later than on the day following the day of receipt of the complaint;
- Notification of the results of own investigation following a complaint reported to the SIDC.
Medical devices
The Amendment is consolidating the local legal regulations of medical devices due following the adoption of Regulation (EU) 2017/745 on medical devices. The regulation of in vitro diagnostic medical devices shall be introduced by a separate amendment.
Beyond the scope of the regulations, the conditions of clinical trials of medical devices, including the involvement of ethics committees, are being amended. The fees for the authorisation of clinical trials of medical devices are being increased, and new related fees are being introduced.
Other changes
The Amendment is introducing numerous partial changes in further areas:
- The conditions of performance of post-authorisation safety studies of medicinal products (PASS) are changing. The study protocol shall be submitted to the Pharmacovigilance Risk Assessment Committee of European Medicines Agency, should the study be performed in more EU Member States, and to the SIDC, should the study be performed only in Slovakia, based on the request of SIDC as a condition of registration of the product, or upon initiative of the MAH;
- A prescribing physician shall be prohibited from requiring a patient to register on a third-party website before prescribing a medicinal product, medical device, or a dietetic food. A health insurance company shall be prohibited from determining in which pharmacy should a patient pick up a prescribed medicinal product, medical device, or a dietetic food, save for those centrally purchased by a health insurance company;
- The obligation to perform emergency pharmacy service, and conditions of internet dispensing of medicinal products, are being amended.
The Amendment shall in general enter into force on 1 January 2020. The provisions related to medical devices shall enter into force on 26 May 2020, when the Regulation on medical devices shall enter into force. The clinical trials, and the proceedings on authorisation of a clinical trial of a medical device, initiated before, shall be concluded according to the legal regulation in force before 26 May 2020, respectively.
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This legal update has been prepared in December 2019 solely for the purpose of general information and shall not be considered a legal advice. The information above is not comprehensive and the legal update only briefly outlines the respective legislative changes. In case you are interested in further information on the above legislative changes, do not hesitate to approach your contact person in Čechová & Partners.