Cancellation or refusal in marketing authorizationBased on the current wording of the Draft Law, the Ministry of Health of Ukraine (MOH) would be authorized to cancel or refuse a marketing authorization, if at least one stage of the manufacturing process is carried out by an entity having manufacturing facilities in Russia or Belarus.
Temporary cancellation of marketing authorizationThe MOH would also be authorized to “temporarily cancel” a marketing authorization, if its holder or holder’s representative in Ukraine is directly or indirectly related to an entity that:
- “Directly or indirectly” carries out manufacturing of pharmaceuticals in Russia or Belarus
- Is a representative, a representative office, licensee, marketing authorization holder, manufacturer or supplier of an entity listed in (i) above
- After 23 February 2022:
- Performed obligations in taking part in at least one stage of manufacturing a pharmaceutical or an active pharmaceutical ingredient (API) in Russia or Belarus
- Provided, licensed out, rented out or sold directly or indirectly “pharmaceutical tangible or intangible assets” or related patents, authorizations, licenses, marketing authorizations, rights and other documents required for the manufacturing of pharmaceuticals and APIs to a Russian or Belarusian resident.
Issues to be further clarifiedThere are still many issues around the provisions of the Draft Law, including the following:
- The criteria to determine which specific marketing authorizations of a certain marketing authorization holder would be temporarily cancelled
- How the relation to an entity with ties to pharmaceutical manufacturing in Russia or Belarus would be determined
- The mechanism of temporary cancellation and the subsequent renewal of a marketing authorization
- The meaning of terms “indirect manufacturing of pharmaceuticals” and “pharmaceutical tangible or intangible assets”