Market requirements for medicines
Medicinal products (medicines) – are substances or their combinations of nature, synthetic or biotechnological origin, that are used to prevent pregnancy, diagnose and healing human diseases or changing the condition and functions of the human organism.
Medicinal products include:
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active product ingredients (substances);
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finished medicinal products (medicinal products, medicines, medicaments);
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homeopathic products;
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products that are used to determine the sources of the diseases, and controlling sources of the diseases or parasites;
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medical cosmetics and medical supplements to food products;
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finished medicinal products (medicinal products, medicines, medicaments) – dosage medicinal products in that form and condition as it used;
From the end of 2010 immunobiological products (serums, vaccines and other products of biological origin) are included to medicines. Radiopharmaceuticals, narcotic products, homeopathic products and products for in-vivo diagnostics are considered as medicines.
Import, advertising, sale, medicinal use and marketing of medicinal products are allowed only state registration (marketing authorization) of the product. State registration of all types of medicines is performed by Ministry of Health of Ukraine, as a result of centralized expertise of safety, quality and efficiency of the product by State Expert Center of Ministry of Health of Ukraine. Procedure is initiated by submission of Application to State Expert Center and finished by issue of registration certificate and inclusion of the product to State Registry of Medicines.
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Certificate of state registration of medicinal product is valid for 5 years. Not later than 90 days before expiry of registration certificate Application for renewal of registration should be submitted.
Registration certificate consists of several documents:
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marketing authorization certificate of adopted form with registration number given in format UA/0123/01/01;
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annex to certificate - Control Methods of Quality of Finished Product (also called "AND") that includes detailed information on finished medicinal product, it's composition, specification, description of control methods, package and container closure system, storage conditions, shelf-life, approved primnary and secondary package drawings (mock-ups);
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annex to certificate - approved text of package insert (instruction for medical use of the product);
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annexes to certificates - all variations (changes) that have been applied to registration materials during validity of marketing authorization;
Information on registration of medicinal product is included to State Registry of Medicines of Ukraine.
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Regulatory system of Ukraine is based on EU legislation, but is not completely harmonized. Therefore Applicant can refer to the EU Guidelines as well as to local legal acts.
There is no mutual recognition procedure (MRP) since Ukraine is not a Member State. There is no any simplified registration process for products that have marketing authorization in EU, Russia, CIS or any other country.
Establishment of registration of medicinal product does not require Applicant to establish local office or any other type of legal entity. Applicant (owner of marketing authorization) can have any residence (manufacturer, any Ukrainian resident or non-resident can be Applicant).
Applicant is responsible for safety, quality and efficiency of medicinal products marketed in Ukraine, must establish and maintain
pharmacological vigilance system and will be contacted in issues related to quality of products.
All Applicant’s rights and responsibilities in regulatory affairs (interaction with state authorities during registration process), in quality issues (quality control during import) and pharmacovigilance issues can be transferred to the third party.
All registered medicines are free from VAT tax (20%).
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Cratia is commercial agency that offers all types of regulatory support: advisory and consulting, establishment of new registration, renewals, variations, pharmacological vigilance and maintenance of quality issues in Ukraine. We provide our knowledge and experience to many companies and have necessary capacities for new projects. |
On our website you can obtain more information about:
You can get in touch with us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting at our office.
