The Georgian pharmaceutical market presents a significant opportunity for international companies looking to expand their presence in the Caucasus region. With a population of over 3.7 million and a growing healthcare sector, Georgia offers a promising environment for the registration and sale of pharmaceutical products.
In 2020, the Georgian pharmaceutical market was valued at approximately USD 400 million, with a projected annual growth rate of 5-7% over the next five years.
However, the regulatory landscape in Georgia can be complex for international regulatory managers unfamiliar with the country’s specific requirements. Here we provide a detailed overview of the pharmaceutical registration process in Georgia, enabling regulatory professionals to make informed decisions and streamline their market entry strategies.
Regulatory authorities and laws
The main regulatory body overseeing pharmaceutical products in Georgia is the State Regulation Agency of Medical Activities (RAMA), which operates under the Ministry of Internally Displaced Persons from Occupied Territories, Labour, Health and Social Affairs (Ministry of Health). The RAMA is responsible for enforcing the rules established by the Ministry of Health through:
- Granting marketing authorizations
- Managing the registry of pharmaceutical products
- Ensuring the removal of non-compliant products from the market
- Conducting inspections of pharmaceutical manufacturing facilities and distribution channels
- Monitoring the quality and safety of marketed products through pharmacovigilance activities
Key legislation governing pharmaceutical registration in Georgia includes:
- The Law of Georgia on Drugs and Pharmaceutical Activity (1996)
- Establishes the legal framework for the regulation of pharmaceutical products and activities
- Defines the roles and responsibilities of the Ministry of Health and RAMA
- Sets out the requirements for the registration, manufacture, import, and distribution of pharmaceuticals
- Decree No. 176 on the Registration of Pharmaceutical Products (2009)
- Outlines the specific requirements and procedures for the registration of pharmaceutical products
- Defines the documentation and data required for registration applications
- Specifies the timelines and fees associated with the registration process
It is crucial for international regulatory managers to familiarize themselves with these legal frameworks to ensure compliance and successful registration of their products.
Engaging local regulatory experts, such as Delta Medical, can help manage the complexities of Georgian pharmaceutical legislation and streamline the registration process.
Types of Pharmaceutical Registration Procedures in Georgia
Georgia offers two main registration pathways for pharmaceutical products:
- Recognition of state registration (simplified procedure)
- Applicable for products already registered in specific countries, such as the EU, USA, Canada, Japan, and others, as determined by the Government of Georgia
- Requires submission of administrative documents, including:
- Patient information leaflet in original and Georgian languages
- Product information (form, dosage, labeling sample, reference standard)
- Certificate of Pharmaceutical Product (CPP) or equivalent document
- Examination and registration can be completed within 7 working days
- Registration is valid for 5 years or unlimited if the marketing authorization in the reference country is unlimited
- National state registration procedure (standard)
- Applicable for products that do not qualify for the simplified recognition procedure
- Requires submission of a more extensive set of documents, including:
- Administrative documents (application, power of attorney, CPP, GMP certificates, proposed mockups)
- Scientific and technical documentation (chemical, pharmaceutical, biological, pharmacological, toxicological, and clinical data)
- Samples of the medicinal product and reference standards
- Examination and registration process can take up to 3 months, excluding time for the applicant to address queries
- Registration certificate is valid for 5 years
The simplified recognition procedure can significantly reduce the time and resources required for registration, making it an attractive option for products already approved in major markets.
Required documentation and submission process
To successfully register a pharmaceutical product in Georgia, regulatory managers must prepare a comprehensive dossier containing both administrative and scientific-technical documentation.
The specific requirements may vary depending on the chosen registration pathway (simplified recognition or national procedure), but the following key documents are generally required:
Administrative documents
- Application form and fees
- Completed application form in Georgian or English
- Payment of the applicable registration fees (e.g., 500 GEL for the simplified procedure, 2000 GEL for the national procedure)
- Instruction leaflet, product information, and labeling sample
- Patient information leaflet (PIL) in the original language and Georgian translation
- Summary of Product Characteristics (SmPC) or equivalent document
- Proposed labeling and packaging materials, including mock-ups
- Certificate of Pharmaceutical Product (CPP) or Free Sale Certificate
- Issued by the competent authority in the country of origin or reference country
- Must be legalized or apostilled, and translated into Georgian if necessary
- Power of Attorney and GMP certificate
- Notarized Power of Attorney authorizing a local representative to handle the registration process
- Valid GMP certificate for the manufacturing site(s), issued by a recognized regulatory authority
Scientific-technical documentation
- Chemical, pharmaceutical, and biological documentation
- Drug substance and drug product quality data (e.g., composition, manufacturing process, specifications, stability data)
- Analytical methods and validation reports
- Certificate of Analysis (CoA) for the drug substance and finished product
- Pharmacological and toxicological documentation
- Non-clinical pharmacology and pharmacokinetics data
- Toxicology studies (single-dose, repeat-dose, genotoxicity, reproductive toxicity, carcinogenicity)
- Environmental risk assessment, if applicable
- Clinical documentation and expert reports
- Clinical pharmacology data (pharmacokinetics, pharmacodynamics, drug interactions)
- Clinical efficacy and safety data from pivotal trials
- Clinical study reports and summaries
- Expert reports on the quality, non-clinical, and clinical aspects of the product
Submission format and language requirements in Georgia
- The administrative part of the dossier must be submitted in Georgian or English
- The scientific-technical documentation can be submitted in Georgian, English, or Russian
- Electronic submission of the dossier (e.g., via CD-ROM or email) is generally accepted, but hard copies may be required upon request
Samples and reference standards
- Sufficient samples of the finished product and reference standards must be provided for quality control testing
- The quantity and specifications of the samples will be determined by the RAMA on a case-by-case basis
Regulatory managers should work closely with their local partners and experts to ensure that all required documents are obtained, translated, and submitted in accordance with Georgian requirements.
Key Factors for International Pharmaceutical Companies Entering the Georgian Market
When planning to enter the Georgian pharmaceutical market, international companies should keep the following key considerations in mind:
- Appointing a local representative or partner
- It is highly recommended to appoint a local representative or partner with expertise in Georgian pharmaceutical regulations and market dynamics
- Local partners can help manage the registration process, liaise with authorities, and provide valuable insights into the competitive landscape
- Translation and localization of product information
- All product information, including labeling and package inserts, must be translated into Georgian
- Translations should be performed by certified translation services and reviewed for accuracy and compliance with local requirements
- Pricing and reimbursement strategies
- Georgia has a mixed public-private healthcare system, with a state-funded universal healthcare program and private insurance schemes
- Pharmaceutical companies should develop pricing and reimbursement strategies that take into account the local market conditions, competition, and patient affordability
- Intellectual property protection
- While Georgia has a legal framework for intellectual property protection, enforcement can be challenging in practice
- Companies should work with local legal experts to develop strategies for protecting their patents, trademarks, and other intellectual property rights
- Pharmacovigilance and adverse event reporting
- Marketing authorization holders are required to establish a pharmacovigilance system and report adverse events to the RAMA
- Companies should ensure that they have robust pharmacovigilance processes in place and train local staff on adverse event reporting requirements
To successfully navigate these challenges and optimize their market entry strategies, international pharmaceutical companies can benefit from partnering with experienced local service providers. For example, Delta Medical, a leading provider of regulatory affairs services in Georgia, offers a range of solutions to support international companies, including:
- Registration strategy development and dossier preparation
- Liaison with regulatory authorities and local stakeholders
- Translation and localization of product information
- Pharmacovigilance and safety reporting services
- Market access and commercialization support
By leveraging the expertise of local partners like Delta Medical, international pharmaceutical companies can streamline their entry into the Georgian market, ensure compliance with local regulations, and maximize their chances of success.
Post-registration obligations and renewals
Once a pharmaceutical product has been successfully registered in Georgia, marketing authorization holders (MAHs) must comply with various post-registration obligations to maintain their license and ensure the continued quality, safety, and efficacy of their products.
Labeling requirements at the point of sale in Georgia
- All pharmaceutical products must be labeled in Georgian at the point of sale
- Labels must include essential information such as the product name, active ingredients, dosage form, strength, batch number, expiry date, storage conditions, and name and address of the MAH
- Any changes to the approved labeling must be submitted to the RAMA for approval prior to implementation
Reporting changes and variations to registered products
- MAHs are required to notify the RAMA of any changes or variations to the registered product, such as changes in composition, manufacturing process, or product information
- Variations are classified into minor (Type IA and IB) and major (Type II) categories, each with specific submission requirements and timelines
- MAHs must assess the impact of the proposed changes on the quality, safety, and efficacy of the product and provide supporting documentation as necessary
Renewal process and timeline in Georgia
- Marketing authorizations granted through the simplified recognition procedure are valid for 5 years or unlimited if the reference country’s authorization is unlimited
- Marketing authorizations granted through the national procedure are valid for 5 years
- MAHs must submit a renewal application to the RAMA at least 2 months before the expiration of the current authorization
- The renewal application should include updated quality, safety, and efficacy data, as well as information on any changes or variations implemented since the initial registration
- The RAMA will review the renewal application and make a decision within 2 months, provided that the application is complete and no further information is required
Pharmacovigilance requirements in Georgia
- MAHs are responsible for continuously monitoring the safety of their products and reporting any adverse events or safety concerns to the RAMA
- MAHs must appoint a qualified person responsible for pharmacovigilance (QPPV) who will oversee the company’s pharmacovigilance activities in Georgia
- Adverse events must be reported to the RAMA within 15 calendar days for serious cases and 90 calendar days for non-serious cases
- MAHs should maintain a pharmacovigilance system master file (PSMF) that describes their global pharmacovigilance system and its application in Georgia
Consequences of non-compliance
- Failure to comply with post-registration obligations can result in various penalties, including fines, suspension or revocation of the marketing authorization, and criminal liability in severe cases
- The RAMA conducts regular inspections of MAHs to ensure compliance with good pharmacovigilance practices (GVP) and other regulatory requirements
- MAHs should establish robust quality management systems and standard operating procedures (SOPs) to ensure ongoing compliance and promptly address any identified deficiencies
Key Takeaways and Helpful Resources
Registering a pharmaceutical product in Georgia requires a thorough understanding of the country’s regulatory framework, submission requirements, and post-registration obligations.
Key takeaways for successful pharmaceutical registration in Georgia include:
- Choosing the appropriate registration pathway based on the product’s existing approvals and target market
- Preparing a complete and well-organized registration dossier that meets Georgian requirements
- Engaging local partners and experts to support the registration process and ensure compliance
- Establishing robust pharmacovigilance and quality management systems to maintain the marketing authorization and ensure patient safety
To stay updated on the latest regulatory developments and industry trends in Georgia, regulatory managers can consult the following resources:
- State Regulation Agency of Medical Activities
- Ministry of Internally Displaced Persons from Occupied Territories, Labour, Health and Social Affairs (Ministry of Health)
- Georgian Law on Drugs and Pharmaceutical Activity
- Decree No. 176 on the Registration of Pharmaceutical Products
- Delta Medical – Regulatory Affairs Services in Georgia
By leveraging these resources and partnering with experienced local service providers like Delta Medical, international pharmaceutical companies can confidently enter the Georgian market and contribute to the country’s growing healthcare sector.
