Snapshot

The Recognition of the state registration pathway has been developed by the Agency for State Regulation of Medical Activities of Georgia of Georgia.

This pathway can be used where Medicinal products registered by competent authorities with high regulatory requirements..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Japan New Zealand South Korea Switzerland United Kingdom United States

According to the Law “On Medicinal Products and Pharmaceutical Activity”, circulation of the medicines on the Georgian market is permitted after the procedure of “admitting a pharmaceutical product to the market”. Admission includes assessment procedure and entry of the product into the state registry. There are two routes for registration: (i) fast-track, by recognizing the state registration of a pharmaceutical product, or (ii) through the national state assessment of a pharmaceutical product. Initial registration by recognition procedure: For the procedure, a package of documents is submitted along with reference standards in an amount sufficient for 2 tests, and samples of 2 packages of the finished product or also in an amount sufficient for 2 tests. For the recognition procedure, a packaging layout is submitted and approved; it must correspond to the packaging layout registered and authorized for sale on the pharmaceutical market of the reference country, the registration of which is recognized. When submitting documents and layout design in English, it is necessary to translate only instructions for human use into Georgian. When documents are submitted in another language, all administrative documents, including packaging design, are translated into Georgian, followed by notarization. The technical part is provided only in the electronic form in English. The registration procedure term is 15 calendar days. A period of up to 15 calendar days is provided to correct comments to the dossier. Based on the results of the expert evaluation of registration documents, a Marketing Authorization is issued for a period of 5 years. Approved packaging and instructions for human use are posted on the website of the Ministry of Labor, Health and Social Affairs of Georgia. Initial registration by the national procedure: Documents for expert evaluation are submitted to the Agency in a local format along with samples of the finished medicinal product and reference standards necessary for conducting a double test. The dossier is submitted in the national format, the CTD format is not accepted. Registration documents are submitted in a local format and consist of two parts: administrative and scientific and technical. The administrative part must be provided in Georgian and submitted in paper form, and the scientific and technical part must be provided in Georgian, Russian or English in triplicate, and may be submitted in paper or electronic form. Instructions for use are submitted in Georgian or with translation into Georgian. Labeling of the packaging may be in Georgian and/or Latin and/or Slavic-Cyrillic alphabet. Registration of multilingual packaging is allowed. During the expert evaluation, the competent authority may have comments, for the elimination of which the Applicant is given a period of up to 2 months. A medicinal product may be withdrawn from the registration procedure if it is not possible to eliminate the comments within the indicated period. The approximate registration period is about 3 months, excluding the time required to the manufacturer in providing responses to comments. The Мarketing Аuthorization is valid for 5 years. The circulation of a pharmaceutical product in Georgia is permitted after the expiration of the registration until the shelf life expiration.