On 21 March 2023, the new Law of Ukraine On veterinary medicine (the Law) will come into force, subject to the transitional provisions detailed below. The Law aims to approximate Ukrainian veterinary legislation with EU directives and regulations as a part of the fulfilment of obligations under the EU-Ukraine Association Agreement.
The Law sets out a comprehensive regulatory framework in the field of veterinary medicine, animal health and wellbeing, veterinary practices, and the use of veterinary medicines. It defines the system of governance and functions of regulatory bodies, and the principles of development, approval, review and application of veterinary measures such as anti-epizootic measures, defining the criteria for inspections, testing, certification, etc.
In this article we discuss the main novelties of the Law concerning the circulation of the veterinary medicines.
Registration certificate (marketing authorisation) holder
Only legal entities (dossier-holders) incorporated in Ukraine can apply for and obtain registration certificates (marketing authorisation). If the dossier-holder is a foreign legal entity, it must appoint an official representative in Ukraine: either a local subsidiary or a contracted third party. If the foreign dossier-holder contracts a third party, the agreement must set out:
- the procedure and conditions for the transfer of the dossier for purpose of registration (authorisation);
- the liability of the official representative for disclosure or unauthorised use of the information in the dossier;
- the conditions and procedure for interactions between the parties following the authorisation of a veterinary medicine.
Within five years, the Law will permit the import and circulation of veterinary medicines authorised under the previous legislative framework. In addition, the renewal of veterinary medicines authorised before the Law’s entry into force will be possible by submitting additional data to comply with the new requirements of the Law.
Releasing and circulating veterinary medicines
Previously, only the manufacture of veterinary medicines was subject to licensing. The new Law establishes a licensing requirement for all activities related to the circulation of veterinary medicines: manufacturing, import, wholesale, and retail.
A manufacturing licence will be required for full-cycle manufacturing, as well as any manufacturing stage, including processing, assembling, packaging, repackaging, labelling, re-labelling, storage, sterilisation, testing, and batch release.
The import of veterinary medicines also requires a licence. Manufacturers and importers must engage a qualified person, either through employment or contracting.
The qualified person must ensure that each batch of veterinary medicines:
(a) (if manufactured in Ukraine) was manufactured in compliance with the GMP and verified by testing as required by the dossier
(b) (if imported into Ukraine) complete qualitative testing of all active ingredients and other control testing necessary to ensure the quality of veterinary medicines as required by the dossier
Detailed requirements for qualified persons will be established in subordinate legislation.
The manufacturing and import licences allow veterinary medicines to be sold to the holders of wholesale licences. In turn, a wholesale licence allows veterinary medicines to be sold to other wholesalers, as well as to retailers and veterinary practitioners/hospitals. A retail licence allows veterinary medicines to be sold to consumers.
Remote (online) sales of veterinary medicines
The Law permits licensed retailers to sell veterinary medicines remotely in accordance with e-commerce legislation. The remote sale of Rx medicines is prohibited. The Law provides for special requirements to be met by websites offering veterinary medicines for sale online.
Regulatory data exclusivity
The Law provides for the protection of the regulatory data contained in the dossier for novel veterinary medicines.
The marketing authorisation holder of a novel medicine enjoys exclusivity from 10 to 18 years, depending on the type of medicine:
(a) 10 years for veterinary medicinal products intended for cattle, sheep raised for meat, pigs, chickens, cats and dogs;
(b) 14 years for antimicrobial veterinary medical products intended for cattle, sheep raised for meat, pigs, chickens, dogs and cats, which contain antimicrobial active ingredients not used in previously authorised veterinary medicinal products;
(c) 18 years for veterinary medicinal products intended for bees;
(d) 14 years for veterinary medical products intended for other animal species.
Data exclusivity provisions are subject to a transition period: the exclusivity term for novel medicines submitted for authorisation during the first five years following the Law’s entry into force will be half of the terms stated above.
The Law establishes requirements to conduct clinical trials of veterinary medicines.
Any trial requires the approval of the State Service of Ukraine on Food Safety and Consumer Protection and is subject to compliance with VICH requirements in terms of planning, conducting, and documenting.
The Law establishes the following specific requirements regarding advertising veterinary medicines and medicated feeds:
(1) only authorised veterinary medicines can be advertised in Ukraine;
(2) advertising Rx medicines to the general public is prohibited. Advertising Rx veterinary medicines can only target:
(a) veterinary professionals;
(b) veterinary medicine market operators engaged in wholesale and retail, and
(c) operators of livestock facilities (only for immunobiological veterinary medicines, e.g. vaccines).
(3) sampling Rx medicines is prohibited. The Law permits the distribution of samples of OTC medicines with appropriate labelling:
(a) exclusively and directly to veterinary professionals during events sponsored by the distributor of such samples, or during visits by sales representatives, and
(b) in the quantity not exceeding one course of treatment specified in the leaflet.
The Law introduces a national system of veterinary pharmacovigilance to ensure the collection and analysis of data on adverse and unexpected reactions to veterinary medicines.
The marketing authorisation holder must set up a pharmacovigilance system and engage a qualified person. A description of the pharmacovigilance system must be provided as a part of the registration (marketing authorisation) dossier. The marketing authorisation holder must report on all adverse reactions by submitting the relevant data to the veterinary pharmacovigilance database.
Veterinary practitioners report to the competent authority and the marketing authorisation holders on all adverse reactions they detect.
Transition provisions and measures
The Law will come into force on 23 March 2023.
The designated regulatory body will define the timelines for the entry into force of GMP and GDP requirements, as well as requirements regarding retail practices.
The manufacturing licences issued under the previous legislation will be valid for one year following the Law’s entry into force. The licence holders may apply for the reissuance of licences during this first year free of charge.
For one year following the Law’s entry into force, obtaining import, wholesale and retail licences, as well as compliance with the respective licensing requirements, will be voluntary.
The international animal health industry operating in Ukraine views the adoption of the Law as a positive development. Following the full enactment of the Law, the regulatory framework of Ukraine in veterinary medicines will become compatible with the EU’s regulatory framework.
Currently, the Ukrainian government is developing subordinate legislation which is expected to be adopted by 23 March 2022.