1. Scheme of the registration procedure in brief.

2. Detailed description of the registration procedure.

3. State fees.

4. List of the Cratia Ltd. services, terms and service fee.

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1. Scheme of the registration procedure in brief.

Step 1. After you decided to register products with our help - we sign the CDA (Confidentiality Agreement).

Step 2. You transfer the dossier(s) to our office, so we can perform the preliminary control of the documents.

Step 3. We carefully look through the dossier, prepare the list of missing documents and define the amount of work that have to be done.

Step 4. We announce the primary price and negotiate on discounts and terms of payment; if they are suitable for you - we start registration procedure, if not - we send you back all received documentation. First installment (25%) for services of Cratia Ltd.

Step 5. We perform the translation of the dossier, combine it in accordance with local requirements, prepare the missing documentation.

Step 6. We submit the Application and 3 copies of the final version of dossier to the State Pharmacological Center (SPhC) for expertise. SPhC issues the Invoices for State Fee and Expertise, we send them with invoices of Cratia Ltd. for second installment (50%).

Step 7. Each copy of the dossier is being transferred to specialized commissions. We do our best to speed up the adoption procedure.

Step 8. (simultaneously with step 7). Technological Normative documentation (TND) is being directed to the State Service of the med. products for adoption.

Step 9. (simultaneously with step 7). You send us the samples of the finished product plus standards if they are needed for quality assurance*.

Step 10. We submit the samples to the local laboratory for quality assurance.

Step 11. We answer on the comments of the SPhC if any.

Step 12. After adoption of TND, AND, leaflet and answers on the comments - dossier is being adopted on the session of the SPhC (each last Thursday of the month).

Step 13. After adoption of the product original registration certificate is being issued during 2 weeks.

Step 14. We send you the original registration certificate (market authorization), third installment (25%).

*Quality assurance - is the obligatory control procedure performed on samples to achieve compliance with methods from AND. For example - Appearance, Micro Biological purity etc.

2. Detailed description of the registration procedure.

2.1. Preliminary preparation for submission.

Before start of the registration procedure it is very important to decide the format of the dossier, composition of the dossier, budget of the registration procedure and other particularities.

Ukraine has two standards of the dossier that can be chosen by Applicant – CTD (same as in EU) and local “simple” format. Requirements of the “simple” format is becoming stricter every month and moving towards the CTD format. Procedure of registration (steps that should be done) does not depend on the format of the dossier.

Two types of medicinal product are used to be classified in Ukraine : original (active substance or indications are new for Ukraine ) and generic (active substance with same or alike indications was previously registered in Ukraine ). Term “generic” also covers medicinal products that are “well-established use” (more than 15 years), fixed combination (combination of well-known components that is slightly different from previously registered – for example vitamins).

Registration of generic requires only first two parts of the dossier in “simple” format (in other words clinical and preclinical studies are not required) in the case if Bioequivalence or Bioavailability studies are submitted. For injection forms some reduced preclinical and/or clinical studies are required. For local forms (gel, cream etc.) only serious expert reports are required.

Same situation is for CTD format in the case if product is generic: BE study plus expert reports (literature overview) on preclinical and clinical documentation are required.

Registration of original product will require full dossier that will contain detailed information on preclinical and clinical studies, same for “simple” and CTD format. Otherwise, if full dossier (incl. preclinical and clinical) for original product is not provided – product can be directed for clinical studies in Ukraine .

Depending on the chosen format of the dossier (CTD or “simple”) and classification (original or generic) the following procedure of the state registration will be maintained: require documents, form of the Application, sum of the State fees and other.

We offer to our potential customers free procedure of the preliminary conclusion to realize the possibilities and requirements. We need to receive from Applicant a composition of the medicinal product (Specification), indications for use (instruction of summary of product's characteristics) and information about country of origin.

Experts of Cratia Ltd. will perform the analysis of the received information (what can also include the scientific advice from the State Authority), afterwards – send you the preliminary conclusion.

To check the compliance of the dossier to the legal requirements we offer the procedure of the internal preliminary control of the dossier. After we sign the Confidentiality Agreement – you send us the dossier in paper or electronic form. Experts of our company carefully inspect the received documentation and make their comments regarding quality and quantity composition of the dossier (missing documents etc.). Procedure is free of charge.

2.2. Preparation (localization) of the dossier for submission.

After we have performed the internal preliminary control of the dossier and signed an Agreement – we start preparation of the dossier: translation of the necessary parts, preparation of the AND upon chemical-analytical part of the dossier, preparation of the TND upon description and validation of the manufacturing process, preparation of the instruction for medical use and package leaflet upon SmPC (Summary of product's characteristics) or CDS (core data sheet), preparation of the package text and so on.

During localization process many questions and comments are usually appear, that should be answered by applicant or manufacturer. Since we have the great experience in the registration of the medicinal products – we usually predict many of the questions that would be asked by experts from State Pharmacological Center .

Preparation of the dossier usually takes from 2 to 4 months, depending on the product.

We have implemented the double quality control system that minimizes any risks of the mistakes at the final version of the dossier.

We advice to submit the Application at least 2-3 weeks before the dossier will be ready for submission. Upon received Application State Pharmacological Center of Ukraine issues the official preliminary conclusion and Invoices for payment of the State Fees.

2.3. Submission and accompanying the dossier.

After payment of the State fees the dossier can be submitted to the State Pharmacological Center of Ukraine. Dossier for the finished medicinal product must be submitted in 3 copies that will be distributed between expert commissions.

During expertise of the dossier some questions that require respective answers can appear. The shorter term of the reply for such questions – the shorter term of the whole registration procedure. For that reason authorized person of Cratia Ltd. visit State Pharmacological Center almost daily.

Except documentary approval of the quality, safety and efficiency of the medicinal product – there is a procedure of the quality assurance (repeatability) of the control methods on the samples of the medicine: samples of the pharmaceutical product must be provided to the local authorized laboratory for conducting of the all quality methods applied in the AND (Specification). Specialists of Cratia Ltd . will receive the conclusion about quantity of the samples, reference standards and regents, apply for and receive the approval for import of the samples, assist manufacturer in preparation of the correct Proforma Invoice and perform the custom clearance of the package with samples.

After successful quality assurance, adoption of the AND, TND, intrusion for use and package leaflet, answers on all questions of the profile commissions – medicinal product is included to the log of the session of the State Pharmacological Center of Ukraine. Registration certificate will be issued during 15-20 days from the moment of the adoption on the session.

3. State fees.

All regulatory procedures in Ukraine must be charged in accordance with State tariffs. Regulatory procedures on medicinal products include three types of payments to the state authorities:

3.1. State fee to the Treasury of Ukraine is an obligatory payment during state registration or renewal of registration of medicinal products (variations/changes are not the object of that fee, except cases when the new package is introduced to the market).

State fee to the Treasury for registration of the new product is 100 EURO plus 10% for every additional dosage or package.

3.2. Payment for the expertise services by State Pharmacological Center of Ukraine is an obligatory payment for all regulatory procedures performed by State Pharmacological Center of Ukraine.

Registration of the original medicine, dossier is in CTD format – 3200 EURO;

Registration of the generic medicine, dossier is in CTD format – 2700 EURO;

Registration of the generic medicine, dossier is in “simple” format – 2050 EURO;

Registration of the fixed combination – 2700 EURO;

3.3. Payment for the services of State laboratory for quality assurance of samples should be paid during new registration of the medicinal products, or during some variations (mainly in the cases when changes were made to the chemical part of the dossier or quality of the product can be affected). Service fee of the laboratory is determined by internal pricelist of the chosen laboratory and can vary approximately from 800 to 2500 EURO.

4. List of the Cratia Ltd . services, terms and service fee.

4.1. We include the following list of works to our service of the new registration of the medicinal product:

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

•  submission of the preliminary letters (inquiries) to the State Authorities;

•  preparation of the Application and adoption of it with manufacturer/Applicant;

•  translation and preparation of the instruction and leaflet;

•  translation and preparation of the AND (Analytical Normative Documentation – list of control methods) and TND (Technical Normative Documentation – description of the manufacturing process);

•  preparation of the package mock-ups, editing the design;

•  combining the dossier in accordance with local standards and requirements;

•  copying of the dossier in 3 pieces (legal requirement);

•  submission of the dossier and Application to the State Pharmacological Center of Ukraine;

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

•  samples import management: approval for import, preparation of the documents, custom clearance and delivery to the laboratory;

•  World Courier (DHL, TNT, FedEx) expenses for delivery of the hard copies of documents;

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

4.2. Price of Cratia Ltd. service.

Registration of the generic medicinal product – starting from 3000 EURO;

Registration of the original medicinal product – starting from 4000 EURO;

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;

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.

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:

• commercial offer for 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;