1. Particularities and description of the re-registration of medicines in Ukraine .

2. State obligatory fees.

3. List of services of Cratia Ltd. and service fee.

Registration certificate (marketing authorization), in accordance with legislation of Ukraine , is valid for 5 (five) years. To renew the validity of the registration certificate and prolong it for the next 5 years – a renewal procedure must be performed.

Renewal procedure is simplified in compare with new registration procedure .

1. Particularities and description of the re-registration of medicines in Ukraine .

List of the required documents for renewal of registration do not include the preclinical and clinical parts of the dossier except PSUR (periodic safety usage report).

Quality assurance is not required*. That means that during renewal of registration there is no need to import the samples of the medicinal product to Ukraine .

Accordingly – there is no fee for the laboratory expertise.

Submission of the Application for re-registration must be done not later than 90 days before expiry of the valid registration certificate. In the case if registration certificate will expire before issue of the new registration certificate – product must be withdrawn from the sales**.

Total size of the State fees is much smaller than for new registration.

* Only in the case if there were no changes to the chemical-analytical part of the dossier.

** Such situation can be solved, please contact us for details.

Average term to renew the registration – from 6 to 9 months.

Average term to renew the registration with assistance of Cratia Ltd. – less than 4 months.

2. State obligatory fees .

During renewal of registration there are two obligatory payments to the state authorities:

2.1. State fee to the Treasury of Ukraine, is paid after submission of the Application for renewal of registration and before expertise of the dossier, sum is 100 EURO for renewal of registration of one medicinal product plus 10% for every additional dosage or/and package.

2.2. Fee for the expertise performed by State Pharmacological Center of Ukraine is paid after submission of the Application and before expertise of the dossier, sum is 1300 EURO for renewal of registration of one medicinal product plus 10% for every additional dosage or/and package.

3. List of services of Cratia Ltd. and service fee.

3.1. For renewal of registration of medicinal product the following list o services will be performed (in brief):

• translation of the required parts of the dossier, notary translation;

• preparation of the Application, preparation of the PSUR;

• update of the instruction, leaflet, AND, package design;

• preparation of the dossier in accordance with requirements of legislation;

• copying of the dossier (3 copies);

• submission of the Application to the State Pharmacological Center ;

• submission of the dossier to the State Pharmacological Center ;

• accompanying the dossier during expertise in profile commissions, defending the interests of the Applicant;

• expenses for World Courier services;

• all other expenses; service fee defrays all charges required for renewal of registration except State fees;

Detailed list of services for renewal of registration you can find here.

3.2. Service fee of Cratia Ltd:

Renewal of registration of one medicinal product – from 2300 to 3500 EURO plus 10% for every additional dosage and/or package.

Service fee depend on:

• language of the dossier and quantity of the documents for translation;
• quality and quantity composition of the dossier;
• country of origin (we provide discounts for manufacturers from PIC/S);
• quantity of the products that we have simultaneously received for registration;

If you are interested in services of our company in the field of renewal of registration of medicinal products, you can also find at our website:

•  dossier structure for renewal of registration;

•  commercial offer for renewal of registration of the medicinal product;

•  detailed information about renewal of registration of medicinal product;

•  detailed information about implementing changes (variations) to the registration certificate;

•  contact us;

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