In accordance with Decree of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376 medicinal products specified by the Article 2 of the Law of Ukraine "on Medicines" are allowed for use in Ukraine only after state registration (state marketing authorization).

Registration certificate is valid for 5 years from the moment of issue. Application for renewal of registration should be submitted not later than 90 days before registration will expire.

All registered medicinal products are free from VAT tax (20%). Custom duty for group 3004* is 0%.

Medicinal products (definition from the Law) – are substances or their combinations of natural, synthetical or biotechnological origin, that are used to prevent pregnancy, to precause, to diagnose and to heal human diseases or to change the condition and functions of the human organism.

Medicinal products include:

• active product ingredients (substances);

• finished medicinal products (medicinal products, medicines, medicaments);

• homeopathic products;

• products that are used to determine the sources of the diseases, and controlling sources of the diseases or parasites;

• medical cosmetics and medical supplements to food products;

• finished medicinal products (medicinal products, medicines, medicaments) – dosaged medicinal products in that form and condition as it used.

In the Legislation medicinal products are separated into several groups by its particularities:

• From the point of view of presence of the substance on the market of Ukraine medicinal products are classified as original and generic.

Definition of the original medicinal product is not provided in the legislation: all medicines are essentially considered as ”original”; for those medicinal products which complies to defined in the legislation terms ”similar medicinal product”, ”well-established use”, ”traditional herbal product” a special expert evaluation procedure can be applied.

To be considered as generic medicinal product it is required that medicine with the same composition, medicinal form and similar indications (so-called “reference product”) to be registered in Ukraine.

Original medicinal product includes “new combination of well-known components” and “extended medicinal use”.

• From the point of view of origin – medicinal products are classified as immunobiological products, homeopathic medicinal products, radiopharmaceutical medicinal product, herbal and/or mineral medicinal product and other medicinal products.

The term “other products” is not specified in the legislation, but this group is the biggest one since all “standard” chemical products are included to that group.

Healing cosmetics that contain particles of active substances is classified as medicinal product.

Registration procedure is regulated by many different orders, decrees and acts. Ukraine aims to harmonize it’s legislation step-by-step with legislation of European Union what cause serious changes every 2-3 months to the legislation.

There are many particularities during registration procedure of medicinal product, legislation environment changes often - for that reason there is a big demand of good regulatory specialists in Ukraine.

Cratia Ltd. offer the complete service list for outsourcing of the registration of medicinal products. Our specialist will perform on behalf of your company all required steps of registration procedure from A to Z, or can perfume some specific stages of the registration procedure.

Complete list of our service in registration of the medicines:

1. Preliminary preparation to the submission in Ukraine .

1.1. Consulting regarding list and specific requirements to the documents, required for State registration of the medicine in Ukraine ;

1.2. Preliminary control of the dossier to check the compliance with the legal requirements;

1.3. Correspondence with manufacturer/applicant to fulfill the missing documents;

1.4. Submission of the inquires for official scientific advice of the State Pharmacological Center of Ukraine (for example – scientific advice regarding generic/originality of the product);

1.5. Calculation of the budget and terms of registration;

1.6. Consulting regarding specific particularities of the registration procedure;

1.7. Development of the whole regulatory policy and regulatory strategy for Ukraine : terms, documentation, order of submission, maintenance of the variations etc.

State registration of medicinal products, medicines, pharmaceutical products in Ukraine. Marketing authorization of medications, remedies, pharma products. Regulatory affairs legislation of health and medical products. Ukraine, Kiev, Cratia Ltd. State registration of healthcare products, medicines, pharmaceuticals. Dossier on medicinal product (CTD format). State registration of vitamin, herbal, pharma, generic products in Ukraine. Ukraine, Kiev, Cratia Ltd.

2. Preparation (localization) of the dossier for registration of the medicine in Ukraine :

2.1. Professional medical translation of the required parts of the registration dossier;

2.2. Notary translation of the required document (Power of Attorney etc.);

2.3. Preparation of the Application for registration of the medicine in Ukraine ;

2.4. Preparation of the chemical-analytical normative documentation (so-called “AND”) in accordance with legal requirements;

2.5. Preparation of the technological normative documentation (so-called “TND”) in accordance with legal requirements;

2.6. Preparation (localization) of the PSUR ( Periodic Safety Usage Report ) for renewal of registration;

2.7. Preparation of the instruction for medicinal use and package leaflet;

2. 8. Preparation of the package information (text);

2.9. Preparation of the cover letters for submission to the SPhC of Ukraine;

2.10. Copying of the dossier;

2.11. Quality control of the entire dossier before submission to the State Pharmacological Center of Ukraine;

3. Submission and accompanying of the dossier in the State Pharmacological Center of Ukraine :

3.1. Submission of the Application for registration procedure;

3.2. 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;

3.3. If necessary – arranging the payments on behalf of the Applicant;

3.4. Submission of the three copies of the dossier to the State Pharmacological Center ;

3.5. Maintenance of the questions from the State Authorities that were asked during expertise of the dossier;

3.6. Calculating of the list of the samples of finished medicinal product, regents, active substances, reference standards that are required for quality assurance of the medicinal product;

3.7. Maintenance of the import approval of the required samples;

3.8. Control of the import procedure: preparation of the documents;

3.9. Custom clearance and delivery of the samples to the laboratory;

3.10. Receipt of the Invoice for the services of quality assurance of the sample of the medicinal product;

3.11. Control of the terms of the every State expertise procedure;

3.12. Informing of the Application regarding status of the registration procedure every specified period of time.

3. 13. Control and edition of the project (draft) of the registration certificate;

3.1 4. Receipt of the original registration certificate;

3.15. Delivery of the original registration certificate of the medicinal product to the Applicant;

Cratia Ltd. , in accordance with your needs, can perform as separate parts of the registration procedure as mentioned above (for example – medical translations, preparation of the dossier) as well as the entire process of the registration of the medicinal product in Ukraine .

In most cases our preliminary consulting services are free, please do not hesitate to contact us on issues of your interest.

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

• detailed information about 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;