State registration of BAA (about 2 months)
| Service | Detailed Description of Service | Price (EUR) one product name |
|
MA of BAA in Belarus
| Our services: Analysis of the composition with a report
Pre-submission activities ( preparation of submission parcel); submission; monitoring of evaluation process (deficiency letters, communication around on behalf of applicant, etc); approval | 100
|
| 500 | ||
| Contractor agrees to pay agreement for works with the republican unitary enterprise “Scientific practical center of hygiene” (testing of BAA) | 270-630 (depending upon the composition) | |
| Contractor agrees to pay agreement Republican for works with the center for hygiene, epidemiology and public health (examination of documents) | 270-315 | |
| Translation cost | 9-14 EUR/ per 1800 signs. | |
|
| State fee legislation
| 10-15 |
State registration (reregistration) and issue of the registration certificate on the medicinal product of foreign production (about 6 months)
| Service | Detailed Description of Service | Price (EUR) one product name |
| Our services:
| pre-submission activities ( preparation of submission parcel); submission; monitoring of evaluation process (deficiency letters, communication around on behalf of applicant, etc); approval | 1200-1800 (generic/original) |
| Translation cost |
| 9-14 EUR/ per 1800 signs |
| State registration (reregistration) and issue of the registration certificate on the medicinal product of foreign production
Ministry of Health (Centre of Expertise and Testing in Healthcare RUE) | Initial examination of documents | 150-160 |
| Specialized examination of documents Testing of Product | 1000-2500
600-1500 | |
| State fee legislation
| 110 | |
|
| Inspection of manufacturer, if necessary | 5000-8000 |
State registration (reregistration) and issue of the registration certificate on the medical devices (about 4 months)
| Service | Detailed Description of Service | Price (EUR) one product name |
| Our services:
| pre-submission activities ( preparation of submission parcel); submission; monitoring of evaluation process (deficiency letters, communication around on behalf of applicant, etc); approval | 1000-1300 |
| Translation cost |
| 9-14 EUR/ per 1800 signs |
| State registration on the medical devices of foreign production
Ministry of Health (Centre of Expertise and Testing in Healthcare RUE) | Initial examination of documents | About 350 |
| Specialized examination of documents Testing of Product | 500-950
300-350 | |
| State fee legislation
| 100 |
State registration on the pharmaceutical substance of foreign production (about 5 months)
| Service | Detailed Description of Service | Price (EUR) one product name |
| Our services:
| pre-submission activities ( preparation of submission parcel); submission; monitoring of evaluation process (deficiency letters, communication around on behalf of applicant, etc); approval | 1000-1350 |
| Translation cost |
| 9-14 EUR/ per 1800 signs |
| State registration on the pharmaceutical substance of foreign production
Ministry of Health (Centre of Expertise and Testing in Healthcare RUE) | Initial examination of documents | About 150 |
| Specialized examination of documents Testing of Product | About 1000
450-1350 | |
| State fee legislation
| 100 |
Introduction of changes into the registration dossier of the medicinal product (pharmaceutical substance) previously registered in the Republic of Belarus: (about 5 months)
| Service | Detailed Description of Service | Price (EUR) one product name |
| Our services:
| pre-submission activities ( preparation of submission parcel); submission; monitoring of evaluation process (deficiency letters, communication around on behalf of applicant, etc); approval | 450-800 |
| Translation cost |
| 9-14 EUR/ per 1800 signs |
| Introduction of changes into the registration dossier
Ministry of Health (Centre of Expertise and Testing in Healthcare RUE) | Initial examination of documents | 106-135 |
| Specialized examination of documents Testing of Product | 65-695
450-1350 | |
| State fee legislation
| - |