Registration of medicines

The main document that regulates the circulation of medicines in Ukraine is the Law "On Medicines" dated April 4, 1996. All rights and obligations in this area are civil, enterprises, government agencies.

According to the Law, a drug is a substance / combination of substances used for the treatment and prevention of diseases, which can also be prescribed to prevent pregnancy, restore, correct, change physiological functions or to establish a medical diagnosis.

Registration of medicinal products in Ukraine is mandatory for all products that are subject to sale in the country - domestically produced and imported. Medicines made according to standard formulas ordered by medical institutions from officially approved substances, as well as produced according to mainstream formulas and dispensed by prescription do not require registration of drugs in Ukraine.

Basic rules for registration of medicines in Ukraine

Registration is carried out on the basis of an expert examination of drugs, the duration of its validity is established by law. 

Changes to the registration documents during the validity of the registration certificate of the medication are regulated by the norms established in the EU.

The amount that is paid for registration includes the payment for the examination and the state fee.

The procedure for re-registration of a medicinal product begins no later than 90 days before the expiration date of the current registration certificate.

The procedure for registration of medicines

1. An application with a package of necessary documents is submitted to the State Pharmacological Center under the Ministry of Health, an agreement is concluded for an examination;
2. The Pharmacological Center conducts an examination of the quality and effectiveness of the drug;
3. A special commission of the Ministry of Health checks the results of the examination;
4. A certificate is issued for a medicinal product.

Registration of medicines in Ukraine requires a deep knowledge of the legal framework, as well as the specifics of this issue. In order to avoid any problems in the process of paperwork, we recommend that you entrust the support of the procedure to the lawyers of "RegService".

The range of services for the registration of medicines of our company includes:

1. collection and execution of a package of documents;
2. submitting them to the MHU;
3. support of the registration procedure;
4. obtaining a certificate and transferring it to the client.

If you still have questions about collecting a package of documents or other nuances of registration, ask our specialists. You can order a preliminary consultation by calling the phone number indicated on the website, writing to an email address or filling out the feedback form.

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