The main legislative acts are the Law of Georgia “On Medicinal Products and Pharmaceutical Activities”, Order of the Minister of Labor, Health and Social Affairs of Georgia No. 337/N “Requirements for Labeling of Pharmaceutical Products Admitted to the Georgian Market under the National State Registration Regime”.
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:
- fast-track, by recognizing the state registration of a pharmaceutical product, or
- through the national state assessment of a pharmaceutical product.
Recognition of the state registration (simplified or fast-track procedure) is applied to medicinal products registered by competent authorities with high regulatory requirements, according to the list established by the Government of Georgia. Such reference bodies include the EMA (European Medicines Agency), as well as the state regulatory authorities of the member states of the EU, USA, Australia and New Zealand, Canada, Japan, Korea, Switzerland and some other countries.
The national registration procedure is performed for all other medicinal products. As a result of each registration procedure, a Marketing Authorization is issued for a period of 5 years.
The inspection of production during the registration process is not provided for by law.
Registration is conducted in the name of the Applicant (Marketing Authorization Holder), which may be a non-resident legal entity, including the manufacturer itself. The Applicant is responsible for the quality, safety and efficacy of the medicinal products. Cratia may represent the interests of the Applicant by proxy.
The registration of medicinal products is carried out by the Ministry of Labor, Health and Social Affairs of Georgia, and the Agency for State Regulation of Medical Activities of Georgia is the competent authority for the expert evaluation of registration materials (website: moh.gov.ge).
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.
Changes (variaitons) and renewal procedure
During the validity of the Мarketing Аuthorization, the Applicant may initiate amendment, for which it is necessary to submit an Application and the corresponding package of documents. There are several types of changes (IA, IB, II), which affects the duration of their expert evaluation.
For the Marketing Authorization renewal of a pharmaceutical product, the Application and registration documents must be submitted no later than 2 months before the expiration of the registration period, otherwise the registration of the medicinal product is carried out in the initial model of the primary registration. The renewal procedure is similar to the initial registration, but the list of documents is shortened.
As a result of the renewal procedure, a Marketing Authorization is issued for the next 5 years.
Cratia provides professional services of state registration of medicines in Georgia. We have an excellent knowledge of national legislation, necessary experience and resources. We have an excellent knowledge of national legislation, necessary experience and resources.