New registration PM

new-regState registration of medicinal products (state marketing authorization) – procedure that is performed according to requirements of current legislation and Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) (order of MOH of Ukraine №426 from 26.08.2005) in order to approve medical use of a medicinal product.

 According to the Procedure all medicinal products submitted for state registration can be divided on two big groups:

Original drug

1. Original (innovator) medicinal product is a medicinal product which was first registered on the basis of full documentation related to its quality, safety and efficacy (full registration dossier) and with which the generic medicinal product shall be compared.

It is possible to attribute to this group also fixed combination – new medicinal product containing known active substances not used previously in this combination, as well as not used in medical practice in this combination as independent preparations in the same pharmaceutical form, strength and at the appropriate ratio.

Genetic drug

2. Generic medicinal product (interchangeable, multisource, essentially similar medicinal product) is a medicinal product which has the same quantitative and qualitative composition of active substances and the same pharmaceutical form as the reference medicinal product, and is interchangeable with the reference medicinal product. The different salts, esthers and esters, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and efficacy. In such cases, additional information providing proof of the safety and efficacy of the different salts, esters or derivatives of a registered active substance must be submitted by the Applicant. Various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Data about bio-availability studies need not be provided by the Applicant if he can demonstrate the generic medicinal product to meet relevant criteria as defined by MoH.

From the point of view of origin medicinal products are classified as:

  • Medical immunobiological products (hereinafter – MIP) are vaccines, toxins, immunoglobulins, sera, bacteriophages, interferons, bacterial preparations and other medicinal products, used in medical practice for specific prevention of infectious diseases; they are obtained through cultivation of microorganisms and eukaryote cells, extraction of substances from biological tissues and blood, including tissues and blood of human beings, animals and plants (allergens), use of recombinant DNA technology, hybrid technologies, alive agent reproduction in embryos or animals.
  • Homeopathic medicinal product – any medicinal product made of products, substances or compositions specified as homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the State Pharmacopoeia of Ukraine (SPh Ukraine) or the European Pharmacopoeia, or in the absence of such description – in the German Homeopathic (GHP), United States Pharmacopeia (HPUS), British Homeopathic Pharmacopoeia (BHP), Schwabe’s Homeopathic Pharmacopoeia. Homeopathic medicinal product may also contain a number of active substances (principles).
  • Radiopharmaceutical medicinal product – any medicinal product, when ready for use, contains one or more radionuclides (radioactive isotopes) included for medical purpose.
  • Biotechnological product – medicinal product manufactured using genetic engineering and post-fusional technology.
  • Herbal medicinal product – any medicinal product exclusively containing as active substances one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.

 The registration procedure and dossier structure for every type of medicinal preparations may have essential distinctions. Our specialists will help you to pass through all steps of registration procedure to receive registration certificate in shortest terms.