Prospective entry into the market of the Eurasian Economic Union (EAEU) of foreign medicinal products registered according to the national procedures of the EAEU States were discussed by the Member of the Board – Minister in charge of Technical Regulation of the Eurasian Economic Commission (EEC) Viktor Nazarenko and the Deputy Minister of Public Health of the Republic of Cuba, Dr. Marcia Cobas Ruiz on September 18 at the EEC venue.
In opening the meeting Viktor Nazarenko highlighted:
“Cuba has long-established contacts with all the Union States both in the sphere of drug circulation and on the issue of interaction in the field of public health and arrangement for medical assistance. It legitimately holds one of the dominant positions among the Caribbean countries being the largest pharmaceutical manufacturer of vaccines and biological medicinal products”.
It was noted that pursuant to the EAEU legislation continued circulation at the Union’s market of foreign drugs that have already been registered according to the national procedures including drugs of the Republic of Cuba is possible solely in case of compliance with the three main conditions. Firstly, a foreign manufacturer must execute the documents of drug master file in the format of the common technical document. Secondly, the drug master file must include the results of clinical studies held in the ICH Member States before January 1, 2016.
At least one clinical study out of those held after the stated date shall be fully or partially held on the Union’s territory. Thirdly, the manufacturer should submit the documents on passing by foreign manufacturing platforms of the inspection for compliance with national GMP rules of the Union States prior to December 31, 2020 or EAEU GMP – after such date. Foreign manufacturers must adapt drug master files to requirements of the Union’s legislation before the end of 2025.
The EEC Minister brought up the issue of entry into the pharmaceutical market of the Republic of Cuba of drugs of the manufacturers in the Union countries which face problems upon registration of medicinal products and their subsequent inclusion in the list of importers of MediCuba company which is one of the main conditions of entry of drugs into the Cuban market. Marcia Cobas Ruiz declared her country’s readiness to render any necessary assistance to the manufacturers of the EAEU countries as well as to address the issue of expediency of entering into a memorandum in the sphere of drug circulation between the Republic of Cuba and the EEC.