Georgia

Population of Georgia is about 4 million people. The characteristics of pharmaceutical market are a low share of national manufacturers and a high dependency on imports. Local manufacturing covers about 15% of the need in medicines.

Georgia retains one of the leading positions in the DoingBusiness rating of the World Bank in creating favorable conditions for doing business and in the context of pharmaceutical market. Favorable and attractive conditions for importation and distribution of medicinal products are implemented by  alternative simplified recognition procedure  for marketing authorization of medicinal products approved in countries with high regulatory requirements, excluding of VAT, revoking of import licensing and allowance of parallel import.

Medicinal products can be registered either by recognition (simplified) procedure or by full dossier examination (full) procedure.

Registration of medical devices in Georgia is not required, but prior to importation and marketing it would be necessary to obtain a letter from the Ministry of Labor, Health and Social Affairs of Georgia related to product classification.

The situation is similar for food products and supplements and for cosmetic products: registration of these products is not required, however before importation we recommend to obtain a letter from the Ministry of Labor, Health and Social Affairs of Georgia regarding classification of the product and no need in its registration.

Medicinal products

The main legislative acts are the Law of Georgia “On Medicines and Pharmaceutical Activities”, Order of the Minister of Health, Labor and Social Affairs of Georgia No.337/N “Labeling requirements of pharmaceutical products admitted to the Georgian market under the national regime of state registration”.

According to the Law “On Medicines and Pharmaceutical Activities”, marketing of medicinal products in Georgia is allowed after the procedure of “marketing authorization of a pharmaceutical product”. Authorization includes passing examination and entering data about a medicinal product intoStateRegistry. Authorization procedure for medicinal products may be conducted in two ways:

• by recognition registration procedure;
• by national registration procedure.

Recognition registration procedure (simplified procedure) may be applied for medicinal products registered by competent authorities of the countries with high regulatory requirements according to the list established by the Government of Georgia. Such reference authorities include EMA (European Medicines Agency) as well as state regulatory authorities of EU Member States, USA, Australia and New Zealand, Canada, Japan, Korea, Switzerland and some other countries.

Registration is carried out on behalf of an  Applicant (Marketing Authorization Holder). Both resident and non-resident legal entity including the manufacturing site itself may apply as Applicant in the country. Applicant is responsible for quality, safety and efficacy of medicinal products. The company “Cratia” may represent interests of Applicants  based on power of attorney.

Registration of medicinal products is carried out by the Ministry of Labor, Health and Social Affairs of Georgia, and the competent authority that performs examination of registration materials is the State Regulation Agency for Medical Activities of Georgia (website: moh.gov.ge).

Registration of new product by recognition procedure:

For recognition procedure registration dossier should be submitted together with reference standards in quantity required for double laboratory analysis and registration samples in quantity of two packs or in quantity required for double analysis as well.

Package mock up submitted during recognition procedure should correspond to packaging approved and marketed in the referent country.

In case of submission of the dossier and package mock ups in English instruction for medical use should be translated into Georgian language only.

In case of providing registration documents in other language whole administrative part as well as package mock ups should be submitted into Georgian.

Technical part of the dossier can be provided in English language in electronic format.

Duration of registration be recognition procedure is 15 days.
Additionally replies to deficiencies should be provided in 15 days.

Registration certificate is issued for 5 years or it can be unlimited in case if unlimited marketing authorization is issued in the referent country.

Approved instruction for medical use as well as package mock ups are published on the web site of Ministry of Labor, Health and Social Affairs of Georgia.

Registration of new product by national procedure:

Documents for examination should be submitted to the Agency in national format along with samples of finished product and reference standards in quantity for two laboratory analysis. CTD format is not accepted.

During examination process the competent authority may provide queries and observations which should be replied by Applicant within 2-months period. If Applicant fails to reply to queries within set timelines, registration process for medicinal product may be withdrawn.

Inspection of manufacturing site is not foreseen in the legislation.

Approximate registration period is about 3 months, excluding clock stops for manufacturing site to  respond to observations.

Registration certificate (marketing authorization) is valid for 5 years. Medicinal products distribution in the territory of Georgia is permitted after expiration of registration period, until the products  expiry date.

Requirements to registration dossier by national procedure:

Registration documents are formed according to national  format and consist of two parts: administrative and scientific-technical. Administrative part should be presented in Georgian language, it should be submitted in paper form. Scientific-technical part may be provided in Georgian, Russian or English , and it may be submitted in paper form in three copies or in electronic form.

Instruction for medical use should be submitted in Georgian or together with its translation to Georgia.

Package labeling can be presented in Georgian and/or Russian and/or English. Multilingual packages are also accepted.

Variations and renewals:

During validity period of registration certificate, Applicant may initiate introduction of changes. For this purpose submission of Application form and corresponding package of documents would be needed. There are several types of variations(IA, IB, II) which also differentiate by time of their examination.

For renewal (repeated registration) application form and registration documents must be submitted no later than in 2 months before expiration of registration certificate otherwise it will be subjected for new registration. Renewal process is similar to new registration, but the list of documents required for renewal is shorter.

A certificate issued after renewal completion is valid for 5 years.

Pharmacovigilance

Currently Applicant has no obligation to establish and maintain a pharmacovigilance system in Georgia. Information on adverse reactions is submitted in paper form with seal and signature. Timelines for reporting of adverse reactions are following:

• unexpected serious adverse reactions: two days,

• other types: within a month.

Despite absence of a mandatory requirement to establish and maintain a pharmacovigilance system, “Cratia” offers a range of activities to manage safety of medicinal products in Georgia. We are ready to offer outsourcing of a local contact person, collection of data on adverse events, monitoring of literary sources and websites, periodic review and amendmentof instructions for medical use.

Medical devices and equipment

Registration of medical devices is not required in Georgia, however medical devices are certified for importation. Prior importation it is recommended to obtain a letter from the Ministry of Labor, Health and Social Affairs of Georgia confirming that the imported product ation is not a medicinal product and does not require registration.

Food products and supplements

Registration of food supplements, baby food, sport nutrition, medical nutrition in Georgia is not required. However it is recommended to obtain a letter from the Ministry of Labor, Health and Social Affairs of Georgia confirming unnecessity of the product registration.  The letter will help to avoid problems in the process of the product importation and marketing.

Cosmetic products

Registration of cosmetic products in Georgia is not required. However, it is recommended to receive a letter  from the Ministry of Labor, Health and Social Affairs of Georgia  confirming unnecessity of the product registration. regarding the absence of the need to register such a product. The letter answer will help to avoid problems in the process of the product importation and marketing distribution.

“Cratia” can provide services on state registration of medicinal products, establishment and maintenance of pharmacovigilance system, obtaining documents required for importation of medical devices, food products and supplements and cosmetic products in Georgia.