The national market of medicines is gradually moving to the single circulation market of the Eurasian Economic Union. According to Decision 78 on the “Rules for Registration and Examination of Medicines for Medical Use”, all medicines registered in accordance with the legislation of Member States of the new EAEU should be brought into line with the requirements of international treaties and acts constituting the law of the Union by December 31, 2025.

In Russia, the authorized body accepting applications for re-registration is the Ministry of Health of the Russian Federation. In general, the procedure for reviewing the registration file is as follows:

1.The applicant shall submit an application to the authorized body of the reference state.

For reference:

Reference State is a Member State, preparing an expert report on the assessment of the safety, efficacy and quality of the medicinal product based on the expert examination of the medicinal product in accordance with these Regulations;

2.The authorized body of the reference state provides information to the authorized bodies of other Member States, as well as to the Commission and within 5 working days upon request of expert organizations of state bodies of recognition provides a registration dossier in electronic form.

3.On the basis of the results of the registration of the medicinal product (MP) the authorized body of each Member State that has registered the MP issues the RU of the MP, confirming the fact of its registration. RU for MP is issued in a uniform form.

The validity period of the RU for the first registered medicinal product in the reference state is 5 years.

Then it is necessary to pass the procedure of re-registration, on the results of which an indefinite RU is issued.

For some drugs there is a simplified system of transition to the common circulation market. Thus, medicines registered in accordance with the legislation of the Member States until December 31, 2020, and circulating for 5 years or more on the market of at least three Member States may to get the procedure of bringing it into line with the requirements of the Union. Thus, the RU for such drugs will become perpetual.

How much do the procedures for the registration of MP within the EAEU cost?

1) for the examination of a medicinal product for medical use at its registration – 325 000 rubles;

2) for the assessment of the expert report on the assessment of the safety, efficacy and quality of the medicinal product for medical use – 325 000 rubles;

3) for the examination of a drug with a well-studied medical application at its registration – 45 000 rubles;

4) for the assessment of the expert report on the assessment of the safety, efficacy and quality of a drug with well-studied medical use at its registration – 45 000 rubles;

5) for confirmation of registration of a medicinal product for medical use – 145 000 rubles;

6) for making changes in the documents contained in the registration dossier of the registered medicinal product for medical use, changes requiring examination of the medicinal product and for medical use – 75,000 rubles;

7) for making changes in the documents contained in the registration dossier of the registered medicinal product for medical use, which do not require the examination of the medicinal product – 5,000 RUB;

8) for bringing the registration dossier of the medicinal product for medical use in accordance with the requirements of the Eurasian Economic Union – 75 000 rubles;

9) for issuing the registration certificate of a medicinal product for medical use – 10 000 rubles;

10) for issuing a duplicate of the registration certificate of a medicinal product for medical use – 2,000 rubles.

It is worth noting that the legislative base for the transition to the EAEU market is still at the stage of formation. The issues of harmonization of requirements for the registration dossier, as well as the procedure for mutual recognition, remain unclear. According to the newspaper “Pharmaceutical Bulletin”, only one drug was registered in the framework of EAEU. Registration certificate was received in Kazakhstan by GlaxoSmithKline (GSK) and did not go through the mutual recognition procedure in the rest of the EAEU member states.

However, confirmation of this information has not been found in the register of medicines of the EAEU.

References:

1. Решение Совета Евразийской экономической комиссии от 03.11.2016 N 78 (ред. от 14.06.2018) “О Правилах регистрации и экспертизы лекарственных средств для медицинского применения”
2. НК РФ Статья 333.32.1. Размеры государственной пошлины за совершение действий уполномоченным федеральным органом исполнительной власти при осуществлении государственной регистрации лекарственных препаратов и регистрации лекарственных препаратов для медицинского применения в целях формирования общего рынка лекарственных средств в рамках Евразийского экономического союза
3. https://pharmvestnik.ru/content/news/GSK-pervaya-zaregistrirovala-lekarstvo-v-ramkah-EAES-v-Kazahstane.html
4. https://portal.eaeunion.org/sites/odata/_layouts/15/registry/pmm01/tableview.aspx?filter=%7B”KeyWordsCertificate”%3A””%2C”KeyWordsApplication”%3A””%2C”KeyWordsSubstance”%3A””%2C”KeyWordsStatement”%3A””%2C”DosageFormCodes”%3A%5B%5D%2C”InternationalNonProprietaryCodes”%3A%5B%5D%2C”GroupChemicalDrugCodes”%3A%5B%5D%2C”HomeophathicMaterialCodes”%3A%5B%5D%2C”PlantMaterialCodes”%3A%5B%5D%2C”ManufacturingCountryCodes”%3A%5B%5D%2C”OrphanDrugCountryCode”%3A%5B%5D%2C”ControlListCountryCode”%3A%5B%5D%2C”RegistrationDrugKindCode”%3A%5B”01″%2C”02″%2C”03″%2C”04″%2C”05″%2C”06″%2C”07″%5D%2C”DrugAdditionalFeatureCode”%3A%5B%5D%2C”RegistrationStatusCodes”%3A%5B%5D%2C”RegistrationCountry”%3A%5B%5D%2C”PlantMaterialCode”%3A%5B%5D%2C”ActiveIngredientCountryCode”%3A%5B%5D%2C”InternationalNonProprietary”%3A%5B%5D%2C”RecognitionUnifiedCountryCode”%3A%5B%5D%2C”DrugCountryRegistration”%3A%5B%5D%2C”ApplicationStatusCode”%3A%5B%5D%2C”DrugApplicationKindCodeType”%3A%5B”01″%2C”02″%2C”03″%2C”04″%2C”05″%2C”06″%5D%7D

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