The Life Sciences Law Review: Ukraine
The life sciences sector in Ukraine is governed by a number of legislative acts, inter alia, the following laws of Ukraine: (1) On Medicinal Products; (2) Fundamentals of Ukrainian Legislation on Healthcare; (3) On Narcotic Drugs, Psychotropic Substances and Precursors; (4) On Advertising; (5) On Protection against Unfair Competition; (6) On Consumers' Rights Protection; (7) On Ensuring the Functioning of the Ukrainian Language as the State Language; (8) On Copyright and Related Rights, as well as Technical Regulations on medical devices, Technical Regulations on in vitro diagnostic medical devices, Technical Regulations on active implantable medical devices and other by-laws.
The main national competent authorities for medicines and medical devices are the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control. In addition, the State Service of Ukraine on Food Safety and Consumers' Rights Protection is authorised to conduct control in the sphere of advertising and pricing. Moreover, the Antimonopoly Committee of Ukraine (i.e., the national antitrust and competition authority) is highly interested in the life sciences sector, which is considered to be socially significant, and therefore regularly launches a number of investigations related to advertising, labelling and pricing of the products in this area.
In September 2021 a new Draft Law On Medicinal Products was adopted in the first reading and is currently pending the second reading. The Draft Law proposes to establish a new regulatory body that would be responsible for exercising control over advertising of medicinal products.
The life sciences sector in Ukraine is heavily regulated and faces constant changes in the legislation, as well as reforming of the state authorities. Inter alia, taking into account the European Union (EU)–Ukraine Association Agreement,2 Ukraine is in the process of harmonising some pieces of its legislation with the EU law.
In this chapter we briefly summarise the most important issues in the life sciences sector to outline the main red flags in this area.
The regulatory regime
Medicines are mainly regulated by the law of Ukraine On Medicinal Products, which governs development, registration, production, quality control and sale (both wholesale and retail trade) of medicinal products. Medical devices (depending on their type: in vitro diagnostic medical devices, active implantable medical devices or other medical devices) are regulated by relevant Technical Regulations.
Ukrainian legislation distinguishes medicinal products, food products (including dietary supplements and food products for special medical purposes), medical devices and cosmetic products, in particular, the following.
These are defined as:
- any substance or combination of substances (one or more active pharmaceutical ingredients (APIs) and excipients) having properties and intended for the treatment or prevention of diseases in humans; or
- any substance or combination of substances (one or more APIs and excipients), that may be intended to prevent pregnancy, to restore, correct or alter physiological functions of a person by performing a pharmacological, immunological or metabolic action or to establish a medical diagnosis.3
The types of medicinal products include: biological medicinal products, immunobiological medicinal products, biosimilars, generics, hybrid medicinal products, radiopharmaceutical medicinal products, blood-derived medicinal products, homeopathic medicinal products, herbal medicinal products, advanced technological (biotechnological) medicinal products, advanced therapy medicinal products, genetic engineering medicinal products, narcotic (psychotropic) medicinal products and orphan medicinal products.
These are defined as any instrument, machine, device, appliance, software, material or other product used either individually or in combination with each other (including software provided by the manufacturer for use specifically for diagnostic or therapeutic purposes and necessary for the proper functioning of the medical device), intended by the manufacturer for use in:
- diagnosing, preventing, monitoring, treating or alleviating the patient's disease in the event of illness;
- diagnosing, monitoring, treating, alleviating or compensating for the patient's injury or disability; and
- research, replacement, modification or maintenance of anatomy or physiological process, control of the fertilisation process and the main expected effect of which in the body or on the human body is not achieved by pharmacological, immunological or metabolic means, but the functioning of which can contribute to such functions.4
Besides, the Ukrainian legislation also distinguishes some types of medical devices, such as in vitro diagnostic medical devices, active implantable medical devices, as well as medical devices intended for clinical trials (i.e., medical devices intended for use by a qualified medical professional during clinical trials) and disposable medical devices (i.e., medical devices intended for use only once for only one patient).
These are defined as a substances or products (unprocessed, partially processed or processed) intended for human consumption. Foods include beverages (including drinking water), chewing gum and any other substance that is specifically included in the food product during production, preparation or processing. Ukrainian legislation clearly stipulates that the notion of a food product does not cover such concepts as medicinal products and cosmetic products.5
Ukrainian law also distinguishes the following:
- A food product for special medical purposes (i.e., a specially developed and manufactured product that is consumed under the supervision of a physician). This type of product is intended to partially or completely replace the normal diet of patients with limited, impaired or faulted ability to take, digest and assimilate normal foods or certain nutrients contained in them, or their metabolites. Foods for special medical purposes may also be intended for the complete or partial feeding of patients with other needs determined by doctors, which cannot be met by modifying the usual diet.
- A food product intended for weight control (i.e., a specially developed and manufactured product that is intended for consumption in energy-restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet).
- A dietary supplement (food supplement) (i.e., a food product that is consumed in small defined quantities to supplement the normal diet and that is a concentrated source of nutrients (including proteins, fats, carbohydrates, vitamins, minerals, etc.) and manufactured in the forms of tablets, capsules, powders, liquids or other forms.
These are defined as products used to care for skin, hair, mouth or perform hygienic, preventive and aesthetic functions.6
Some companies face a number of issues related to re-classification of imported products by the Ukrainian customs authorities. For instance, there was a case when the customs authorities re-classified a food (dietary) supplement into a confectionary.
ii Non-clinical studies
Non-clinical studies are governed by the procedure for conducting preclinical studies of medicinal products and evaluation of materials of preclinical studies of medicinal products, approved by the Order of the Ministry of Health of Ukraine No. 944 dated 14 December 2009. In addition, the OECD Principles of Good Laboratory Practice (GLP) have been incorporated into the Ukrainian system of standards and must be complied with.
Preclinical studies include three streams: (1) establishment of pharmacological effectiveness; (2) examination of pharmacokinetics; and (3) toxicological studies. Preclinical studies must be carried out in compliance with the principles of bioethics and the humane treatment of laboratory animals.
Preclinical studies shall start after the evaluation of its ethical, moral and legal aspects, as well as the approval of its protocol (plan) in written form. Based on the results of a preclinical study, a report shall be prepared. The report shall be submitted by the sponsor of the preclinical study to the State Enterprise 'State Expert Centre of the Ministry of Health of Ukraine' for an evaluation of materials of preclinical studies. Based on the results of the evaluation, a positive or negative conclusion is issued.
The rules on treating animals used in scientific experiments (experimental animals) are established in the Law of Ukraine On the Protection of Animals from Cruel Treatment (Article 26). In particular:
- the use of experimental animals is allowed only in case there is no possibility to replace them with other alternative methods and objects;
- working with experimental animals requires a permit issued by the Ministry of Education and Science of Ukraine;
- if procedures on experimental animals may endanger them or cause them acute or prolonged painful irritation, anaesthesia must be used;
- an experimental animal, which has already been used in the procedure, may be used in the next procedure only after its health has rebounded to the normal condition and if general anaesthesia is applied and only minor interventions are involved;
- it is prohibited to use animals for which it is difficult to tolerate captivity, confined space, training;
- devocalisation and traumatic methods in the selection of cells from animals are prohibited;
- experimental animals shall be provided with qualified care; and
- an unviable experimental animal shall be deprived of life by euthanasia (by overdosing anaesthetics) before it starts to suffer.
iii Clinical trials
Clinical trials are governed by the procedure for conducting clinical trials of medicinal products and evaluation of materials of clinical trials, approved by the Order of the Ministry of Health of Ukraine No. 690 dated 23 September 2009. In addition, the EU Guideline for good clinical practice (GCP) has been incorporated into the Ukrainian system of standards and must be complied with.
There are no requirements for the sponsor to be established as a local entity in Ukraine.
To start a clinical trial, prior approvals by the Ministry of Health of Ukraine and research ethics committees of healthcare facilities, in which clinical trials are planned to be conducted, are required. To obtain these approvals, the sponsor must submit the appropriate sets of documents.
According to current legislation, concluding a life and health insurance contract of the patient (volunteer) is necessary for starting a clinical trial. The size of compensation is not established by the legislation, but information on compensation or treatment in case of damaging his or her health must be included in the information provided to the patient (volunteer) prior to him or her giving an informed consent.
Recently, on 18 November 2021 a new Law On Insurance was adopted (as of the date of writing, its final text is not publicly available yet). It envisages another type of contract – a contract on insurance of liability of a sponsor of a clinical trial before third parties in case of damaging life and health of trial subjects (patients, volunteers) during participation in a clinical trial. This law shall come into effect on 1 January 2024.
An informed consent of a patient (volunteer) or, if he or she is not able to give consent, of his or her legal representative or close relative is indispensable for a clinical trial. If a child (under 18 years old) participates in a clinical trial, an informed consent of both parents is required. Information on a child's participation in a clinical trial must also be provided to child protection services. To obtain an informed consent, an investigator must provide oral and written information on the clinical trial in an understandable way and without specialised terms. The requirements for the contents of the information to be provided are specified in the above-mentioned Regulation No. 690. The patient (volunteer) or his or her legal representative or close relative and the investigator shall sign and date two copies of the informed consent, one of which is provided to the investigator and the other one is given to the patient (volunteer). The investigator is under an obligation to keep his or her copy for no less than 15 years.
The investigator shall immediately report to the sponsor any serious adverse events, as well as critical adverse events or laboratory abnormalities as specified in the protocol. The investigator must report to the research ethics committee any suspected unexpected serious adverse reactions. The sponsor must notify the State Enterprise (the State Expert Centre of the Ministry of Health of Ukraine) any suspected unexpected serious adverse reactions, as well as having to submit periodic reports containing details on any adverse reactions to it.
Currently investigator-initiated studies are not governed by Ukrainian legislation. The only provision relating to them is the one of the above-mentioned Regulation No. 690, which excludes investigator-initiated studies from the scope of this regulation.
Despite clinical trials legislation in Ukraine being well-developed and largely harmonised with EU legislation, there are some legislative gaps as regards contractual formalisation of clinical trials. The only requirement is that relationships between all the parties involved shall be formalised in respective contracts. Accordingly, in practice there are different contractual formalisation models without a unified approach. In view of this and taking into account recent increased focus of controlling and law enforcement bodies on clinical trials, it is important to formalise relations between all the parties involved in clinical trials in an appropriate way to mitigate a number of risks, inter alia, those related to personal data, insurance, taxation, etc.
iv Named-patient and compassionate use procedures
As for now, named-patient or compassionate use procedures are not envisaged by Ukrainian legislation. Nevertheless, such projects may be implemented under other procedures, provided by the law, such as individual importation or treatment of rare (orphan) diseases.
Please note, a draft law to introduce named-patient or compassionate use procedures is under consideration in the parliament (it has already been adopted in the first reading on 17 November 2021 and is pending the second reading). The Arzinger team participated in developing and promoting the above-mentioned draft law.
v Pre-market clearance
In Ukraine, medical devices are subject to conformity assessment procedures and labelling with the national conformity mark. Currently, medical devices are not subject to state registration in Ukraine, as it was in the past.
In order for a medicine to be circulated in the Ukrainian market, it shall undergo a state registration procedure conducted by the Ministry of Health of Ukraine pending the results of the expertise of register materials conducted by the State Expert Centre of the Ministry of Health.7 The following medicinal products are not subject to state registration: medicines that are made in pharmacies according to doctors' prescriptions (main formulas) and by the order of treatment-and-prophylactic establishments (official formulas) from the active and auxiliary substances that are allowed for use.
There are special requirements to state registration for some types of medicinal products:
- for medicines registered by the European Medicines Agency:
- in such cases where original medicines are registered without conducting an expertise of registration materials for a medicinal product, which is a preliminary and specialised examination of registration materials for a medicinal product in order to prepare reasoned conclusions and recommendations on the decision on its state registration, re-registration, amendments to registration materials or refusal of state registration, re-registration, introduction of changes to registration materials for the medicinal product, which is conducted by the State Expert Centre of the Ministry of Health; and
- application, registration materials, including the report on the assessment of the registration dossier of the mentioned agency, and the conclusion of the State Expert Centre on the compliance of the instructions for use and methods of quality control of the medicinal product with the registration materials are sufficient for such a medicine to be registered in Ukraine;
- for medicines registered by competent authorities of such countries as the United States, Switzerland, Japan, Australia, Canada, under the centralised procedure by the competent authority of the European Union and applied in the territory of such countries or member states of the European Union:
- registration is carried out on the basis of the application and the conclusion of the State Expert Centre;
- simplified procedures are also provided for the state registration of medicinal products that:
- are procured for public funds by an entity authorised to procure in the field of healthcare (e.g., the State Enterprise 'Medical Procurement of Ukraine'); or
- are subject to procurement as a result of the procurement procedure conducted by a specialised procurement organisation (e.g., UNDP, Crown Agents, UNICEF) for the implementation of the procurement agreement between the Ministry of Health and the relevant specialised procurement organisation.
If the application for state registration of the medicine and all submitted materials comply with the legislative requirements, the Ministry of Health issues an order on state registration of a medicinal product which approves methods of quality control, instructions for use of the medicinal product (instructions for medical use), as well as a registration number, which is put into the State Register of Medicinal Products and the interdepartmental database of medicinal products registered in Ukraine.
It is prohibited for five years from the date of state registration of a medicine (regardless of the term of validity of any patent related to the medicinal product) to use registration information on safety and efficacy contained in the application and its annexes of the registered medicinal product for submission of an application for state registration of another medicinal product, except in cases when the right to refer or use such information is duly obtained.
A medicinal product may be used for five years from the date of its state registration, then it is subject to re-registration. After the procedure of re-registration is completed, the use of such medicinal product on the territory of Ukraine is not limited.
Ukrainian legislation envisages some cases when unregistered medicinal products may be imported on the territory of Ukraine, in particular, for the following purposes:
- conducting preclinical studies of pharmaceutical development;
- conducting clinical trials;
- state registration of medicines in Ukraine;
- placing such products at exhibitions, fairs, conferences, etc. without the right of sale;
- providing medical support (without the right to sell) to units of the armed forces of other states, which in accordance with the law are admitted to the territory of Ukraine;
- individual use by citizens;
- treating people in case of natural disasters, catastrophes, epidemics, etc. by the decision of the Ministry of Health of Ukraine;
- for the purpose of medical support of military servicemen by the decision of the Ministry of Health;
- treatment of rare (orphan) diseases by the decision of the Ministry of Health; and
- supply based on the results of public procurement carried out by a person authorised to carry out procurement in the field of healthcare.
For the conduction of a state registration of a medicinal product the applicant must pay a fee in a national or foreign currency. The amount of the fees is calculated in the following way:
- for state registration (re-registration) of medicinal products, including medical immunobiological medicinal products (except for radioactive medicinal products, diagnostic medicinal products, simple or complex (galenic) medicinal products from herbal medicinal raw materials) – in the amount equivalent to €100 for each dosage form, €10 for each subsequent dose, €10 for each subsequent package of the medicinal product; and
- for state registration (re-registration) of radioactive medicinal products, diagnostic medicinal products, simple or complex (galenic) medicinal products from herbal medicinal raw materials, active medicinal products of limited use, medicinal products from donor blood or plasma – in the amount equivalent to €25 for one name, €5 for each subsequent dose, and €5 for each subsequent package of the medicinal product.
vi Regulatory incentives
Supplementary protection certificate
In Ukraine, medicinal products protected by a patent are subject to an administrative authorisation procedure (marketing authorisation) before being put on the market. The period that elapses between the filing of the application for a patent and the first authorisation to place the product on market may shorten the period of effective protection under the patent. To compensate for the respective delay, Ukraine provides for an additional period of protection for a medicinal product which is protected by a patent, and which has been subject to a marketing authorisation procedure. That period is equal to the period from filing the patent application until granting marketing authorisation and reduced by five years.
In the case of medicinal products for which paediatric studies have been carried out, and the results of those studies are reflected in the product information, Ukrainian law provides for an additional six-month extension of protection.
The granted additional protection is confirmed by supplementary protection certificate (SPC) issued by the Patent Office of Ukraine upon request of a patent holder.
The procedure for obtaining SPC provides for strict requirements and timelines, which makes it rather difficult to succeed. Patent protection of medicinal products during SPC validity has a number of limitations compared to regular patent protection; for instance, allowing medicinal product use if intended for export.
The SPC procedure was introduced in 2020 and replaced the similar, but more realistic to obtain, patent term extension procedure, which existed during previous decades.
Since 2020, Ukrainian law allows for the importation and use of patented medicinal products if intended for trials to apply for marketing authorisation. Respective law provision is rather vague, and it is still debated whether it also allows for filing medicinal products for marketing authorisation while the respective patent is valid. No case law is available yet to clarify this.
Ukrainian law provides for data exclusivity for medicinal products first registered in Ukraine for a period of five years. This applies if marketing authorisation application was filed in Ukraine no later than two years after first marketing authorisation issued in any other country of the world.
The data exclusivity means that generics are not allowed to refer to the data of the original marketing authorisation dossier while applying for its generic marketing authorisation.
vii Post-approval controls
Duly registered medicinal products are usually subject to two types of control: incoming quality control and state quality control.
Incoming quality control is conducted when a medicinal product is going to be sold in a pharmacy (retail trade); such control is conducted by the authorised person of the pharmacy. The authorised person is entitled to check medicines that come to the pharmacy, and accompanying documents: invoices, certificates of quality and information about state registration of such medicinal products. Upon the incoming quality control, the authorised person gives permission for the sale of medicinal products.8
The same procedure is provided for the medicinal products that are going to be sold by business entities that have a licence to conduct business in the wholesale trade of medicines.
Medicinal products may also be subject to state quality control, intended inter alia to check accompanying documents, the description, packaging and labelling of medicinal products, visual control of the medicines' conformity with quality requirements, as well as conduct laboratory analysis of the medicine samples.9
Revocation of registration certificate
The Ministry of Health may make a decision on a complete or temporary ban on the use of a medicinal product by terminating the registration certificate, if:
- the medicinal product is harmful to human health or therapeutic efficacy is absent if used in accordance with the instructions;
- the composition of the medicinal product does not correspond to that specified in the registration documents;
- registration documents or information on changes to them provided by the applicant are unreliable;
- the applicant does not ensure the implementation of all types of quality control of the finished medicinal product or its ingredients specified in the registration documents, as well as the control carried out at the intermediate stages of production in accordance with the registration materials;
- dangerous properties of the medicinal product were identified; and
- the medicinal product has not been put into circulation in the territory of Ukraine within three years from the moment of its state registration (re-registration), unless this is as a result of the specifics of production or use of such medicinal product.
viii Manufacturing controls
Production of medicines is carried out by individuals or legal entities based on a licence. The appendix to the licence shall contain a list of forms of medicinal products permitted for the manufacture by the licensee, as well as special conditions of carrying out the activity. The licensee is entitled to conduct the wholesale of medicinal products listed in the manufacturing licence without obtaining a separate licence for wholesale trade of medicinal products.
The basis for the issuance of a licence is the availability of appropriate material and technical base, qualified personnel, as well as conditions for quality control of medicines to be produced. Compliance with the material and technical base, staff qualifications, as well as the conditions for quality control of manufactured medicines, the established requirements and the characteristics stated in the documents submitted by the applicant for a licence are subject to mandatory verification before issuing a licence.
The general requirements to the material and technical base for the production of medicines, production control of their quality, as well as technological regulations are set by the Ministry of Health.
The production of medicines is carried out according to the technological regulations in compliance with the requirements of pharmacopoeia articles and other state standards, technical conditions, considering international standards for the production of medicines. Manufacturers must comply with good manufacturing practice (GMP) standards that are based on EU Guidelines. Compliance with GMP standards for residents and non-residents is confirmed by the State Service of Ukraine on Medicines and Drugs Control (the Service). The Service conducts expert evaluation of the documents submitted by the applicant, as well as through inspecting manufacturing facilities. A simplified procedure of GMP certification (no inspection of manufacturing facilities is conducted except for some limited cases) is used for the facilities having GMP certificates issued by EU countries, the United Kingdom or a country having a mutual recognition agreement with the EU or Ukraine.
Compliance with licensing terms and conditions is subject to regular control by the State Service of Ukraine on Medicines and Drugs Control.
ix Advertising and promotion
The main state authorities responsible for control of medicines advertising are:
- the State Service of Ukraine on Food Safety and Consumers' Rights Protection, which ensures that the rights of advertising consumers are protected; and
- the Antimonopoly Committee of Ukraine, which exercises control over compliance by business entities with legislation on protection against unfair competition.
In addition, the Draft Law On Medicinal Products proposes to establish a new regulatory body that would be responsible for exercising control over advertising of medicinal products.
According to the Ukrainian legislation, the advertising of medicines and medical devices to the general public shall comply with both: (1) general rules, which are applicable to all types of advertising of any products; and (2) special requirements and restrictions applicable to medicines and medical devices.
Advertising is subject to a number of general requirements; for instance, the advertisement must not, inter alia:
- contain misleading information (including incomplete, inaccurate or false information, in particular as a result of the chosen method of presentation, omission of certain facts or vagueness of wording that has affected or may affect the intentions of persons to purchase, order or sell products);
- use tools and technologies that have impact on the subconscious of consumers of advertising;
- contain statements that are discriminatory, as well as such that discredit the products of others;
- use or imitate the image of national symbols of Ukraine; and
- advertise goods the production or sale of which requires a licence, in the absence of the licence; etc.
In addition, the law contains a number of requirements to:
- advertising about discounts or sale;
- advertisements for competitions, lotteries, prize draws, promotional events;
- placing an image of a natural person or using his or her name in the advertising; and
- intellectual property rights protection in advertising, etc.
Since December 2019, as a result of recent legislative changes, it became possible to use comparative advertising if it meets a number of criteria; inter alia, does not contain signs of unfair business practice (e.g., is not misleading and aggressive), objectively compares the characteristics or price of homogeneous (similar) products or products with the similar indication of origin, does not discredit or create confusion, etc.
In addition, comparative advertising may attract the attention of the Antimonopoly Committee of Ukraine as a potential source of unfair competition.
There are also a number of special requirements and restrictions applicable to the advertising of medicinal products and medical devices, for example:
- Advertising is allowed for :
- only such medicines and medical devices that are duly permitted for use in Ukraine; and
- only over-the-counter medicines (i.e., those medicinal products that are available without a doctor's prescription) and those that are not included in the list of medicinal products prohibited for advertising under Ukrainian legislation.
- Advertising of medicines and medical devices must contain:
- objective information about the product, and shall be carried out so that it is clear that the message is advertising, and the advertised product is a medicinal product or medical device;
- the requirement to consult a doctor before using a medicinal product or medical device;
- a recommendation for mandatory reading of the instructions for the medicinal product; and
- the warning text: 'Self-medication can be harmful to your health', which occupies at least 15 per cent of the area (duration) of all advertising.
- There are restrictions, for example, in the advertising of medicines or medical devices, which shall not contain:
- information that may give the impression that consultation with a specialist is not required when using a product;
- information that the therapeutic effect of the use of the product is guaranteed; and
- images of changes in the human body or its parts as a result of illness, injuries; etc.
- The participation of doctors and other professional medical workers, as well as persons whose appearance imitates the appearance of doctors, is prohibited in the advertising of medicinal products and medical devices.
- It is prohibited to place in the advertising of medicinal products information which suggests that the medicinal product is a food, cosmetic or other consumer product or that the safety or efficacy of the medicinal product is as a result of its natural origin, etc.
The Ukrainian legislation also envisages a number of requirements to promote medicines and medical devices among healthcare professionals (HCPs). Moreover, the Code of Pharmaceutical Marketing Practices of Association of Pharmaceutical Research and Development ('the APRaD Code of Ethics') also regulates the promotion of Rx medicines.
On 16 March 2021, the Antimonopoly Committee of Ukraine (the AMCU) issued its Recommendations regarding the advertising of medicinal products. The AMCU defined a number of red flags in advertising claims and possible risk mitigation tools, inter alia, those related to:
- the duration of action (e.g., such claims as 'quick relief', 'immediate symptom removal', 'at the first application', 'in a few minutes');
- leading position (e.g., 'number one worldwide', 'leader', 'the newest');
- price (e.g., 'affordable price', 'moderate price', 'reasonable price');
- quality (e.g., 'high quality', 'the highest quality'); and
- covid-19 (i.e., referral to a product's property to treat or prevent covid-19).
Please note, both of the most significant enforcement actions in the field of pharmaceutical advertising in the past two years relate to advertising of 'anti-covid-19' medicinal products, when the AMCU imposed fines on two pharmaceutical companies in the amount of 528,004 hryvnas (approximately US$20,000) and 3,210,464 hryvnas (approximately US$120,000), respectively. Besides, one of these companies managed to successfully appeal the AMCU's decision in the Supreme Court.
x Distributors and wholesalers
Wholesale trade in medicines in the territory of Ukraine is carried out by business entities based on a licence for a wholesale trade in medicines. An entity having a licence for importation of medicines may conduct wholesale trade of medicines listed in that licence without obtaining a separate licence for a wholesale trade.
The basis for the issuance of a licence is the availability of a material and technical base and qualified personnel. Compliance with the established requirements is subject to mandatory verification by the State Service of Ukraine on Medicines and Drugs Control before issuing a licence.
Compliance with licensing terms and conditions is subject to regular control by the State Service of Ukraine on Medicines and Drugs Control.
Licensing terms and conditions provide for mandatory compliance of the distributors and wholesalers with good distribution standards (GDP) standards, harmonised with EU guidance. To monitor compliance with the requirements of GDP, self-inspection is carried out. The licensee shall implement a self-inspection programme covering all aspects of good distribution practice and compliance with regulatory provisions, rules and procedures, in accordance with a set schedule.
Certification of business entities that carry out wholesale trade in medicines in accordance with the requirements of GDP is carried out by the State Service of Ukraine on Medicines and Drugs Control on a voluntary basis.
xi Classification of products
The basic classification of medicinal products is prescription-only (Rx) and non-prescription, over-the-counter (OTC) medicinal products. The classification is decided by the Ministry of Health when it grants the marketing authorization; however, the applicant for a marketing authorisation has to identify in the initial application a proposed classification of the product.
Classification of a medicinal product would affect the medicinal product's ability to be advertised (only OTC products may be advertised to the general public, for more details please see Section II.ix) and be displayed on the pharmacies' transparent shelves. Additionally, only OTC products can be sold online, unless there is an electronic prescription for prescription-only medicinal products.
There is also a separate classification of medicinal products that are procured by specialised procurement organisations or a specialised medical procurement body and may be supplied to the territory of Ukraine with labelling in foreign languages. Such medicines are subject to hospital-only use.
Classification of medical devices is based on EU Directives on medical devices, IVD devices and implantable devices. Medical devices are classified as Class I, IIa, IIb or III, depending on their characteristics and the potential risk to patients.
xii Imports and exports
Customs clearance of the products can be carried out in one of 14 customs procedures (regimes) provided by the Customs Code of Ukraine. There are the following general customs obligations to place the goods under the import procedure:
- to submit an import customs declaration;
- to provide the customs authority with the documents related to the products; and
- to pay customs duties (if applicable).
Once the customs control and customs clearance are completed, the goods may be released for free circulation. Return of the products may be made under the export procedure.
Medicines registered in Ukraine may be imported into Ukraine if they have a quality certificate of a batch of a medicinal product issued by the manufacturer and a licence to import medicinal products issued to the importer. The appendix to the licence shall contain a list of medicinal products permitted for import by the licensee.
The basis for issuing a licence to import medicines is the availability of an appropriate material and technical base, qualified personnel, as well as conditions for quality control of medicines that will be imported into Ukraine.
The shelf life of medicinal products imported into Ukraine must be at least half of the period specified by the manufacturer, provided that the manufacturer has specified a period of less than one year, or at least six months, provided that the manufacturer has specified a period of more than one year.
All medicines imported into the customs territory of Ukraine for the purpose of their further sale (trade) or use in the production of finished medicines are subject to the state quality control. Control over the import of medicines into the customs territory of Ukraine is carried out by the State Service of Ukraine on Medicines and Drugs Control.
The legislation provides an exhaustive list of cases when unregistered medicines can be imported into Ukraine.
Medical devices may be imported to the territory of Ukraine provided they are compliant with technical regulations, labelled conformity mark and supported by either self-declaration of conformity or conformity certificate issued by the notified body (depending on a class of medical device) and provided a local authorised representative of a foreign manufacturer is appointed. Exceptions are applicable to medical devices used for diagnosis and treatment of covid-19.
Exports of medicinal products (except for controlled substances) and of medical devices is not subject to licensing or other forms of regulatory approvals. Products subject to exportation must comply with the requirements of the country to which they are exported.
xiii Controlled substances
The Law of Ukraine On Narcotic Drugs, Psychotropic Substances and Precursors divides controlled substances into several groups: the sale of some controlled substances is prohibited in Ukraine, while the sale of other controlled substances is limited and special control measures are applied.
The above-mentioned law establishes the main rules and requirements applicable to controlled substances. Inter alia, a number of activities related to the circulation of narcotic drugs, psychotropic substances and precursors are subject to licensing.
As at the time of writing, the cannabis market in Ukraine is not fully legalised, as this herb and cannabinoids are referred to a group of substances, the circulation of which is prohibited.10 However, on 7 April 2021 the Cabinet of Ministers of Ukraine adopted a resolution that permits the use of some cannabis-based products for medical purposes.11 This resolution was criticised by some patient organisations and members of the Ukrainian parliament as it does not fully solve the problem of lack of patient access to the necessary medicinal products based on medical cannabis. Some members of the Ukrainian parliament have made a number of attempts to initiate, promote and support adoption of a new law that would allow fuller legalisation of medical cannabis.
As a result, on 17 November 2021 the Draft Law On Amendments to Certain Legislative Acts of Ukraine Concerning the Regulation of the Circulation of Cannabis Plants for Medical, Industrial Purposes, Scientific and Scientific-Technical Activities was submitted for public discussion. This new draft law was developed by the Ministry of Health of Ukraine with support from the State Enterprise 'Medical Procurement of Ukraine'. This draft law intends to regulate the amount of tetrahydrocannabinol in dry mass in varieties of plants of the genus Cannabis for medicinal purposes as well as establish a number of requirements for business entities that plan to cultivate varieties of plants of the genus Cannabis for medical purposes, manufacture and circulate medicines produced based on Cannabis. As far as the concept of this draft law is highly supported by a number of members of the Ukrainian parliament, this draft law has quite a high chance of being adopted in 2022.
Enforcement with respect to both medicinal products and medical devices is mainly undertaken by the State Service of Ukraine on Medicines and Drugs Control. The key forms of enforcement are:
- checking compliance with licensing terms and conditions;
- state quality control of medicinal products (after importation and during their circulation on the Ukrainian market); and
- market surveillance over medical devices.
Penalties may range from administrative fines (may be imposed by the above-mentioned State Service) to criminal punishments (only applied by courts after involvement of law-enforcement agencies).
Withdrawal, recall, ban on sales and suspension of marketing authorisation may be applied to the products in case of violations.
Significant attention is paid to enforcement in terms of pricing legislation. The State Service of Ukraine on Food Safety and Consumers' Rights Protection (SSUFSCP) is the body authorised to conduct inspections of the companies' compliance with pricing regulations. SSUFSCP is entitled to conduct scheduled and non-scheduled checks of business entities' compliance with pricing regulations, to issue warnings and to fine violating entities.
The AMCU pays particular attention to the pharmaceutical market. Since 2013 the AMCU has conducted a series of large-scale investigations with respect to pharmaceutical companies (Alcon, Servier, Sanofi, GSK, Novo Nordisk, Roche, etc.) that ended in significant fines for anticompetitive concerted actions between pharmaceutical companies and their local distributors. Some of the fines have been paid (Alcon, Servier), some of the decisions have been successfully appealed in courts (Roche, Sanofi) and some are still being considered by local courts (GSK, Novo Nordisk). The AMCU has issued a series of recommendations for the pharmaceutical market (e.g., recommendations on the application of legislation on the protection of economic competition by pharmaceutical market players in vertical relations for the supply and promotion of medicinal products, a series of covid-related documents, etc.).
Pricing and reimbursement
Ukrainian legislation does not impose an obligation of marketing authorisation holders to obtain approval of the price or reimbursement status of medicinal products before they are placed on the market. In case a marketing authorisation holder plans to sell medicinal products for public funds, it is obliged to declare the wholesale price in advance. Requirements on declaration of wholesale prices are not imposed on those medicines, which are procured for the costs of the state budget of Ukraine by specialised international funds and organisations (UNDP, UNICEF, Crown Agents) and the State Enterprise 'Medical Procurement of Ukraine' (the SE). In case the marketing authorisation holder is willing to participate in reimbursement, it must submit the price of the medicinal product subject to reimbursement to the Ministry of Health, which will include it into the Register of Medicines Subject to Reimbursement provided that price meets requirements set by legislation.
The purchase of medicinal products for public funds in Ukraine is arranged based on different positive lists (e.g., National Essential Medicines List, List of International Nonpropietary Names Subject to Centralised Procurement, etc.) and on the requirement to declare wholesale price (importation price (for imported products) or price of manufacturer (for locally manufactured products)) of medicinal products that are procured for public funds or are reimbursed.
An important aspect of the Ukrainian public procurement system in the pharmaceutical area is the application of 'centralised procurements' (procurements made for the funds of the Ministry of Health for treatment of the most socially significant diseases (child oncology, hepatitis, orphan diseases, HIV, etc.)). This procurement is conducted by the SE, which is an entity specially created in 2019 to ensure transfer of the centralised procurement function from the specialised funds and organisations (UNDP, UNICEF, Crown Agents), which have been procuring medicines on behalf of the Ministry of Health since 2015, and whose role is decreasing as the SE gains more practical procurement experience and good standing. It is expected that, beginning in the spring of 2022, all the centralised procurements will be conducted exclusively by the SE, except for some covid-related procurement. Starting in November 2021, a pilot project on the centralisation of localised procurement is being implemented allowing local healthcare facilities to voluntarily aggregate their demands and to request the SE to conduct tenders on their behalf to ensure more professional conduct of tender procedures and more savings as a result of aggregated amounts of procured medicines and medical devices.
With regard to medicinal products that are purchased for public funds or included in the National Essential Medicines List (save for narcotic, psychotropic medicinal products, precursors and medical gases), marginal wholesale and retail mark-ups are established in the amount of 10 per cent and 10–25 per cent depending on the wholesale price, respectively. With regard to insulin products, marginal wholesale and retail mark-ups are established in the amount of 10 per cent for each of them. With regard to products subject to reimbursement (except for insulin products), wholesale mark-ups are 10 per cent, and retail mark-ups are 15 per cent.
In March 2020, legislative amendments drafted by Arzinger lawyers and supported by the Ukrainian parliament provided for the possibility of concluding Managed Entry Agreements (MEA) between the Ministry of Health (or SE on behalf of the Ministry) and the innovative products' marketing authorisation holders. The MEA are intended to allow purchasing innovative medicines at the expense of the state budget while ensuring price confidentiality, while the information about the existence of the contract itself will be publicly available.
The list of medicines that can be purchased under the MEA is determined exclusively by the Cabinet of Ministers of Ukraine.
The conclusion of a MEA will be preceded by the health technology assessment (HTA), and the first HTA conclusions have already been published. Negotiations on concluding first MEAs are ongoing between the Ministry of Health and innovative pharmaceutical manufacturers as of today.
Control over compliance with requirements of pricing laws is vested in the State Service of Ukraine on Food Safety and Consumers' Rights Protection, but the Antimonopoly Committee of Ukraine (an authority in charge of antitrust and competition – the AMCU) within investigations on competition and antitrust violations ongoing on the pharmaceutical market tends to control 'fairness' of the profit margin received by business entities operating on the market. There have already been multimillion hryvna fines imposed on a number of global pharmaceutical companies and their local distributors for 'excessive pricing' on medicines supplied to the public market.
Health Technology Assessments are introduced in limited scope only for those medicines that are planned to be included in the National Essential Medicines List, medicinal products subject to Managed Entry Agreements and medicinal products procured for the state budget funds (centralised procurement). As the HTA procedure has only been introduced in late 2020, there is not much practice in this respect, and the companies and the involved authorities still need to figure out the way the HTA will work in Ukraine. Currently, Ukraine is in the process of establishing the legal framework for concluding MEAs, which are expected to be concluded based on the HTA results, including information about clinical and cost effectiveness.
As for medical devices, they are currently not subject to pricing regulation and reimbursement; however, some legislative initiatives are being actively discussed to introduce reimbursement of medical devices as well.
Administrative and judicial remedies
There are several state authorities that have competence in the life sciences sector, inter alia:
- the State Service of Ukraine for Medicinal Products and Drug Control, which:
- is responsible for safety of medicines and medical devices;
- has the right to take measures to eliminate violations, inter alia, may impose a ban or a temporary ban on the product's circulation, withdraw products from circulation, initiate termination of the marketing authorisation certificate and suspend the relevant series of medicines from circulation; and
- informs law enforcement authorities about the violations it has detected (in such cases law enforcement agencies may initiate criminal proceedings based on the information received);
- the Ministry of Health of Ukraine, which acts through the State Expert Centre:
- is responsible for safety of medicines;
- can impose restrictions on the use of medicines or submit proposals to the Ministry of Health for a full or temporary prohibition of the use of such medicines, if defects in medicine quality are found;
- can conduct post-registration control and prepare materials to withdraw from circulation or prohibit the use of medicinal products that do not comply with the established legislative requirements and registration dossiers; and
- can exclude from the market medicinal products the risk of which prevails over the benefit, and submit proposals to the Ministry of Health for the termination of the applicant's registration certificate, if defects in the pharmacovigilance system are found;
- the State Service of Ukraine on Food Safety and Consumers' Rights Protection, which is responsible for control over product advertising, compliance with the state pricing regulation, as well as control over safety of food products (including dietary supplements);
- the Antimonopoly Committee of Ukraine (i.e., an antirust and competition authority), which focuses its particular attention on advertising, labelling and pricing of the products in the life sciences sector;
- the Security Service of Ukraine is entitled to conduct investigations upon the receiving of information of committing such criminal offence as illegal trafficking of counterfeited medicinal products;
- the national police of Ukraine are entitled to conduct investigations related to the below-mentioned criminal offences:
- illegal production, manufacture, acquisition, transportation, transfer, storage for the purpose of sale or sale of poisonous or potent medicinal products;
- counterfeiting or circulation of counterfeited medicinal products; and
- intentional violation of the established procedure for preclinical studies, clinical trials of medicinal products, falsification of their results, as well as violation of the established procedure for state registration of medicinal products.
Claims of individuals and business entities related to medicines and medical devices may be submitted to the abovementioned state authorities, as well as to the courts, depending on the particular circumstances of the case.
Consumer associations in Ukraine have the right to sue in court the actions of the seller or manufacturer that caused damages to an indefinite number of consumers. However, currently class actions are not well-developed in Ukraine because of the following reasons:
- long duration of consideration by courts;
- problems in reaching agreement on all key procedural issues between all plaintiffs;
- absence of common legal position in the case; and
- lack of practice in defining and representing the 'indefinite number of consumers'.
Financial relationships with prescribers and payers
Financial relationships with prescribers and payors are governed by general provisions of Ukrainian anticorruption legislation and criminal laws prohibiting corrupt practices both in public and private sectors.
Additionally, the HCPs are prohibited from:
- receiving illegal benefit from business entities engaged in the production or sale of medicines, medical devices, or their representatives;
- receiving from business entities engaged in the production or sale of medicines, medical devices, their representatives' samples of medicines, medical devices for use in professional activities (except in cases related to the conduct of clinical trials); and
- advertising medicines, medical devices (including prescribing medicines on forms containing information of an advertising nature) and indicating the manufacturers of medicines (trademarks) when prescribing.
In addition, industry codes of conduct, such as the APRAD code of conduct for innovative pharma and others, provide for stricter rules of conducts with prescribers and payors. For instance, the APRAD code provides for obligatory disclosure of all payments made in favour of HCPs (either directly or indirectly).
There are a number of legal models for cooperation of pharmaceutical companies with the HCPs, inter alia, engaging HCPs as key opinion leaders in a number of activities (e.g., speaking at conferences etc.) or participants of events organised by third parties. In addition, applying a number of risk mitigation tools while cooperating with HCPs is highly recommended.
Special liability or compensation systems
A patient may submit to the State Expert Centre of the Ministry of Health of Ukraine the information on adverse medicine reaction, vaccine, tuberculin, or lack of efficacy of the medicine or adverse events after immunisation and tuberculin diagnosis.
If a patient is sure that a doctor prescribed a wrong medicinal product, the patient can initiate a procedure to summon a Clinical Expert Commission, an advisory body that is authorised, inter alia, to inform the Ministry of Health and structural units for healthcare of local administrations on the qualification of specialists who provided medical care, to take appropriate measures to respond to violations made by such specialists. Though the conclusions of the Clinical Expert Commission are not binding, they can be used as evidence in court in civil and criminal cases.
According to the general rule established by the Civil Code of Ukraine, a person who has suffered property or moral damage has the right to compensation. Property damage includes costs incurred or forced to be incurred (actual losses) and income that a person could actually receive under normal circumstances (lost benefit), and moral damage includes physical pain and suffering because of injury or other damage to health and mental suffering that the person reported in connection with illegal behaviour towards themselves, family members or close relatives.
The following types of damage may be subject to reimbursement:
- earnings (income) lost by the victim as a result of loss or reduction of professional or general ability to work;
- average income in case of death of the victim – to the victim or incapacitated persons who were dependent on him or her;
- additional costs (for intensive nutrition, sanatorium treatment, purchase of medicines, prosthetics, third-party care, etc.) – to the victim or persons who committed them;
- expenses for burial and construction of a tombstone – to the person who made them;
- moral damage caused by injury or damage to health – to the victim; and
- moral damage caused by death – to spouse, parents, children, as well as persons who lived with the victim in the same family.
Damage caused by an employee (while performing work duties) is reimbursed by the employer, but the latter has the right to claim back. At the same time, in criminal proceedings, the damage can be recovered immediately from the doctor.
Transactional and competition issues
i Competition law
The competition law does not address any specific issues related to the life sciences sector. However, the law-enforcement practice of the AMCU is wide-ranging in this area. As regards the pharmaceuticals sector, the case law is mainly focused on pricing issues and distribution models (including selective distribution), misleading advertisement, confusingly similar naming and package designs. However, the Ukrainian competition authority has not yet looked into settlement of patent disputes or 'pay for delay' agreements.
The AMCU focuses a lot of its attention on:
- cooperation of pharmaceutical companies with the Ukrainian distributors and pharmacy chains while looking for signs of competition violations (anticompetitive vertical concerted actions or abuse of dominance) such as excessive pricing, establishing control over markets or market allocation;
- advertising of medicinal products; and
- distortion of results of public tenders.
From a practical point of view, the following business practices of pharmaceutical companies attract the AMCU's particular interest and entail respective allegations:
- granting discounts, compensations and bonuses without reasonable grounds;
- application of different terms and conditions to granting discounts, compensations and bonuses to different distributors;
- not taking all necessary measures to ensure that the discounts granted to the distributors or pharmacies are indeed transferred to the ultimate consumers;
- financing of a Ukrainian daughter company by a parent company as a result of granting discounts and bonuses;
- establishing such a business model of a group of companies, according to which only a Ukrainian daughter company of the international pharmaceutical company imports medicines of this group of companies into Ukraine;
- excessive reporting of distributors to pharmaceutical companies;
- any type of restrictions imposed on the export of medicines;
- applying significant discounts to a 'package proposal', which includes both: (1) top-priority medicines that do not have any substitutes in the Ukrainian market, as well as (2) other medicines having two or more substitutes. (The AMCU is of opinion that: (1) the prices for the top-priority medicines that do not have any substitutes are excessive at the very beginning and subsidise the rest of medicines, which have two or more substitutes and are included into this 'package'; and (2) applying significant discounts to such a 'package' is indeed a type of predatory pricing and drives the manufacturers of other cheap competing substitutes out of the Ukrainian market as well as creates barriers to entry for potential new competitors.); and
- allocation of certain distributors to particular tenders (i.e., providing certain distributors with special conditions or discounts for participating in particular tenders).
Moreover, as the practice shows, the AMCU compares: (1) prices of medicines supplied within public procurement procedures (i.e., in a public sector) with (2) prices of medicines supplied to pharmacies (in the private sector).
The AMCU is authorised to impose fines for competition violations, inter alia:
- in the amount of up to 10 per cent of the total income (revenue) of the company or a group of companies from the sale of products (works, services) for the last fiscal year preceding the year in which the fine is imposed, for:
- anticompetitive concerted actions,
- abuse of dominance; and
- in the amount of up to 5 per cent of the total income (revenue), for unfair competition.
Fines may be imposed by the AMCU on business entities irrespective of their place of residence. For instance, there has already been a case when a pharmaceutical company being a non-resident of Ukraine and a number of its Ukrainian distributors were fined for a total amount of approximately €57,000 for anticompetitive concerted practices related to pricing of medicines produced by a non-resident of Ukraine and sold in Ukraine.
ii Transactional issues
Transactions in the spheres of medicines and medical devices are subject to general provisions of Ukrainian antitrust and competition legislation. Incorporation of a joint venture, mergers and acquisitions are subject to clearance from the Antimonopoly Committee of Ukraine. Over the past three years there has been a significant increase of transactions on the pharmaceutical market of Ukraine, concerning both local and international companies.
Considering recent trends in Ukrainian draft legislation aiming to increase the role of local pharmaceutical companies on the Ukrainian market, we anticipate an increase of joint projects (co-marketing, co-promotion, contract manufacturing) between local and international players.
While the public private partnership (PPP) projects are currently at an early stage of development in the Ukrainian healthcare sector, the Ministry of Health is currently drafting a specialised legislation aimed at facilitation of PPP in the healthcare area, understanding the importance of active cooperation between the state and private investors, and another draft law aiming to regulate budgetary issues arising from PPP is being considered by the Ukrainian parliament.
Significant reform of industrial parks' regulation has taken place in 2021, and some of the local and international pharmaceutical companies aim to take advantage of the new regulations. The participants of the industrial park can carry out business activities in the processing industry, processing of industrial or household waste (except for waste burial), as well as scientific and technical activities, activities in the field of information and telecommunications under the conditions specified by the law and the agreement on business activities within the industrial park. There are several incentives for industrial park participants, such as full or partial compensation of the interest rate on loans for the arrangement or conduct of business activities within industrial parks, funds provided on a non-refundable basis for the arrangement of industrial parks or allowing the construction of related infrastructure, necessary for the establishment and functioning of industrial parks, compensation of expenses for connection to engineering and transport networks, tax and customs incentives.
Currently, Ukrainian legislation in the healthcare sphere is undergoing significant reform.
A draft law 'On Medicines' is expected to be adopted by the Ukrainian parliament in the first quarter of 2022. While the draft law is based on EU legislation on medicinal products for human use, the quality of the adaptation of the Ukrainian version is questionable.
The key areas that will be affected in case of adoption of the draft law are as follows:
- registration of medicinal products (cancellation of some of simplified registration procedures, marketing authorisation holders must be registered in Ukraine or in the EU or European Free Trade Association countries);
- importation of medicinal products (introduction of parallel import): the draft law provides that medicinal products may be imported in Ukraine not only by official distributors, but also by any legal entities having an import licence for medicinal products. Such a possibility of parallel import will only apply to the medicinal products allowed for use and distributed in the territory of the EU countries. Besides, it is provided that medicinal products imported via the mechanism of parallel import shall be identical or essentially similar to the ones registered in Ukraine (the criteria of similarity will be established by the Ministry of Health of Ukraine). Information regarding all the series of medicinal products imported into Ukraine through a parallel import mechanism shall be recorded in the special state registry. To import a medicinal product this way, an importer shall first notify an authorisation holder in the exporting state on the intention to engage in a parallel import. After a medicinal product has been imported in Ukraine, the importer is obliged to ensure pharmacovigilance as will be established by the legislation. The draft law lays down the information to be submitted to the regulatory authority by a parallel importer, yet additional regulations will be established by by-laws;
- trade in medicines and advertising (introduction of a nationwide system of identification of medicinal products, significant limitation of advertising of medicines); and
- all other aspects of medicinal products' circulation in Ukraine, as the draft law will cover all the aspects of a medicinal product's lifecycle from development to utilisation.
Active developments are seen also in the health technology assessment area, where a new procedure has been introduced in late 2020 that is currently being tested and adjusted by the newly created HTA department.
Regular developments in the public procurement and reimbursement of medicines are taking place and a new procedure for creating lists of products to be procured for the funds of the state budget is currently under public consideration and is expected to be adopted in early 2022.
Significant attention is paid to development of public–private partnership in the healthcare area, with a corresponding draft law currently being considered by the parliament.
Legislation concepts aiming to increase the role of local pharmaceutical companies on the Ukrainian market are currently under public consideration providing for incentives for localisation of manufacturing in Ukraine (e.g., more preferential treatment during public procurement procedures).
A draft law 'On Medical Devices' has been drafted by the Ministry of Health and is expected to be adopted in 2022. The draft law mostly aims to summarise legislative provisions that already exist in various legal acts concerning medical devices; however, important legislative provisions on clinical trials and on combatting falsified products are introduced for the first time.
New technical regulations harmonising with the EU Medical Device Regulation and the EU In-Vitro Diagnostic Medical Device Regulation are being developed by the Ministry of Health and are expected to be adopted in 2022 and to come into force in 2025 to 2026.
1 Lana Sinichkina is a partner, Mariia Baranovych is a senior associate, Yevgeniya Ocheretko is a counsel and Taras Kyslyy is a partner at Arzinger Law Firm.
2 Association Agreement between the European Union and its Member States (of the one part) and Ukraine (of the other part).
3 The Law of Ukraine On Medicinal Products.
4 Technical Regulations on medical devices, approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 2 October 2013 (as amended).
5 The Law of Ukraine On Fundamental Principles and Requirements to Safety and Quality of Food Products.
6 State sanitary rules and standards No. 2.2.9.027-99 'Sanitary rules and safety standards of products of the perfume and cosmetics industry'.
7 Resolution of the Cabinet of Ministers of Ukraine No. 376 dated 26 May 2005 'On approval of the procedure for state registration (re-registration) of medicines and the size of the fee for their state registration (re-registration)' (as amended).
8 The Order of the Ministry of Health No. 677 dated 29 September 2014 'On the approval of the procedure for quality control of medicines during wholesale and retail trade'.
9 Decree of the Cabinet of Ministers of Ukraine No 260 dated 3 February 2010 'Some Issues of Medicinal Products Quality State Control', which approved: (1) the procedure for conducting medicinal products' quality state control; and (2) the procedure for collecting samples of medicinal products to conduct laboratory analyses during the state quality control of such medicinal products.
10 Resolution of the Cabinet of Ministers dated 6 May 2000 No. 770 On Approval of the List of Narcotic Drugs, Psychotropic Substances and Precursors.
11 Resolution of the Cabinet of Ministers of Ukraine dated 7 April 2021 No. 324 On Amendments to the List of Narcotic Drugs, Psychotropic Substances and Precursors.