Implementing changes to the registration certificate of the medicinal product:

1. Types of changes.

2. State fees.

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

Variations to the registration certificate is the change or extension of the previously adopted information, for example: change of the package design, change of the text of the instruction for use or package leaflet, change of the Applicant (sale of the registration certificate), changes to the description of the manufacturing process etc.

1. Types of changes.

There are two following types of changes are defined in accordance with legislation:

Type I changes (IA or IB) – minor changes that do not require specialized expertise.

That type of changes include minor changes to the package design, text of the instruction/product leaflet, change of the address of the manufacturer, change of the name of the medicinal product, change of the ATC code, minor changes in the manufacturing process of the active substance and change of the manufacturer of the active substance, change of the excipient to analogue, change or extension of the flavor etc.

Type II changes – major changes that cannot be considered as minor or an extension of use as well as do not relate to transfer of the registration certificate to another Applicant.

Type II changes include “urgent safety restrictions”: temporary changes caused by the receipt of new information regarding safety of the product; information about changes to the following points of the instruction for medical use: indications, dosage, contraindications, warnings, withdrawal period.

Implementing changes type I and II is possible during renewal procedure.

All other variations that cause serious changes of the characteristics of medicinal product – lead to the new registration .

Such variations include : inclusion/exclusion of the active substance, changes of the quantity of active substance(s), inclusion/exclusion of the therapeutic indications, changes of the bioavailability, pharmacokinetics, dosage, changes or inclusion of the new medicinal form, method of use.

There is also exist a technical changes procedure. Technical changes – is a correction of the mistake that appeared during translation and preparation of the registration dossier, if correct information is mentioned in initial documents.

2. State fees.

Variations to the registration certificate (marketing authorization) is only charged by sum of the expertise of the State Pharmacological Center of Ukraine, and in some cases (type II changes) – services of the laboratory for quality assurance.

Fee for the expertise of the variation documentation by SPhC of Ukraine:

Technical changes – 40 EURO;

Changes type IA – 80 EURO;

Changes type IB – 160 EURO;

Changes type II – 480 EURO;

Changes that cause new registration – 1000 EURO;

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

Our service fee depends on the specific of the variation procedure, complicity and scope of works, terms and other factors. For every separate case we calculate the expenses and provide separate offer, but our average service fee is:

Technical changes – 200 EURO;

Changes type IA – 400 EURO;

Changes type IB – 500 EURO;

Changes type II – 600 EURO;

Changes that cause new registration – 2500 EURO (in the case if product was previously registered by Cratia Ltd. – we provide additional discount 30-50%).

Average term to implement technical changes – less than 30 days , changes type I – approximately 30 days, changes type II – from 30 days, and changes that cause new registration – from 90 days.

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

• commercial offer for registration of the medicinal product;
• detailed information about renewal of registration of medicinal product;
• contact us;