Act No. 362/ 2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts is one of the central legal regulations of the Slovak Republic dealing primarily with the conditions for handling medicines and medical devices, as well as requirements for ensuring the quality of medicines and medical devices. An amendment to this Act entered into force on January 1, 2020, specifically Act No. 383/2019 Coll., amending Act No. 362/2011 Coll. on Medicines and Medical Devices and on the Amendment of Certain Acts, as amended, and amending certain acts.
One of the main objectives of the legislature in adopting the amendment to the Act on Medicines and Medical Devices was, among other things, to prevent the re-export of human medicines outside the territory of the Slovak Republic and, at the same time, to establish clearer rules for the handling of medicines, failure to comply with which is punishable by the legislature with heavy fines that could be ruinous for a specific holder. The amendment to the Act on Medicines and Medical Devices introduced several significant changes in the area of handling medicines. We provide an overview of the most significant changes in this article:
- Broader Scope of Authority for the Professional Representative
- A professional representative is a natural person responsible for the professional performance of activities. Until December 31, 2019, a professional representative was authorized to perform the duties of a professional representative at only one place of business (e.g., only with one holder of a wholesale distribution license for medicinal products with whom they were employed). Thus, until December 31, 2019, a professional representative was not authorized to perform the duties of a professional representative at multiple places of business.
- The amendment to the Act on Medicines and Medical Devices clarified (expanded) the scope of practice for professional representatives. As of January 1, 2020, a professional representative is authorized to perform their duties at multiple places of practice, except for the provision of pharmaceutical care in a public pharmacy or a branch of a public pharmacy. In the case of providing pharmaceutical care in a public pharmacy or a branch of a public pharmacy, a professional representative is authorized to perform their professional activities at only one place of business.
- Prohibition on the export of categorized medicinal products for a holder of a medicinal product manufacturing authorization engaged only in partial manufacturing of medicinal products
- A holder of a drug manufacturing license, a drug registration holder, and a holder of a drug wholesale distribution license—provided they were authorized in writing by the registration holder of the drug in question to export a human categorized drug—were authorized to export a human drug listed in the list of categorized drugs from the territory of the Slovak Republic. Until December 31, 2019, a holder of a manufacturing authorization who carried out only so-called partial manufacturing—i.e., only manufacturing processes related to the division, packaging, and repackaging of medicinal products, as the previous legislation only referred to the term “holder of a manufacturing authorization.”
- As of January 1, 2020, a change has taken effect, as a holder of a manufacturing authorization who performs only partial manufacturing (manufacturing processes related to the division, packaging, and repackaging of medicinal products) will no longer be authorized, as of January 1, 2020, to export a medicinal product for human use listed in the list of categorized medicinal products outside the territory of the Slovak Republic.
- Otherwise, they commit another administrative offense in the field of human pharmacy, for which they face a fine of up to 1,000,000 euros.
- The amendment to the Act on Medicines and Medical Devices has thus tightened the conditions for the re-export of categorized medicines, as is also evident from the explanatory memorandum to Act No. 383/2019 Coll. and the legislature’s intention to reserve medicines exclusively for Slovak patients.
- Regulation of activities falling under the provision of pharmacy care
- Until December 31, 12.2019, was authorized to sell human medicines included in the list of categorized medicines to another holder of a license to provide pharmaceutical care in a public pharmacy or hospital pharmacy for the purpose of dispensing them in a public pharmacy or hospital pharmacy. Such a holder was also authorized, under the issued license to provide pharmaceutical care, to resell categorized medicines and medicines included in the list of medicines with an officially determined price to the holder of a license for wholesale distribution of medicines who supplied them to the holder.
- The amendment to the Act on Medicines and Medical Devices clarified the possibility of selling human categorized medicines and medicines included in the list of medicines with an officially determined price among holders of a license to provide pharmaceutical care in a public pharmacy or a hospital pharmacy such that that a holder of a license to provide pharmaceutical care is authorized to sell such medicines to another holder of a license to provide pharmaceutical care in a public pharmacy or hospital pharmacy in quantities of fewer than 5 packages of a human medicine with the same medicine code assigned by ŠUKL per calendar month. In the event of non-compliance with even one of the above conditions, such a holder commits another administrative offense in the field of human pharmacy, which is subject to a fine of up to 100,000 euros.
- Storage of categorized human medicines and medicines included in the list of medicines with an officially determined price on pharmacy premises
- As of January 1, 2020, the holder of a license to provide pharmacy care is required to store categorized medicines and medicines included in the list of medicines with an officially determined price only on the premises for which the license was issued as the place of business until their dispensing. If medicines are stored at another location, the holder of a license to provide pharmaceutical care commits another administrative offense in the field of human pharmacy, which is punishable by a fine of up to 100,000 euros.
- Likewise, the amendment to the Act on Medicines and Medical Devices effective January 1, prohibits the holder of a license to provide pharmaceutical care from entering into storage agreements whose subject matter is the storage of a human-use categorized medicinal product and a medicinal product included in the list of medicinal products with an officially determined price, with the exception of the storage of a medicinal product procured by a health insurance company. In such a case, the holder is authorized to enter into storage contracts.
- Establishment of an Ethics Committee
- The amendment to the Act on Medicines and Medical Devices established an Ethics Committee to evaluate the scientific, medical, and ethical aspects of clinical trials of human medicines, and included within the Committee’s scope of authority the obligation to issue an opinion on every application for authorization of a clinical trial of a human medicine.
