State registration (reregistration) and issue of the registration certificate on the medical devices and medical equipment of foreign production

 1) a notarized copy of the document about the registration of the medicinal product in the country of producer (applicant) (registration certificate for the free sale or the certificate of the pharmaceutical product) the remaining term of validity of which should be not less than 6 months for the state registration (reregistration) and 3 months – for the state registration of the medicinal product intended for the treatment of limited groups of patients with a low-frequency abnormality;

2) a notarized copy of the document of the producer giving an authorization for the production of the medicinal product on the basis of the license;

3) a notarized copy of the license or the document certifying the production of the medicinal product in the conditions of the Good Manufacturing Practice, the remaining term of validity of which should be not less than 6 months for the state registration (reregistration) and 3 months – for the state registration of the medicinal product intended for the treatment of limited groups of patients with a low-frequency abnormality. In case of absence of information in these documents about the date of performance of the last inspection of the mentioned production the term of validity of these documents shall be considered not more than 3 years from the date of their issue;

4) draft instruction on the application of the medicinal product and (or) the package leaflet;

5) the document of the producer including the data about the content of the medicinal product with indication of the number of all ingredients, including additives, coloring materials, flavouring materials, stabilizators and other components for one pharmaceutical form with the reference to the normative document on the control over their quality (monographs or pharmacopeia monographs of the pharmacopeia, the normative documents of the producer on the quality control of the medicinal product or the additive);

6) the document of the producer including the description of methods of production of the medicinal product, the control of quality of intermediate products, the brief scheme of production, the volume of the industrial series, data about the validation of the industrial process or the plan of the performance of validation – at the registration of the medicinal product;

7) the normative document of the producer containing the parameters and methods of quality control of the medicinal product;

8) the normative document containing the parameters and methods of quality control of pharmaceutical substances and additives – at the registration of the medicinal product;

9) copies of the report certified by the applicant (the applicant) on the validation of the methods of quality control of the medicinal product - at the registration of the medicinal product;

10) the document of the producer confirming the quality of one lot of pharmaceutical substance and the medicinal product;

11) the design of packaging with marking in the Belarusian and the Russian languages;

12) the document of the producer containing the results of study of the stability of two lots of the medicinal product (the plan, the report, tables with the results of studies) - at the registration of the medicinal product;

13) a copy of the report certified by the applicant (the producer) about the study of bioavailability (bioequivalence) of generic medicinal products (if any) - at the registration of the medicinal product;

14) the declaration of the producer certified by the applicant (producer)containing the data on the assessment of risk for the environment in respect of the medicinal product which contain genetically modified components - at the registration of the medicinal product;

15) a copy of the report certified by the applicant (producer) about the preclinical trial of the medicinal product (except for generic medicinal products including pharmacotoxical trilas in accordance with the Good laboratory practice) - at the registration of the medicinal product;

16) a copy of the report certified by the applicant (the producer) on the performed clinical trial of the medicinal product in accordance with the Good clinical practice – at the registration of the medicinal product (except for generic medicinal products in case the report on the investigation of bioequivalence has been presented);

17) information about the experience of application of the medicinal product (research articles, monographs, publications, clinical protocols, procedure manuals;

18) a copy of the report certified by the applicant (producer) on the safety of application of this medicinal product of this producer for the last 5 years – at the registration and reregistration of the medicinal product in case of expiration of the term of validity of the registration dossier.