Drug Registration and Market Access Legal Services
Pharmaceutical product registration is a fundamental legal step for any company wishing to sell medications on the Georgian market. Without registration, import, distribution, and sale of drugs are illegal and lead to severe sanctions. Georgia operates under two main registration regimes: Recognition (simplified) and National. Choosing the right regime, perfectly preparing the dossier, and fulfilling the obligations of the Marketing Authorization Holder (MAH) require specific legal knowledge. This process is not a one-time act; after registration, the company is obliged to continuously register variations and undergo a re-registration procedure every 5 years.
Legal.ge offers comprehensive legal services for drug registration. Our specialists act as your representatives at the Regulatory Agency, help manage bureaucratic processes, and ensure the legal and smooth entry of your products into the Georgian market.
What Does Drug Registration Service Cover?
Our service covers all stages of the registration cycle and includes:
- Strategy Planning: Preliminary product assessment to determine whether it qualifies for the "Recognition Regime" (faster and cheaper) or requires the "National Regime."
- Registration Dossier Preparation: Compiling administrative documentation, quality certificates (GMP), manufacturer data, and instructions in CTD (Common Technical Document) format.
- Agency Representation: Submitting the application, monitoring progress, and providing qualified answers to Agency experts' queries.
- Packaging and Labeling Adaptation: Legal review and adaptation of primary and secondary packaging designs and the Patient Information Leaflet (PIL) into Georgian.
- Variation Management: Registering post-authorization changes (Type I, Type II variations), such as packaging changes, shelf-life extension, or manufacturer changes.
- Trademark Protection: Checking intellectual property rights during the registration process to avoid infringing on others' patents or trademarks.
Common Situations and Scenarios
A typical scenario involves registering a medication manufactured in India or China. Since these countries are not on Georgia's list of recognized strict regulators, registration must proceed via the National Regime. This is a complex process requiring laboratory analysis of samples and submission of extensive clinical data. A lawyer helps the client prepare this complex dossier to avoid rejection.
Another scenario is missing the re-registration deadline. The registration certificate is valid for 5 years. If the company does not apply for renewal before expiration, the registration is cancelled, and the process must start from scratch. A lawyer monitors the client's portfolio and initiates re-registration in a timely manner.
Georgian Legislation and Legal Framework
Drug registration is regulated by the Law on Medicines and Pharmaceutical Activities and the Government Decree "On Rules for Registration of Pharmaceutical Products". Legislation strictly mandates compliance with GMP (Good Manufacturing Practice) standards. For the Recognition Regime, it is crucial that the drug is registered in the EU, USA, Japan, or other recognized countries.
Process of Receiving Services
The process begins with a product audit: does it have a GMP certificate and where is it registered? Then the lawyer prepares the registration application. In the case of the Recognition Regime, the process takes 7 working days; for the National Regime, 3 to 6 months. After registration is complete, a Registration Certificate is issued, confirming the product's legal status. Legal.ge specialists also assist with post-marketing obligations, such as pharmacovigilance.
With our help, you will avoid bureaucratic labyrinths and ensure the legal development of your pharmaceutical business.
Why Choose a Specialist on Legal.ge?
Drug registration is not just a formal procedure; it is a strategic step for market entry. An incorrectly prepared dossier can halt sales for months. Legal.ge experts have years of experience dealing with the Regulatory Agency and know all the "pitfalls" accompanying the registration process.
Updated: ...