Ukraine has introduced the procedure for emergency-use authorisation for COVID-19 vaccines and biologics, which de facto constitutes recognition of the reference authorisation granted by the regulatory authorities of the EU, WHO and selected countries (mainly, key stringent regulatory authorities, as well as India and China).
The procedure permits authorisation without localising the packaging and labelling.
No COVID-19 vaccines were eligible for a regular marketing authorisation procedure until 29 January 2021 when the Ukrainian parliament urgently introduced emergency-use authorisation to the legislation. On 8 February 2021, Ukraine's Cabinet of Ministers passed Resolution No. 95, which adopted the detailed procedure.
As a result, emergency-use authorisation may be granted in Ukraine in the following circumstances:
- there is data on successful completion of preclinical trials, individual phases of clinical trials; and
- either the authorisation for emergency use (conditional marketing authorisation or analogue) of a COVID-19 vaccine or biologic has been granted by the competent regulatory authority of the US, UK, Switzerland, Japan, Australia, Canada, China or India, or under the EU centralised procedure, or the vaccine or biologic has been pre-qualified by the WHO.
The following documents must be submitted to obtain emergency-use authorisation:
- confirmation of granting emergency-use authorisation (conditional marketing authorisation or analogue) by any of the reference regulatory authorities;
- assessment report, risk management plan, and leaflet and product summary issued or approved by the reference regulatory authority, but only if available under the reference authorisation procedure;
- layout of packaging and labelling details;
- Ukrainian translation of the labelling, packaging, leaflet and summary of product characteristics;
- written obligation from the manufacturer to produce the product at the same facilities where the product is produced for the country of the reference authorisation;
- GMP certificate issued (or recognised) by the Ukrainian Quality Inspectorate, or an Ukrainian Quality Inspectorate decision on recognition of GMP inspection of the manufacturing facility conducted by the domestic inspectorate in the manufacturing country. The procedure for recognition of GMP inspection of the manufacturing facility was adopted in Ministry of Health Decree No. 227 (10 February 2021).
Due to the urgency in adopting the amendments, there is an ambiguous provision in the law on the dossier submission and assessment. The law clearly provides for the recognition of the reference authorisation without assessment of the dossier. However, the local regulatory authority is expected to conduct the risk-benefit assessment. Resolution No. 95 indicates that the applicant may submit the dossier (or the available part of it), but is not obliged to do so.
Provided that the required documents are in place, the decision-making process will be fast – five to ten days following the date of submission. As of this writing, two COVID-19 vaccines (i.e. Pfizer-BioNTech COMIRNATY and Oxford/AstraZeneca licensed and Serum Institute of India manufactured COVISHIELD) were granted emergency-use authorisations within one week following the submissions.
The authorisation is issued for a period of one year and may be extended annually for another year. The total period of authorisation may not exceed the reference authorisation.
Because our CMS team contributed to development of the legislative amendments and the regulatory procedure adopted by the government, we can be consulted directly for more information. Please contact your regular CMS client partner or local CMS expert: Borys Danevych.