Issue 2, 2010, April-May, Magazine Investor.ge
Natalia Babakishvili and Anna Tabidze, Lawyers MKD,analyzes the new legislation and regulation of imports of pharmaceutical products.
Over the past several months, the Georgian government has amended the country’s laws regulating pharmaceutical products and sales. There are many reasons for the changes, including the government’s stated policy to insure an open market for competition, simplifying imports of high quality products and reducing market prices.
Simplified Admission to the Georgian Market
According to Georgian legislation, pharmaceutical products must be registered with the Departmental Registry at the Agency of State Regulation of Medical Activities at the Ministry of Labor, Health and Social Protection of Georgia (the Agency) before they can be sold in the country.
The new laws regulating pharmaceutical products imported and sold in Georgia attempt to simplify the registration process for new kinds of medicine entering the market. The new legislation allows for importers or pharmaceutical manufacturers to register their products based on two types of “recognition”: prior recognition by an accepted international partner or national recognition.
State Registration Based on Prior Approval
Brand name or generic pharmaceutical products can be registered in Georgia based on their acceptance by a pre-approved intergovernmental pharmaceutical regulatory body or the regulatory body of foreign country.
The list of the accepted regulatory bodies includes the European Medicines Agency (EMEA) and the regulatory bodies of various European countries, as well as that of the United States of America, Japan, Australia and New Zealand.
According to the government, utilizing the experience of approved, foreign regulation bodies will simplify the registration process and facilitate the entry of pharmaceuticals that are recognized by various developed states.
Another important aspect of the new legislation is that it does not limit either the type of importing party or the purpose of the import. For the sake of the recognition procedure, the interested party may be any natural or legal person wishing to register/admit certain pharmaceutical products into the market, notwithstanding the aim of the import.
The list of documents to be submitted for a first time import is the application, documented evidence of payment of the registration fee (500 lari), and a number of documents including:
- the original instructions and an authorized Georgian translation thereof;
- form, dosing and original/electronic label sample of the pharmaceutical product as well as reference standard for two tests or active substance of the respective pharmaceutical product;
- the period of admission of the pharmaceutical product into the respective market by an intergovernmental regulatory body for pharmaceutical products or a regulatory body of foreign countries;
- the unique (authorization) number of admission of the pharmaceutical product into the respective market;
- a certificate of the pharmaceutical product issued by an intergovernmental regulatory body for pharmaceutical products or a regulatory body of foreign countries or other equivalent document;
- any test methods which may be printed out from a public source (pharmacopoeia) along with the reference to such source;
- a sample of the pharmaceutical product – two standard packages or the quantity required for two tests.
To further simplify the procedure, the legislation of Georgia allows for homology identification documents in several languages: Georgian, English or Russian.
Once the documents have been submitted, the Agency reviews them and registers the information concerning the pharmaceutical product with the Departmental Registry within seven business days.
State Registration through National Regime
The second type of registration is known as national recognition.
This procedure was created for pharmaceutical manufacturers or trade license holders. To register, the party concerned must submit an application, proof of payment of the registration fee - 2,500 lari for a brand name pharmaceutical product and 500 lari for generic pharmaceutical product - and registration documents consisting of administrative and scientific and technical information to the Agency.
The administrative documents should be filed in Georgian whereas the scientific and technical documents may be submitted in Georgian, English or Russian. They may be filed electronically, as well.
Once the documents are submitted, the Agency must review them within 14 days.
If the documents are in order, the Agency will conduct a scientific and technical examination of the product to establish its standardization, quality, safety as well and therapeutic worth.
The Agency has two months to deliberate the product’s registration. Once approved, the Agency must issue a document allowing the admission of the pharmaceutical product into the Georgian market within ten days.