2. Nearly 70 licences have been issued to pharmaceutical enterprises in Georgia up to date. However, only about ten of them have real manufacturing facilities. The others are either small producers or manufacturers of so called “Traditional medicines” (e.g., the Turmanidzes and their famous ointment), which had to to apply for the licence to avoid illegality.

3. Major pharmaceutical manufacturers: 1.GM Pharmaceuticals 2.Aversi-Rational 3.Biopolus (former Batpharma) 4.Biopharm 5.AbiPharm 6.Neopharm 7.Gama 8.Pharmimpex 9.NaturoPharm 10.Phytopharm 11. Iveriapharm

4. Most of the companies perform the whole production cycle from API to finished dosage forms. Some of them (e.g., Aversi-Rational) performs only packaging of the imported finished products (tablets, capsules) Chemical APIs are not produced in Georgia. It is not categorized as pharmaceutical industry. It is included in chemical industry and is related to the environmental protection problems, because of which 82% of world APIs are produced in third countries (China, India). Georgia is rich in medicinal herbs and traditional herbal products (extracts) are produced there. One should emphasize on Platiphillin extract as this plant containing high q-ty of alcaloid platifillin is grown in Georgia only. Unfortunately, share of export of herbal extracts is decreasing because of loss of traditional markets (CIS) and lack of standards acceptable for European market.

5. Local pharmaceutical products account for 8- 9% of total pharmaceutical market of Georgia

6. GENERICS vs ORIGINALS New Product GenericOriginator

7. Advantages Replacement of import Generics equivalent to Original products Products, which are cheaper than original products Permanent stock of essential pharmaceutical products and ability of production in case of emergency in the country Employment of local personnel and upgrading the skills to international standards Production under license of western brands in Georgia Export

8. Statistics of pharmaceutical markets in Eastern European countries CROATIA SLOVENIA

9. LATVIA Statistics of pharmaceutical markets in Eastern European countries Lithuania

10. Export ( X 1000 $)

11. CountryRegisteredPending for registration Ukraine 512 Belorussia 510 Russia 1 Moldova 2511 Armenia 2511 Azerbaijan 110 Uzbekistan 5123 Tajikistan 483 Kyrgyzstan 407 Kazakhstan 109 Turkmenistan 181 Vietnam 6 Lybia 454 France 1 ECOWAS ( 15 Economic Community of West African States ) 72 GM Pharmaceuticaals Ltd. Export Countries

13. Good Manufacturing Practice (GMP) In developed countries pharmaceutical industry is based on principles of Good Manufacturing Practice (GMP). Pharmaceutical products will never be accepted at market of developed countries without maintaining this standard. Procedure of granting the GMP certificate to pharmaceutical enterprises is effective within EU. Actually, it is a key to European market. Georgian pharmaceutical products can be approved for foreign market only if pharmaceutical enterprise is certified against GMP Certification is the function of the National Regulatory Agencies!

14. Definition of GMP GMP is that part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization or product specification EU guidelines, Chapter 1

18. Pharmaceutical Inspection Convention (PIC) and Pharmaceutical Inspection Cooperation Scheme ( PIC Scheme ) Pharmaceutical inspection convention – PICs has been operating since 1970. It has the following goals: Mutual recognition between the pharmaceutical inspections of member states Harmonization of standards Harmonization of inspection methods Elaboration of methods for training the inspectors Exchange of information among the inspectors of member states and assuring the confidentiality of information Joining to PICs will enable Georgian pharmaceutical companies to have the results of national inspections and GMP certificate issued in Georgia recognized by the member states

19. CountryAccession to PICAccession to PIC Scheme AustriaMay 1971November 1999 DenmarkMay 1971November 1995 FinlandMay 1971January 1996 IcelandMay 1971November 1995 LiechtensteinMay 1971November 1995 NorwayMay 1971November 1995 PortugalMay 1971January 1999 SwedenMay 1971February 1996 SwitzerlandMay 1971February 1996 United KingdomMay 1971June 1999 HungaryAugust 1976December 1995 IrelandDecember 1977February 1996 RomaniaMay 1982November 1995 GermanySeptember 1983December 2000 ItalyAugust 1990February 2000 BelgiumSeptember 1991February 1997 FranceDecember 1992February 1997 AustraliaJanuary 1993November 1995 Netherlands-November 1995 Czech Republic-January 1997 Slovak Republic-January 1997 Spain-January 1998 Canada-January 1999 Singapore-January 2000 Greece-January 2002 Malaysia-January 2002 Ukraine - January 2012 USA-January 2012 PIC member states

20. World Health Organization Certification Scheme ”Certification scheme on the quality of pharmaceutical products moving in international commerce” enables the member states to use the scheme while importing and exporting the drugs after appropriate registration. The scheme regulates issuing of CPP – Certificate of Pharmaceutical Products by the national body. Submission of CPP is an essential requirement for registration of drugs in WHO member states. CPP must be issued by the National Regulatory Agency!

22. Arrangements contributing to local pharmaceutical industry: 1.Local market : Equating of local and imported medicines at state tenders State support in popularization of Georgian pharmaceutical products; overcoming the traditional distrust from doctors and patients Encouraging the generic prescriptions

23. 2. Arrangements contributing to export: -Recognition of international standards (GMP, GCP, GLP, GDP, GPP, US Pharmacopoeia, European Pharmacopoeia, British Pharmacopeia) and assigning a legal status to them -Certification of facilities against the GMP standard by the relevant authority of Georgia -Developing the method for granting the CPP (Certificate of Pharmaceutical Product) -Georgia’s joining to international organizations and international schemes: PIC, WHO scheme, MRA, Ph.EU -Harmonization of Georgian legislation to EU regulations

24. Future prospects of Georgian pharmaceutical industry for the nearest 10 years: 1.Share at local market - 40-45 % 2.Volume of exports > 500 000 000 $