Re-registration of medical products and pharmaceutical substances
Pursuant to the current Ukrainian legislation the period of validity of registration certificate for medical product is 5 years, after this period re-registration is needed.
Thus, timely and successful passing of re-registration procedure provides unlimited validity of registration certificate.
We offer our clients full maintenance of the procedure of re-registration of medical product or pharmaceutical substance.
The process includes the following stages:
| 1st stage | Primary consultation of the client on procedure (if necessary). |
| 2nd stage | Pre-expertise of the clients’ document package. |
| 3rd stage | Concordance of terms and conditions of re-registration procedure. |
| 4th stage | Execution/presentation of the offer for re-registration to MH of Ukraine. |
| 5th stage | Execution/presentation of micro file for medical product to SEC. |
| 6th stage | Maintenance of state expertise of the file in the committees. |
| 7th stage | Payment of bills (SEC expertise services+ governmental charge). |
| 8th stage | Preparation for presentation/presentation of registration file. |
| 9th stage | Maintenance of state expertise of the file in the committees. Development of expert’s remarks. |
| 10th stage | Meeting at SEC on the matter of medical product re-registration. |
| 11th stage | Receipt/reading of re-registration documents project. |
| 12th stage | The order of MH on medical product re-registration. |
| 13th stage | Receipt of the originals of registration documents. |
Please, contact us and we’ll help you to save your time and budgets for new opportunities.