Registration of medicines products in Ukraine

Production of pharmaceutical companies is a special part of modern industry. Pharmaceutical products include all medications, obtained by synthesis or by biotechnology, which affect the physiological functions of the organism and used for the prevention and treatment of various diseases. For the medicines manufacture used a range of active substances both natural and synthetic in origin. Medical products also include disinfectants, curative cosmetics, a variety of medical supplements and herbal treatments.

Special categories of medicines:

• Immunobiological – vaccines, toxoids, immunoglobulins, sera, bacteriophages, interferons, bacterial preparations.
• Herbal preparations – preparations, obtained through processing of herbal substances, by: extraction, distillation, extraction, fractionation, purification, concentration, fermentation.
• Homeopathic medicine – or any medicinal product, manufactured from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure.
• Ready for use radiopharmaceutical – contains one or more radionuclides (radioactive isotopes) included for medical purpose.

Every pharmacological product must pass the full range of clinical and preclinical trials in the prescribed manner and obtain a licence issued by authorised body.

In the CIS is used the classification of drugs according to their pharmacological effects on the human body or medical purpose. In international practice there is a so-called ATC Classification (Anatomical Therapeutic Chemical), which divides drugs into groups according to the indications for their use.

Manufacture of medicines must comply with the legislation of the country where they are made, and the goal is to enter the world market it has to comply with international requirements of GMP (Good Manufacturing Practice). This system of rules, regulations and guidelines has been developed specifically for the manufacture of medicines, medical equipment, diagnostic devices, as well as food and a variety of food and dietary supplements. GMP standard aims to evaluate and adjust parameters of the medicines production and guarantees the quality of laboratory testing.

Re-registration of medical products

1. Features and the description of a re-registration of medicines in Ukraine
2. The list and cost of company services Alenpharm

Re-registration (registration prolongation):

The registration certificate, according to the current legislation of Ukraine, is valid throughout 5 (five) years. To renew the certificate on the following of 5 years, it is necessary to undergo procedure of a re-registration of a medical product.

The given procedure is rather similar to GLS registration, but is slightly simplified.

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

Rough term for re-registration passage – from 6 till 9 months.

Rough term for passage of a re-registration under condition of our help – about 4 months.

Obligatory state payments are reduced.

Filing of application on a re-registration should pass not later than 90 days prior to the termination of action of the current registration certificate. In case of the termination of action of the certificate before reception of the certificate on a re-registration – the product should be withdrawn from turnover*.

The list of necessary documents for a re-registration does not include preclinical and clinical parts, except PSUR (the chronological report on safety of use). Approbation of a quality monitoring is not required**. It means that in the course of a re-registration it is not required to import patterns of a medicine into Ukraine. Accordingly, there are no costs for laboratory fee.

*The given situation can be corrected, contact us for more information.

**The given feature is valid in case of absence of changes in a chemical part of the file.







2. The list and cost of company services Alenpharm

For a medical product re-registration the following list of services (in brief) will be rendered:

• accompaniment of dossier in the profile commissions, protection of interests of the Customer;
• renovation of the instruction, leaf-loose leaf, AND, packaging markings;
• translation of dossier (necessary parts), notarial translation of documents (Letter of attorney);
• request creation, PSUR preparation;
• drawing up files according to the legislation;
• submission of dossier in GFTS MOH of Ukraine;
• application submission in GFTS MOH of Ukraine;
• all other costs; cost of services covers all costs necessary for product registration, except the state payments.
• dossier copying in triplicate;
• sending of the documentation by means of express service (DHL);