Medicinal Products registration procedure in Ukraine

Procedure

1

We evaluate given materials, create the list of required documents, define the scope of works.

2

Preparation of the Application for registration of the medicine in Ukraine

2.1

Preparation of the Technological Documentation (TND)

2.2

Preparation of the cover letters for submission in the SPC (State Pharmacological Centre) of Ukraine

3

Filing of on Application in the State Pharmacological Centre

4

Primary expertise of the Application

4.1

Receipt of the Invoices for the state fee to the Treasury of Ukraine and state fee for expertise of the State Pharmacological Center of Ukraine

5

Invoice payment

6

Adaptation of the dossier according to the order № 426 (copy, page numbering, request the missing material)

6.1

Translation of the instruction for medical use

6.2

Translation of the chemical-analytical normative documentation

6.3

Professional medical translation of the required parts of the registration dossier

6.4

Preparation project of the instruction for medical use

6.5

Preparation of the chemical-analytical normative documentation

7

Control of the procedure customs: preparation of the documents

7.1

Receipt of the letter on a one-time Import of samples in the State Pharmacological Center of Ukraine

7.2

Custom clearance of the samples

8

Contract with the laboratory

9

Delivery of the samples to the laboratory

9.1

Payment for laboratory services

10

We, under Your approval, are answering all arising State Pharmacological Center of Ukraine, authorized laboratory or State Service remarks and questions; conducting work with State Pharmacological Center experts.

11

Artworks on the box & blister

11.1

Correcting box & blister (Brille)

12

Work with experts (statement of analytical documentation)

13

Approved by Order of The Ministry of Health of Ukraine

14

Obtaining certificate of registration

 
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