Svitlana Chepurna and Inesa Letych of Asters in Kyiv give us 10 things to know about pharmaceutical regulation
Increasing level of public health protection with simultaneous simplification of industry regulation appears to be the prevailing recent trend within the Ukrainian pharmaceutical market. In this regard, Ukraine has introduced a number of changes to thye relevant law resulting in reduced administrative burden and more efficient regulatory approaches. Another focus is streamlining of local pharmaceutical regulation with the internationally recognised standards, particularly with a view to boosting the country's international trade potential.
1. Pharmaceutical market players mostly deal with two regulators
These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices.
2. Medicines must pass state registration in the MOH to be marketed in Ukraine
This obligation applies equally to local and imported medicines (except for a limited number of cases, e.g., medicines produced at pharmacies). To certify state registration of a medicine, the MOH issues a registration certificate (marketing authorization) for a medicine that is valid for five years and is renewable upon application to the MOH.
3. Simplified registration procedure applies to medicines from countries with stringent regulatory policy
To be eligible for the simplified procedure, previous registration of a medicine in a country with a stringent regulatory policy for use within such a country is required. These countries include the United States, Switzerland, Japan, Australia, Canada, as well as the EU member states, provided, however, that a medicine was registered by the EU competent authority under the centralised procedure. The simplified procedure, among other things, contemplates reduced documentation requirements and timeframes for regulatory decisions.
4. Manufacturing of medicines must comply with GMP requirements
A manufacturer generally must obtain a GMP certificate from the SAUMP following inspection of relevant manufacturing site. The scope of Ukrainian procedures for GMP compliance evaluation is lesser for foreign manufacturing sites that have a document confirming GMP compliance (e.g., a GMP certificate or a license) from a competent authority of a PIC/S member country. Specifically, the SAUMP issues a GMP opinion that confirms a GMP document of a PIC/S regulatory authority to the manufacturing sites that hold such a document. Under a general rule, the SAUMP grants a GMP opinion based on review of submitted documents and without an onsite inspection.
5. Manufacturing and distribution of medicines in Ukraine is subject to licensing
Manufacturers and distributors of medicines must be licensed by the SAUMP to carry out any of these activities. A manufacturing license also authorises its holder to sell medicines to wholesale or retail traders. However, entities that purchase medicines from a manufacturer must hold a separate license for wholesale and/or retail trade in medicines.
Importantly, under Ukrainian law, each separate step of manufacturing process, including packaging, labelling and release of products, qualifies as manufacturing and requires a manufacturing license.
6. Import of medicines requires a relevant license, as well as compliance with certain other regulatory requirements
Ukrainian importers of medicines must hold an import license that is issued by the SAUMP in respect of specific medicines allowed for importation.
Also, as noted above, medicines may generally be imported to Ukraine provided that they are registered in Ukraine and that their manufacturing conditions comply with the GMP requirements, as evidenced by a relevant certificate or opinion. Furthermore, imported medicines must pass state quality control procedures and get an opinion on quality of imported medicines from local offices of the SAUMP.
7. Medical devices in Ukraine are regulated depending on their safety class
Medical devices may be sold or used in Ukraine provided that they have passed conformity assessment, as confirmed by a manufacturer's declaration or certificate issued by a competent organisation. The scope and procedures for such an assessment are determined pursuant to the safety class of a medical device and increase from Class I to Class III.
8. Prices for certain medicines and medical devices are subject to state regulation
Ukrainian law provides for maximum price mark-ups on wholesale purchase prices and retail prices of medicines that are included in (i) the National List of Essential Medicines that was approved based on the latest updated version of WHO Model List of Essential Medicines, or (ii) the mandatory minimum assortment of medicines for pharmacies and medical and obstetrical stations according to the MOH list.
Further, the law requires that the wholesale prices for medicines and certain types of medical devices that are purchased with state or municipal budget funds must be declared and recorded in the state register of wholesale prices. Medical institutions, which are partly or fully financed from state or municipal budgets, must purchase medicines and medical devices at the prices that do not exceed the registered wholesale prices increased by statutory defined mark-ups. Such institutions may not purchase medicines or medical devices that are not registered in the state register of wholesale prices.
9. Ukraine has special rules on advertising of medicines and medical devices to general public
Medicines and medical devices may not be advertised unless they are duly authorised for use in Ukraine. Further, the law prohibits advertising of prescription only medicines, as well as certain over-the-counter medicines according to the MOH list. The law also provides for other restrictions to be observed in advertising of medicines and medical devices, including the list of information, images, and references prohibited in an advertisement.
10. Reduced value added tax (VAT) rates or VAT exemptions apply to medicines and medical devices
The reduced 7% VAT rate (instead of the standard 20% rate) applies to transactions with medicines that have passed state registration, certain medical devices, as well as medicines and medical devices, which the MOH has permitted for use within clinical trials. Also, a temporary VAT exemption applies to certain transactions with medicines and medical devices performed in the course of state procurements or in connection with the anti-terrorist operation in Eastern Ukraine.