Pharmaceutical Labeling and Packaging Compliance in Georgia
Pharmaceutical product labeling and marking is not just a design issue; it is a fundamental component of patient safety and a strict prerequisite for market access. Georgian legislation details exactly what information must be displayed on primary (e.g., blister, ampoule) and secondary (box) packaging, as well as the content of the patient information leaflet (PIL). Any non-compliance—whether a language barrier, incomplete warning, or technical error—leads to import suspension, product confiscation, or substantial fines. Moreover, incorrect labeling can result in patient health injury and manufacturer liability.
Legal.ge offers expert legal services regarding pharmaceutical labeling compliance. Our specialists ensure that your product's packaging and instructions fully meet Georgian legislation, including the requirements of the "Law on Medicines and Pharmaceutical Activities." We help both local manufacturers and importers avoid regulatory barriers and ensure the uninterrupted circulation of products.
What Does Pharmaceutical Labeling Service Cover?
Our service covers all aspects of labeling, from text drafting to submission to the regulatory body:
- Label and Packaging Audit: Reviewing primary and secondary packaging designs for compliance with Georgian law (font size, mandatory symbols, storage conditions).
- Patient Information Leaflet (PIL) Adaptation: Translating and adapting the instruction for use into Georgian, adhering to medical terminology and the legally required structure.
- Language Compliance: Ensuring all mandatory information is presented in the Georgian language, considering the requirements of the "Law on Consumer Rights Protection."
- Regulatory Approval: Submitting and agreeing on label and packaging mock-ups with the Regulation Agency for Medical and Pharmaceutical Activities during the registration process.
- Variation Management: Legally processing and notifying changes to existing labels (e.g., adding a new side effect).
- Parallel Import Labeling: Specific consultation on mandatory repackaging/labeling rules during parallel import operations.
Common Situations and Risks
A typical problem is the direct import of foreign packaging. Often, an importer brings in a drug where the box text is only in a foreign language. Under Georgian law, if the product does not undergo repackaging or stickering in Georgian, its sale is prohibited. A lawyer helps the company develop a stickering plan that satisfies the regulator.
Another scenario is an error in the instruction. For example, if the Georgian translation incorrectly states dosage or omits a significant contraindication, this creates a life-threatening risk for the patient. In such cases, the company faces not only product recall but also potential criminal liability. Verification of documentation by a lawyer beforehand minimizes these risks.
Georgian Legislation and Legal Framework
Labeling rules are regulated by the Law on Medicines and Pharmaceutical Activities and Government technical regulations on pharmaceutical product registration rules. Crucially, the Law on Consumer Rights Protection obliges businesses to provide information to consumers in the state language, clearly and understandably. The Code on Product Safety and Free Movement also applies, setting general requirements.
Process of Receiving Services
The process begins with an analysis of the product's original packaging and instruction (SmPC/PIL). The lawyer compares it with Georgian legislative requirements. If necessary, text correction or translation is performed. Then, prepared mock-ups are sent to the Regulatory Agency for approval. In the case of parallel import, the lawyer ensures obtaining a repackaging permit. A Legal.ge specialist stands by you until final approval is received.
Correct labeling is a guarantee of your business reputation and patient trust. Trust professionals to avoid expensive mistakes.
Why Choose a Specialist on Legal.ge?
Pharmaceutical labeling requires a synthesis of legal, medical, and linguistic knowledge. Legal.ge gives you access to specialists experienced in working with the Regulatory Agency who know all the technical nuances (from font size to pictograms) necessary for problem-free registration.
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