Due to the current state of emergency in the Slovak Republic caused by the spread of the novel coronavirus, which causes COVID-19, as a result of the unpreparedness of the competent state authorities, institutions, or individuals, and not least due to the depletion of business inventories in response to the rapidly deteriorating epidemiological situation (as well as for their own commercial activities), this period is characterized by a shortage of personal protective equipment, medical supplies, supplies, and materials necessary to stop or mitigate the spread of this disease.
In practice, we commonly encounter shortages of protective face coverings, various types of respirators, full-body protective suits, goggles, and, last but not least, respiratory devices in healthcare facilities—these supplies are lacking not only for the needs of healthcare workers and healthcare facilities but also for all segments of the general population, especially the most vulnerable (the elderly and the sick). This situation is exacerbated by the fact that these goods are in short supply not only in brick-and-mortar stores and online shops within the Slovak Republic and individual European Union countries, but as of today, it can be stated that these goods are virtually unavailable, or available only with great difficulty.
In response to this situation and the shortage of the aforementioned goods, particularly protective face masks, naturally, many entities are not only engaging in business activities (retail and wholesale), but also “home production” of these protective masks—in the Slovak context, this primarily involves sewing textile protective masks and their subsequent sale at a nominal price or at cost, or their subsequent donation.
However, even in such an unfavorable situation as the one resulting from a shortage of the goods in question on the market to meet everyone’s needs, it is essential to bear in mind that in the production, import, sale, or distribution of protective masks or other similar goods, it is necessary to comply with all applicable and effective legal regulations, not only under Slovak legislation but, above all, under European legislation, which regulates the issue of such goods at the pan-European level (primarily through directives as well as directly through regulations).
The purpose of this article is to briefly outline, particularly for business entities, which legal regulations apply to so-called protective face masks and which must be observed and applied when importing, selling, or distributing protective face masks. Of course, the application of relevant legal regulations always depends on the specific type of goods or the type of protective mask, its classification, or other assessments of its status. Generally, however, it can be stated that the main legal regulations that must be known before placing protective masks on the market in the Slovak Republic include:
- Customs, tax regulations, and regulations generally governing business activities:
- Act No. 455/1991 Coll. Act on Trade Licensing (Trade Licensing Act)
- Act No. 199/2004 Coll. Customs Act and on Amendments to Certain Acts, as amended
- Decree of the Ministry of Finance of the Slovak Republic No. 161/2016 Coll., implementing certain provisions of Act No. 199/2004 Coll., the Customs Act, and amending and supplementing certain acts, as amended
- Commission Implementing Regulation (EU) 2019/1776 of October 9, 2019, amending Annex I to Council Regulation (EEC) No. 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff
- Act No. 222/2004 Coll. Value Added Tax Act, Annex No. 7 (list of goods subject to a reduced VAT rate)
- Status of protective face masks as medical devices
- Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts, as amended (hereinafter also referred to as the “Act on Medicines and Medical Devices”)
- Act No. 56/2018 Coll. on product conformity assessment, making a designated product available on the market, and amending certain acts
- Slovak Government Regulation No. 569/2001 Coll. laying down details on technical requirements and conformity assessment procedures for in vitro diagnostic medical devices
- Government Regulation of the Slovak Republic No. 582/2008 Coll. laying down details on technical requirements and conformity assessment procedures for medical devices
- Government Regulation of the Slovak Republic No. 527/2008 Coll. laying down details on technical requirements and conformity assessment procedures for active implantable medical devices
- Act No. 577/2004 Coll. on the scope of healthcare covered by public health insurance and on payments for services related to the provision of healthcare, as amended
- Act No. 363/2011 Coll. on the scope and conditions of reimbursement for medicines, medical devices, and dietary foods under public health insurance
- Legislation on conformity assessment/product certification
- Regulation of the Government of the Slovak Republic No. 404/2007 Coll. on general product safety
- Act No. 56/2018 Coll. on product conformity assessment, making a specific product available on the market, and amending certain acts
- Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/ EEC Regulation of the Government of the Slovak Republic No. 582/2008Coll., laying down details on technical requirements and conformity assessment procedures for medical devices, transposing Council Directive No. 93/42/EEC on medical devices
Our law firm has many years of experience in providing legal services to clients in the field of pharmaceutical law. We have long dealt with the status of medicines and medical devices from the various perspectives of different market participants (primarily holders of licenses to provide pharmaceutical care, licenses for the wholesale distribution of medicines and medical devices, and licenses for the manufacture of medicines). We are ready to assist you immediately and provide legal services, including, among other things:
- in assessing and complying with obligations in customs proceedings and in communicating with customs authorities, obligations regarding the release of goods into free circulation, and in handling so-called import formalities, as well as tariff and non-tariff measures (customs duty rates, application of additional duties, value-added tax, etc.)
- determining all obligations regarding the assessment of goods—specifically, protective masks as medical devices—and their classification into various categories of medical devices based on the type of protective mask
- in procedures for the notification/registration of medical devices at the State Institute for Drug Control pursuant to the Act on Medicines and Medical Devices
- assessing the necessity of obtaining various certificates, declarations of conformity, or other documents required to comply with other technical requirements or technical standards
- acting as your legal representative in communications with any relevant state authority
- legal consultations to ensure the appropriate (and advantageous) structuring of your business relationships
If you are interested in our services or would like further information, please do not hesitate to contact us:
email: info@legalfirm.sk
tel.: +421 908 602 017, +421 908 602 103
web: www.legalfirm.sk
We look forward to working with you!
