Ministry of Health of the Republic of Azerbaijan
Azerbaijan Energy Regulatory Agency
5 Years
2 months before the expiration of the registration period.
126 US$11 (New chemical entity and generic)
The dossier should be submitted in eCTD (Common Technical Document) format.
For the procedure, a package of documents is submitted 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.
In the recognition process, a packaging design is submitted and approved. It should match the registered and authorized packaging layout of the reference country’s pharmaceutical market, whose registration is acknowledged. If documents and design are in English, only the instructions for human use need to be translated into Georgian when submitting them.
If the documents are in a different language, all administrative papers, including packaging design, are translated into Georgian and then notarized. The technical portion is given only in electronic form in English.
15 Calendar days.
Based on the results of the expert evaluation of registration documents, a Marketing Authorization is issued.
The Ministry of Labor, Health, and Social Affairs of Georgia uploads the authorized packaging and user instructions on its website.
Documents for expert assessment are presented to the Agency in a local format, including samples of the final medicine and reference standards required for a double test. The dossier should be in the national format, and the CTD format is not acceptable.
Registration documents are presented in a local style and consist of two parts: administrative and scientific-technical. The administrative portion should be in Georgian and submitted in hard copy, while the scientific-technical part should be in Georgian, Russian, or English, provided in triplicate, and can be submitted in either hard copy or electronic form.
Instructions for use should be in Georgian or with a translation into Georgian.
Packaging labels may be in Georgian, and/or Latin, and/or Slavic-Cyrillic alphabets. Multilingual packaging registration is permitted. During the expert assessment phase, the relevant authority may provide feedback, and the Applicant is granted a period of up to 2 months to address and resolve these comments. If the comments cannot be addressed within the specified timeframe, the medicinal product may be removed from the registration process.
3 months (excluding the time required to the manufacturer in providing responses to comments.)
In Georgia, a pharmaceutical product may be circulated up until the shelf life expires after the registration expires.
4.1 Document confirming the registration of the medicinal product in the manufacturing country (original or notarized copy) – Certificate of Pharmaceutical Product, Free Sale Certificate, or Registration Certificate.
4.2 Document confirming the registration of the medicinal product in other countries, as approved by the manufacturer (if required, provide a notarially certified copy of registration certificates).
4.3 For medical products manufactured under license, provide a notarially certified copy of the license holder’s permission.
4.4 Document confirming the manufacturing of the medicinal product and evidence of manufacturing under conditions consistent with reliable manufacturing practices (original or notarially certified copy) – Manufacturing license and GMP certificate.
4.5. Certificate of Analysis of the finished drug product, active ingredients, and excipients (COA) – provide a copy certified by the manufacturer.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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