If necessary, the authorized bodies of the EAEU states will be able to register medicines that have already undergone the relevant procedure in other member countries of the union, without the participation of pharmaceutical manufacturers. This will be possible if there are no analogues of the drugs on the given market and if there is a written consent of the holder of the registration certificate.
Authorized bodies of the EAEU states have been given the opportunity to register, on their own initiative (without the participation of pharmaceutical manufacturers), drugs that have already undergone this procedure of entering the market in other member countries of the union. This is allowed if there are no analogues on the state market and if there is a corresponding need. The innovation is enshrined in the decision of the Council of the Eurasian Economic Commission (EEC) No. 117, approved in November last year and published on January 13 on the EEC website.
Registration will be carried out without payment of a fee based on the results of an examination carried out in the reference state.
The term of the procedure for registration of a medicinal product at the initiative of the authorized body should not exceed 40 working days from the date of receipt of the written consent of the holder of the registration certificate until the date of issuance of the registration certificate. At the same time, the validity period of the registration certificate in some cases may be shorter than that established by the reference state.
"The Association of Pharmaceutical Manufacturers of the EAEU considers the amendments to the Rules for Registration of Medicines in the EAEU to be important and in the interests of patients, since they establish a procedure for recognizing the registration of a medicinal product not only at the initiative of the applicant, but also at the initiative of the authorized body," said Alexey Kedrin, Chairman of the Board of the APhEAEU. "This procedure concerns special cases of registration, such as the introduction of medicines to small markets of EAEU member states that have less commercial appeal for the pharmaceutical manufacturer, in connection with which the manufacturer may not submit such medicines for registration in this state of the union first. At the same time, medicines are necessary for the healthcare system, since they are used, albeit in small volumes, to provide emergency types of medical care."
According to him, the changes made to the registration rules make it possible to avoid shortages of medicines, which in turn will have a positive impact on ensuring the availability of medicines for patients in the EAEU countries.
The document comes into force after 30 calendar days from the date of its official publication.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
Authorized bodies of the EAEU states have been given the opportunity to register, on their own initiative (without the participation of pharmaceutical manufacturers), drugs that have already undergone this procedure of entering the market in other member countries of the union. This is allowed if there are no analogues on the state market and if there is a corresponding need. The innovation is enshrined in the decision of the Council of the Eurasian Economic Commission (EEC) No. 117, approved in November last year and published on January 13 on the EEC website.
Registration will be carried out without payment of a fee based on the results of an examination carried out in the reference state.
The term of the procedure for registration of a medicinal product at the initiative of the authorized body should not exceed 40 working days from the date of receipt of the written consent of the holder of the registration certificate until the date of issuance of the registration certificate. At the same time, the validity period of the registration certificate in some cases may be shorter than that established by the reference state.
"The Association of Pharmaceutical Manufacturers of the EAEU considers the amendments to the Rules for Registration of Medicines in the EAEU to be important and in the interests of patients, since they establish a procedure for recognizing the registration of a medicinal product not only at the initiative of the applicant, but also at the initiative of the authorized body," said Alexey Kedrin, Chairman of the Board of the APhEAEU. "This procedure concerns special cases of registration, such as the introduction of medicines to small markets of EAEU member states that have less commercial appeal for the pharmaceutical manufacturer, in connection with which the manufacturer may not submit such medicines for registration in this state of the union first. At the same time, medicines are necessary for the healthcare system, since they are used, albeit in small volumes, to provide emergency types of medical care."
According to him, the changes made to the registration rules make it possible to avoid shortages of medicines, which in turn will have a positive impact on ensuring the availability of medicines for patients in the EAEU countries.
The document comes into force after 30 calendar days from the date of its official publication.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
