Medicinal Products Regulatory Support in Ukraine

Overview

The Ministry of Health (MoH) is the Ukrainian Health Authority and the central executive body of the healthcare system. The MoH - Ukraine accepts applications for the pharma product registration and issues orders related to approval or rejection of the products. The State Enterprise - State Expert Center (SEC) is the prominent drug Regulatory Authority under the Ministry of Health of Ukraine responsible for pharma product registration.

SEC carries out the preclinical study, clinical trials and state registration of drugs (including medical immunobiological drugs) within the limits set by the laws of Ukraine “On Medicinal Products” and “On Protection of the Population from Infectious Diseases”. It is also responsible for pharmacovigilance, standardization of medical care, development of relevant medical and technological documents, and draft regulations.

The State Service of Ukraine on Medicines and Drugs Control (SMDC) is the central executive authority formed to ensure implementation of the state policy in the sphere of quality control and safety of medicines, including medical immunobiological medicines, medical equipment and medical products.  It also governs the circulation of narcotic drugs, psychotropic substances and precursors, counteractions to their illicit trafficking, and carries out GMP inspections.

Medicinal product classification

Medicinal products are classified as:

  • Finished
  • Immunobiological
  • In-bulk
  • Active Pharmaceutical Ingredients (APIs)
  • Generic Medicines
  • Hybrid Medicines
  • Biosimilar

Medicinal product registration

If the manufacturer is from a foreign country, a local authorized agent should be appointed and the applications for pharma product registration should be submitted through the aforesaid agent. The authorized representative acts as a liaison between the manufacturer, the Ministry of Health (MOH), the State Enterprise "State Expert Centre of the Ministry of Health of Ukraine" (SEC) and any other private or government entity in Ukraine and carry out all the Pharmaceutical Regulatory requirements. The applicant should also appoint a contact person responsible for pharmacovigilance and product quality. To represent his interests, the applicant must issue a Power of Attorney (POA), which states the local representative's authority and submit it to the State Expert Center (SEC) and sign the agreement for expert evaluation. Laboratory control of the samples must be done in parallel to the application process.

The next step is completing the registration dossier. Then, applying for registration to MOH and submitting the Addendum to the Application to the SEC. After obtaining a positive response from the committees, the applicant should make payment for the government levy and expert evaluation. Once the confirmation of the payment is received, the applicant should send the confirmation to SEC. After that, the preliminary & expert evaluations are carried out on the dossier and a decision is delivered. Then the draft of the Registration Certificate, QCM, Instruction for medical use of the medicinal product, and the text of the packaging material and labeling is verified and transferred to the MOH. The MOH then signs the order on the registration of the medicinal product & issues the registration certificate. 

Product Maintenance & Compliance

Sl. No

Validity of Registration Certificate

Renewal

Post Approval Changes (Variations)

01

5 years.

The recommended deadline for submitting the Application is 12 months before the RC validity expiration.

Any changes regarding the quality, safety and efficacy of the medicinal product must be submitted by the Applicant according to the procedure for introduction changes.

Freyr Expertise

  • End-to-End Pharmaceutical Product Registration
  • Authorizes Local Agent Services
  • Pharma Regulatory Consulting and Pharma Market Entry
  • Regulatory Affairs & Regulatory Intelligence
  • Registration Pathways and License Management Services
  • Pharmaceutical Dossier Preparation, Review and Management
  • Regulatory Submissions and Approvals
  • Query Support Management till Approval
  • Product Information Leaflet (PIL)
  • Regulatory Labeling
  • GMP Recognition (certification) Support
  • Pharmaceutical Artwork Management
  • Ad-hoc Regulatory Affairs Consultation
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