The pharmaceutical industry in Serbia contributes 0.7% to GDP and employs around 7,000 people. In 2011, the industry's gross production was over 450 million Euros. Domestic producers supply around 75% of medicines in Serbia by number of boxes sold, accounting for 45% of cash flow. While imports of medicines have been growing, exports have also increased, reaching 208.3 million dollars in 2011. The industry presents opportunities for growth through further privatization of domestic companies and EU integration.
This document provides safety information for a mixture called CIPC 300 g/L HN. It contains the following key details:
- The product is a mixture used as a plant growth regulator in agriculture.
- Prolonged or repeated exposure may cause damage to organs and is suspected of causing cancer. It can cause eye, skin and respiratory irritation and an allergic skin reaction.
- Precautions include obtaining special instructions before use, wearing protective equipment, and seeking medical advice if exposed, feeling unwell or experiencing skin or eye irritation. The product is toxic to aquatic life with long lasting effects.
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
This document summarizes changes in the global pharmaceutical market, including upcoming drug patent expirations and new drug launches. It finds that blockbuster drug sales make up a large portion of major pharmaceutical company revenues. It predicts that Roche will benefit the most from upcoming drug patent expirations at other companies. The largest growth areas for new drug development are seen as cancer, diabetes, hepatitis C, HIV, and multiple sclerosis. Companies with promising drug pipelines include Roche, GlaxoSmithKline, Biogen, Gilead, and some smaller firms.
1. Counterfeit drugs are a major global problem that negatively impact public health and pharmaceutical companies. They range from lacking active ingredients to having incorrect dosages and can lead to treatment failure, increased antimicrobial resistance, and even death.
2. India accounts for a large portion of the global counterfeit drug trade due to its large pharmaceutical industry, lack of regulation, and high drug prices. Many counterfeit drugs originate in India and are distributed worldwide.
3. Strategies to reduce counterfeiting include strengthening drug regulation, increasing inspections, consumer awareness campaigns, implementing track-and-trace technologies like barcodes and RFID in supply chains, and harsher penalties for counterfeiters.
The document discusses counterfeit medicine, including its definition, prevalence, consequences, evaluation, and methods to prevent it. It states that counterfeit medicine ranges from having no active ingredients to incorrect ingredients, and affects both developing and developed countries. Evaluation methods include using RFID, barcodes, Raman spectroscopy, and forensic analysis to identify counterfeits. Legislative authorities and improved regulation aim to curb the estimated $90 billion global counterfeit drug industry that causes over 1 million deaths annually.
This document provides an overview of the key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
Pharmaceutical Industry Global & Indianprateek_floyd
The document discusses the global pharmaceutical industry. It provides data showing steady growth in global pharmaceutical sales from 2003-2012, with the US market accounting for the largest share. The top 10 pharmaceutical companies are also listed. R&D spending and trends in major markets like the US, Europe, and Japan are examined. Details are also provided about the large and growing pharmaceutical industries in India and their competitive advantages in generics manufacturing.
Kuwait has a population of 4.1 million and its regulatory authority is the State of Kuwait drug and food control administration. The Kuwaiti pharmaceutical market was valued at $781 million in 2012 and is dominated by imported drugs. Major pharmaceutical companies in Kuwait include the Kuwait Saudi Pharmaceutical Industries Company, Sanofi Aventis, and Yiaco Pharmaceuticals. Registration of pharmaceutical products in Kuwait requires documents such as certificates of pharmaceutical product, price, and GMP as well as stability studies, bioequivalence studies, and clinical data.
This document provides safety information for a mixture called CIPC 300 g/L HN. It contains the following key details:
- The product is a mixture used as a plant growth regulator in agriculture.
- Prolonged or repeated exposure may cause damage to organs and is suspected of causing cancer. It can cause eye, skin and respiratory irritation and an allergic skin reaction.
- Precautions include obtaining special instructions before use, wearing protective equipment, and seeking medical advice if exposed, feeling unwell or experiencing skin or eye irritation. The product is toxic to aquatic life with long lasting effects.
This document summarizes amendments made to Administrative Order 56 s. 1989 regarding rules and regulations on licensing drug establishments and other authorizations in the Philippines. The amendments were made to align drug establishment licensing with recently passed laws, streamline regulatory processes, and promote electronic transactions. Key changes include expanding the scope to various entities involved with pharmaceutical products, defining important terms, and requiring licenses or permits for various activities involving pharmaceuticals.
This document summarizes changes in the global pharmaceutical market, including upcoming drug patent expirations and new drug launches. It finds that blockbuster drug sales make up a large portion of major pharmaceutical company revenues. It predicts that Roche will benefit the most from upcoming drug patent expirations at other companies. The largest growth areas for new drug development are seen as cancer, diabetes, hepatitis C, HIV, and multiple sclerosis. Companies with promising drug pipelines include Roche, GlaxoSmithKline, Biogen, Gilead, and some smaller firms.
1. Counterfeit drugs are a major global problem that negatively impact public health and pharmaceutical companies. They range from lacking active ingredients to having incorrect dosages and can lead to treatment failure, increased antimicrobial resistance, and even death.
2. India accounts for a large portion of the global counterfeit drug trade due to its large pharmaceutical industry, lack of regulation, and high drug prices. Many counterfeit drugs originate in India and are distributed worldwide.
3. Strategies to reduce counterfeiting include strengthening drug regulation, increasing inspections, consumer awareness campaigns, implementing track-and-trace technologies like barcodes and RFID in supply chains, and harsher penalties for counterfeiters.
The document discusses counterfeit medicine, including its definition, prevalence, consequences, evaluation, and methods to prevent it. It states that counterfeit medicine ranges from having no active ingredients to incorrect ingredients, and affects both developing and developed countries. Evaluation methods include using RFID, barcodes, Raman spectroscopy, and forensic analysis to identify counterfeits. Legislative authorities and improved regulation aim to curb the estimated $90 billion global counterfeit drug industry that causes over 1 million deaths annually.
This document provides an overview of the key drug laws in Pakistan, including the Drugs Act of 1976, rules framed under the Act, the DRAP Act of 2012, and the Pharmacy Act of 1967. It summarizes the purpose and some important sections of each law. The Drugs Act regulates drug import, manufacture, storage, distribution and sale. It establishes various regulatory bodies and sets penalties for violations. The rules framed under the Act cover licensing, registration, advertising and other areas. The DRAP Act established the Drugs Regulatory Authority of Pakistan and regulates biologicals, drugs, medical devices and other therapeutic goods. The Pharmacy Act established pharmacy councils and regulates the profession of pharmacy.
Pharmaceutical Industry Global & Indianprateek_floyd
The document discusses the global pharmaceutical industry. It provides data showing steady growth in global pharmaceutical sales from 2003-2012, with the US market accounting for the largest share. The top 10 pharmaceutical companies are also listed. R&D spending and trends in major markets like the US, Europe, and Japan are examined. Details are also provided about the large and growing pharmaceutical industries in India and their competitive advantages in generics manufacturing.
Kuwait has a population of 4.1 million and its regulatory authority is the State of Kuwait drug and food control administration. The Kuwaiti pharmaceutical market was valued at $781 million in 2012 and is dominated by imported drugs. Major pharmaceutical companies in Kuwait include the Kuwait Saudi Pharmaceutical Industries Company, Sanofi Aventis, and Yiaco Pharmaceuticals. Registration of pharmaceutical products in Kuwait requires documents such as certificates of pharmaceutical product, price, and GMP as well as stability studies, bioequivalence studies, and clinical data.
Pipelinepharma is a global online marketplace that directly connects pharmaceutical buyers and sellers to facilitate licensing deals for oncology products. The marketplace lists over 1,376 oncology finished dosages and 1,067 APIs available for licensing, as well as 120 clients seeking in-licensing opportunities. Pipelinepharma aims to make licensing more efficient by removing intermediaries and enabling deals to be made in just a few days through their online platform.
The document summarizes trends in research and development of generic drugs in the global pharmaceutical industry. It provides an overview of historical developments in generic drug maker PLIVA dating back to 1928, and its combination with Barr Group in 2006 to form a global generic pharmaceutical company. It also discusses trends in the generic drug market, strategies for differentiation, and key factors for success in generic drug research and development, emphasizing the importance of speed, intellectual property positioning, and internal API development capabilities.
Sample Chapter Austria for market report “European Pharmaceutical Distribution Fact Book”. The study published by i2k services in August 2009 describes the
European standard pharmaceutical distribution chain with overall channel shares (wholesalers/ DTP/ pharmacy/ hospital/ other).
Furthermore comparable country profiles for the major European markets (France, Germany, Italy, UK) include distribution channel shares, margins and taxes as well as the top wholesaler market shares and pharmaceutical retail landscapes. Regulatory issues regarding pharmaceutical retail (pharmacy ownership, pharmacy chains, internet mail order, etc.) are also highlighted in the country profiles.
The third segment of the report shows the extent of market concentration (European market shares) and the regional footprint of the leading players in the European pharmaceutical wholesale market. Profiles of the top 3 Pan-European wholesalers (PHOENIX, Celesio, Alliance Boots) comprise company overview, business segments, SWOT analysis, growth strategy and some financial data.
The pharmaceutical market of Uzbekistan is growing rapidly due to economic development and population growth. The market is currently estimated at $650-700 million but is forecast to double to $1.5 billion by 2020. Local manufacturers currently hold 20% market share while the remaining 80% is held by foreign manufacturers, primarily from Europe, the US, and India. The government is supporting development of domestic production through incentives for foreign investment. Key growth areas are expected to be generics, OTC drugs, and patented brands as consumer purchasing power increases. The market remains underdeveloped with a need for more modern medical facilities and a wider range of products across the country.
DUPHAT is the premier Pharmaceutical and Technology event in the Middle East launched in 1995 by INDEX® Conferences and Exhibitions Org. Est., a member of INDEX Holding in collaboration with the government through the Dubai Health Authority with the aim to provide a high-quality conference and a wide-ranging exhibition.
DUPHAT is the premier Pharmaceutical and Technology event in the Middle East launched in 1995 by INDEX® Conferences and Exhibitions Org. Est., a member of INDEX Holding in collaboration with the government through the Dubai Health Authority with the aim to provide a high-quality conference and a wide-ranging exhibition.
American Healthcare and Natural Products Expo 2013Via Expo
American Healthcare and Natural Products Expo 2013
27 February - 01 March 2013
Kempinski hotel, Sofia, Bulgaria
Organizer: Via Expo with the support of the Foreign Commercial Service at the U.S. Embassy in Sofia, Bulgaria
The event will give a quick, easy and unsophisticated market entry opportunity and an efficient approach to USA companies, while exhibiting to recruit for potential best prospect agents/distributors and customers for medical, dental, ophthalmologic, laboratory equipment and natural/organic products. This show will give an opportunity to the Bulgarian healthcare community, doctors, researchers, medical equipment distributors, natural products manufacturers and distributors and administrators to better acquaint themselves with the American healthcare market and achievements.
Event website: http://www.viaexpo.com/en/events/american-healthcare-and-natural-products-expo-2013
Organiser: Via Expo
T/F+359 32 960 011, 945 459| E office@viaexpo.com| W www.viaexpo.com
This document discusses self-medication in Croatia, including an overview of self-medication worldwide and in Croatia specifically. It notes that over-the-counter (OTC) drugs make up 27% of drugs used in Croatia by unit. The role of pharmacists is expanding to include health consultation to help patients practice responsible self-medication. Future goals include increasing education of both medical professionals and patients about responsible OTC drug use and the differences between OTC drugs and dietary supplements.
The pharmaceutical industry in India is sized at $5 billion currently ranked 4th in terms of volume and 13th in terms of value, growing at an annual rate of 14.3% and expected to reach $25 billion by 2010. There are over 23,000 pharma companies in India but only around 300 operate in the organized sector. Novartis India is a 51% subsidiary of Swiss company Novartis, established in India in 1996. Novartis India's pharmaceuticals business contributes 62% of its sales and it has grown its total income over the years from 2004-2007 but profitability has been impacted by price regulations in India.
Hiv Drug Distribution in developing countries.hitjl
This presentation is a school work and represents student ideas and analysis ( safe harbor).
Perrine Dieusaert, Malam Aboubakar and I, presented it in January 2009.
The document discusses cooperative enterprises in the pharmacy sector in Belgium. It provides background information on OPHACO, the largest cooperative in the sector made up of 15 consumer cooperatives. The cooperatives cover about 20% of the pharmacy market in Belgium. The document outlines the legislative framework for pharmacies and wholesalers in Belgium and the EU. It also provides statistics on the key actors and market share in the Belgian medicines distribution and dispensation sector. The strengths of the cooperative model are its coordinated organization and economies of scale, though recruiting pharmacists is a challenge. Major cooperative enterprises in the pharmacy sector in Belgium are also listed.
This document summarizes information about the top 15 pharmaceutical companies in the world in 2015. It provides sales figures and rankings for the top 5 selling drugs worldwide from 2014. It also discusses how the "patent cliff" has affected drug makers as major drugs lose patent protection. Additionally, it outlines key factors for the US pharmaceutical industry's success and discusses the growing pharmaceutical industry and market in India.
TO STUDY THE RECALLED DRUG RANITIDINE HYDROCHLORIDES IN DIFFERENT FORMULATIONS. Shantanu Kumar Singh
The document discusses Ranitidine Hydrochloride, a commonly used drug classified as a histamine H2-receptor antagonist. It provides details on Taj Pharmaceuticals, an Indian company that manufactures and distributes Ranitidine in various formulations. The document covers the mechanism of action, indications, contraindications, pharmacokinetics and other clinical information about Ranitidine.
Ervas Pharmaceuticals' mission is to make herbal wellness accessible to everyone and promote the belief that good health should be available to all. The company produces herbal medicines with the goal of improving health and wellness. Ervas focuses on natural and herbal remedies to help more people access affordable healthcare options.
Ervas Pharmaceuticals' mission is to make herbal wellness accessible to everyone and promote the belief that good health should be available to all. The company produces herbal medicines with the goal of improving health and wellness. Ervas focuses on natural and herbal remedies to help more people attain better health.
This document discusses the Drug Regulatory Authority of Pakistan Act (DRAP Act) of 2012 and the role and responsibilities of the Drug Regulatory Authority of Pakistan (DRAP). It provides details on the composition and objectives of DRAP, including regulating pharmaceutical products, medical devices, biological drugs, and controlled substances. It also discusses DRAP's role in registering herbal and alternative medicines, as well as nutraceuticals, dietary supplements, and other health products. The document outlines some of the challenges for pharmacists and technical staff in ensuring compliance with DRAP regulations. It also provides an overview of the global nutraceutical industry and regulations in various countries.
This document provides an overview of various multinational pharmaceutical companies and their products and positioning in diabetes treatment. It summarizes information on major companies like Sanofi, Novo Nordisk, Johnson & Johnson, Pfizer, GlaxoSmithKline, and their diabetes products. It also discusses competitors in key markets like the US, Brazil, Germany, India, Australia and Japan. Major diabetes drugs mentioned include Lantus, Apidra, Januvia, Exubera and various oral medications for type 1 and type 2 diabetes.
SECOF is a European cooperative group owned by pharmacists that operates pharmaceutical wholesalers across 7 European countries. It aims to strengthen independent pharmacist-owned distribution networks and promote pharmacists' role in healthcare. SECOF represents over 27,000 pharmacies and had a total turnover of over 10 billion euros in 2007. It is also a direct member of the Groupment International de la Répartition Pharmaceutique (GIRP), where it works to represent pharmacist cooperatives' interests through lobbying European authorities.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The document discusses the growth of the global generics market from 1998-2008. It notes that major pharmaceutical companies are increasingly entering the generics market as the patents on many brand-name drugs expire. This has led to consolidation in the generics industry as large companies acquire smaller generics producers. The generics market is also shifting production to countries like India and Southeast Asia to take advantage of lower manufacturing costs.
Pipelinepharma is a global online marketplace that directly connects pharmaceutical buyers and sellers to facilitate licensing deals for oncology products. The marketplace lists over 1,376 oncology finished dosages and 1,067 APIs available for licensing, as well as 120 clients seeking in-licensing opportunities. Pipelinepharma aims to make licensing more efficient by removing intermediaries and enabling deals to be made in just a few days through their online platform.
The document summarizes trends in research and development of generic drugs in the global pharmaceutical industry. It provides an overview of historical developments in generic drug maker PLIVA dating back to 1928, and its combination with Barr Group in 2006 to form a global generic pharmaceutical company. It also discusses trends in the generic drug market, strategies for differentiation, and key factors for success in generic drug research and development, emphasizing the importance of speed, intellectual property positioning, and internal API development capabilities.
Sample Chapter Austria for market report “European Pharmaceutical Distribution Fact Book”. The study published by i2k services in August 2009 describes the
European standard pharmaceutical distribution chain with overall channel shares (wholesalers/ DTP/ pharmacy/ hospital/ other).
Furthermore comparable country profiles for the major European markets (France, Germany, Italy, UK) include distribution channel shares, margins and taxes as well as the top wholesaler market shares and pharmaceutical retail landscapes. Regulatory issues regarding pharmaceutical retail (pharmacy ownership, pharmacy chains, internet mail order, etc.) are also highlighted in the country profiles.
The third segment of the report shows the extent of market concentration (European market shares) and the regional footprint of the leading players in the European pharmaceutical wholesale market. Profiles of the top 3 Pan-European wholesalers (PHOENIX, Celesio, Alliance Boots) comprise company overview, business segments, SWOT analysis, growth strategy and some financial data.
The pharmaceutical market of Uzbekistan is growing rapidly due to economic development and population growth. The market is currently estimated at $650-700 million but is forecast to double to $1.5 billion by 2020. Local manufacturers currently hold 20% market share while the remaining 80% is held by foreign manufacturers, primarily from Europe, the US, and India. The government is supporting development of domestic production through incentives for foreign investment. Key growth areas are expected to be generics, OTC drugs, and patented brands as consumer purchasing power increases. The market remains underdeveloped with a need for more modern medical facilities and a wider range of products across the country.
DUPHAT is the premier Pharmaceutical and Technology event in the Middle East launched in 1995 by INDEX® Conferences and Exhibitions Org. Est., a member of INDEX Holding in collaboration with the government through the Dubai Health Authority with the aim to provide a high-quality conference and a wide-ranging exhibition.
DUPHAT is the premier Pharmaceutical and Technology event in the Middle East launched in 1995 by INDEX® Conferences and Exhibitions Org. Est., a member of INDEX Holding in collaboration with the government through the Dubai Health Authority with the aim to provide a high-quality conference and a wide-ranging exhibition.
American Healthcare and Natural Products Expo 2013Via Expo
American Healthcare and Natural Products Expo 2013
27 February - 01 March 2013
Kempinski hotel, Sofia, Bulgaria
Organizer: Via Expo with the support of the Foreign Commercial Service at the U.S. Embassy in Sofia, Bulgaria
The event will give a quick, easy and unsophisticated market entry opportunity and an efficient approach to USA companies, while exhibiting to recruit for potential best prospect agents/distributors and customers for medical, dental, ophthalmologic, laboratory equipment and natural/organic products. This show will give an opportunity to the Bulgarian healthcare community, doctors, researchers, medical equipment distributors, natural products manufacturers and distributors and administrators to better acquaint themselves with the American healthcare market and achievements.
Event website: http://www.viaexpo.com/en/events/american-healthcare-and-natural-products-expo-2013
Organiser: Via Expo
T/F+359 32 960 011, 945 459| E office@viaexpo.com| W www.viaexpo.com
This document discusses self-medication in Croatia, including an overview of self-medication worldwide and in Croatia specifically. It notes that over-the-counter (OTC) drugs make up 27% of drugs used in Croatia by unit. The role of pharmacists is expanding to include health consultation to help patients practice responsible self-medication. Future goals include increasing education of both medical professionals and patients about responsible OTC drug use and the differences between OTC drugs and dietary supplements.
The pharmaceutical industry in India is sized at $5 billion currently ranked 4th in terms of volume and 13th in terms of value, growing at an annual rate of 14.3% and expected to reach $25 billion by 2010. There are over 23,000 pharma companies in India but only around 300 operate in the organized sector. Novartis India is a 51% subsidiary of Swiss company Novartis, established in India in 1996. Novartis India's pharmaceuticals business contributes 62% of its sales and it has grown its total income over the years from 2004-2007 but profitability has been impacted by price regulations in India.
Hiv Drug Distribution in developing countries.hitjl
This presentation is a school work and represents student ideas and analysis ( safe harbor).
Perrine Dieusaert, Malam Aboubakar and I, presented it in January 2009.
The document discusses cooperative enterprises in the pharmacy sector in Belgium. It provides background information on OPHACO, the largest cooperative in the sector made up of 15 consumer cooperatives. The cooperatives cover about 20% of the pharmacy market in Belgium. The document outlines the legislative framework for pharmacies and wholesalers in Belgium and the EU. It also provides statistics on the key actors and market share in the Belgian medicines distribution and dispensation sector. The strengths of the cooperative model are its coordinated organization and economies of scale, though recruiting pharmacists is a challenge. Major cooperative enterprises in the pharmacy sector in Belgium are also listed.
This document summarizes information about the top 15 pharmaceutical companies in the world in 2015. It provides sales figures and rankings for the top 5 selling drugs worldwide from 2014. It also discusses how the "patent cliff" has affected drug makers as major drugs lose patent protection. Additionally, it outlines key factors for the US pharmaceutical industry's success and discusses the growing pharmaceutical industry and market in India.
TO STUDY THE RECALLED DRUG RANITIDINE HYDROCHLORIDES IN DIFFERENT FORMULATIONS. Shantanu Kumar Singh
The document discusses Ranitidine Hydrochloride, a commonly used drug classified as a histamine H2-receptor antagonist. It provides details on Taj Pharmaceuticals, an Indian company that manufactures and distributes Ranitidine in various formulations. The document covers the mechanism of action, indications, contraindications, pharmacokinetics and other clinical information about Ranitidine.
Ervas Pharmaceuticals' mission is to make herbal wellness accessible to everyone and promote the belief that good health should be available to all. The company produces herbal medicines with the goal of improving health and wellness. Ervas focuses on natural and herbal remedies to help more people access affordable healthcare options.
Ervas Pharmaceuticals' mission is to make herbal wellness accessible to everyone and promote the belief that good health should be available to all. The company produces herbal medicines with the goal of improving health and wellness. Ervas focuses on natural and herbal remedies to help more people attain better health.
This document discusses the Drug Regulatory Authority of Pakistan Act (DRAP Act) of 2012 and the role and responsibilities of the Drug Regulatory Authority of Pakistan (DRAP). It provides details on the composition and objectives of DRAP, including regulating pharmaceutical products, medical devices, biological drugs, and controlled substances. It also discusses DRAP's role in registering herbal and alternative medicines, as well as nutraceuticals, dietary supplements, and other health products. The document outlines some of the challenges for pharmacists and technical staff in ensuring compliance with DRAP regulations. It also provides an overview of the global nutraceutical industry and regulations in various countries.
This document provides an overview of various multinational pharmaceutical companies and their products and positioning in diabetes treatment. It summarizes information on major companies like Sanofi, Novo Nordisk, Johnson & Johnson, Pfizer, GlaxoSmithKline, and their diabetes products. It also discusses competitors in key markets like the US, Brazil, Germany, India, Australia and Japan. Major diabetes drugs mentioned include Lantus, Apidra, Januvia, Exubera and various oral medications for type 1 and type 2 diabetes.
SECOF is a European cooperative group owned by pharmacists that operates pharmaceutical wholesalers across 7 European countries. It aims to strengthen independent pharmacist-owned distribution networks and promote pharmacists' role in healthcare. SECOF represents over 27,000 pharmacies and had a total turnover of over 10 billion euros in 2007. It is also a direct member of the Groupment International de la Répartition Pharmaceutique (GIRP), where it works to represent pharmacist cooperatives' interests through lobbying European authorities.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
The document discusses the growth of the global generics market from 1998-2008. It notes that major pharmaceutical companies are increasingly entering the generics market as the patents on many brand-name drugs expire. This has led to consolidation in the generics industry as large companies acquire smaller generics producers. The generics market is also shifting production to countries like India and Southeast Asia to take advantage of lower manufacturing costs.
Similar to Serbia - Farmaceutico, biotecnologie (20)
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
«Attrazione di investimenti mediante sostegno finanziario, in grado di assicurare una ricaduta sulle PMI a livello territoriale" – sub-azione: "Attrazione produzioni cinematografiche e azioni di sistema attraverso il sostegno delle PMI che operano direttamente o indirettamente nel settore" dell'Asse prioritario 3 – Competitività»
RIUSA - Presentazione Prof. Massimiliano BarlettaLazio Innova
Valorizzazione di scarti di produzione nella manifattura di una gamma di imballaggi “intelligenti” in plastica di bio-derivazione compostabile, termostabile, autoprotetta ed idonea al contatto prolungato con alimenti
Investimenti per la riqualificazione energetica del patrimonio immobiliare pubblicoLAZIO GREEN – IL FUTURO SOSTENIBILE
Investimenti per la riqualificazione energetica del patrimonio immobiliare pubblico
1. PHARMACEUTICAL SECTOR OF SERBIA
Vekoslav Šošević, Secretary of Association of Chemical and
Pharmaceutical Industry, Rubber and Non-Metal Industry
25 th October 2012, Rome
2. PHARMACEUTICAL INDUSTRY - ECONOMIC OVERVIEW
Share of pharmaceutical sector in GDP - 0,7%
Gross production of the industry - over 450 mil. Euro (2011)
Total consumption of medicines in Serbia - 740 mil. Euro
Annual production rate ~10%
Number of employees - 7000
Export oriented (155 mil Euro of goods were exported in 2011)
Direct contribution to the budget of the Republic of Serbia (2011) ~40 mil. Euro (taxes,
contribution, customs)
3. TRADE FLOW OF DOMESTIC PRODUCERS FROM SERBIA IN 2011
For years, domestic pharmaceutical industry has been a carrier of stable supply of the market with
medicines of all forms and dosages
Total consumption of medicines in Serbia for 2011 is estimated to around 740 mil. Euros. Share of
imported medicines is 370 mil. Euros
According to number of boxes of medicines sold: domestic producers supply the market with
around 75% of medicines, reaching around 45% of the cash flow (this difference is caused by the
difference in price of domestic medicines which is significantly lower than the price of imported
medicines)
4. TRADE FLOW OF MEDICINES IN SERBIA IN 2011
Hemofarm A.D.
Galenika A.D
Zdravlje A.D.
F.Hoffmann-La Roche LTD.
Glaxosmithkline SPA
Pfizer H.C.P. Corporation
21% 26% Sanofi-Aventis S.P.A.
1% Novo Nordisk A/S
1% 1% SERBIAN Alkaloid A.D.
1% Jugoremedija A.D.
Krka Tovarna Zdravil D.D.
1% 1% Bristol-Myers Squibb
Pharmaswiss D.O.O.
2% Novartis Pharma AG
2% 13%
2% 6% Ferring international center SA
2% 2% 3% 3% 3% 4% Schering AG
Janssen-Cilag International N.V.
2% 2% Astra Zeneca UK Limited
Merck Sharp & Dohme BV
Habit Pharm A.D.
Ostalo
5. TRADE BALANCE
Export of medicines in 2011 was 208,3 mil. dollars (index for 2011 / 2010 was109)
The highest export was in Russian Federation (50 mil.), Germany (40 mil.), Montenegro, Bosnia
and Herzegovina, Bulgaria, Macedonia
Export in Italy was 2,2 mil. dollars in 2011
We believe that opportunities are a lot bigger
Import of medicines was (mostly from EU): it is growing on yearly basis - export in 2011 reached
525,9 mil USD (index for 2011 / 2010 was 101)
The highest import was from Germany (99 mil.), France (76 mil.), Italy 47 mil. USD, Great Britain 30
mil. Denmark, etc.
6. TRENDS IN IMPORT AND EXPORT OF MEDICINES IN SERBIA (CARTAR 3003, 3004)
SERBIAN
8. OWNERSHIP STRUCTURE
Privatized companies Non-privatized companies
Hemofarm - Stada Nemačka Galenika Zemun - 2400 employees
Zdravlje - Actavis Island Institute for Immunology and Virology Torlak -
Pharmaswiss Švajcarska 400 employees
Alkaloid Makedonija Jugoremedija - 450 employees
SERBIAN
Pharmanova
Slaviamed
Ivančić i sinovi
Participation of Italian companies is expected in process of privatization of not privatized companies
(Galenika, Torlak, Jugoremedija)
9. PRESENCE OF FOREIGN COMPANIES
The Highest number of multinational companies are present today in Serbian market through
import and licensed products or through market agreements with domestic companies
Around 70 foreign pharmaceutical companies have its representative offices in Serbia
Table 1 Table 2
ТОР10 foreign manufactures in Serbia pharmaceutical ТОР10 foreign manufactures in Serbia pharmaceutical market ( by
market ( by share in value terms), Q3SERBIAN
2011 share in real terms), Q3 2011
10. ITALIAN COMPANIES PRESENT IN SERBIA
ABBOT S.R.L. MERCK SHARP & DOHME S.P.A.
ACTAVIS ITALY S.P.A. NOVARTIS FARMA S.P.A.
BAYER HEALTHCARE PFIZER ITALIA S.R.L.
MANUFACTURING S.R.L. PHARMATEX ITALIA SRL.
CATALENT ITALY S.P.A. ROTTAPHARM S.P.A.
DOMPE PHARMA S.P.A. SERBIAN
SIGMAR ITALIA S.P.A.
ELI LILLY ITALIA S.P.A. ZAMBON S.P.A.
FRESENIUS KABI ITALIA S.R.L.
GLAXOSMITHKLINE SP
HAUPT PHARMA LATINA
ISTITUTO DE ANGELI S.R.L
LABORATORI BALDACCI S.P.A.
MERCK SERONO S.P.A.
11. DISTRIBUTION OF MEDICINES
Distribution of medicines in Serbia is done through wholesalers
75 % medicines and medical devices are done through 17 wholesales gathered in
group of wholesalers with around 2500 employees
All wholesalers meet the requirements specified in the Book of rules on conditions for
wholesale of medicines and medical devices, and the majority of its members conduct
SERBIAN
their business with implemented ISO quality standards
Following link in supply chain of medicines in Serbia are pharmacies (state and
privately owned)
12. AGENCY FOR MEDICINES AND MEDICAL DEVICES OF SERBIA
Issues permits for medicines
Registers medical devices in the Register of Medical Devices
Conducts a registration of traditional herbal medicines
Issues permits for clinical testing of medicines and medical devices
Performs control of clinical testing
Issues certificates for export of medicines and medical devices
SERBIAN
Approves import of medical devices for patient’s needs
Approves import of medicines for scientific testing
Controls the quality of medicines and medical devices
Participates in development of regulations and national policy in the field of medicines and medical
devices
13. PROCEDURE FOR MEDICINES REGISTRATION
Agency for medicines and medical devices
In Serbia, a permit for medicine can be given to:
A producer that has a permit to produce medicines in the Republic of Serbia
Representative of foreign producer that has headquarters in the Republic of Serbia
Representative of foreign legal entity that is not a producer of that medicine but has a permit for
SERBIAN
that medicine in the countries of the EU or in countries that proscribe same requirements for
permits issuance as that of the Republic of Serbia
Legal entity with headquarters in the Republic of Serbia that received a permit for the medicine
from a producer in Serbia, that is that provided him with conditions to become a receiver of the
medicine permit from their own production program
Medicine permit is being renewed every five years, and after risk and benefits evaluations have
been made
14. ACCESSIBILITY VS AVAILABILITY
Who is responsible for access and availability of medicines?
Accessibility AVAILABILITY
Government
SERBIAN Producers
Health Insurance Fund Wholesalers
Regulatory bodies (AMMD, Ministry of Health institutions (pharmaceutical
Health and Ministry of Trade) institutions, pharmacies, hospitals)
15. REGULATIONS
Law on Medicines and Medical Devices (Official Gazette of RS no. 30, May 7th, 2010)
Subact
Regulation on conditions for trade with medicines and medical devices (Official Gazette of RS no. 27
March 17th , 2008)
Guidelines for Good practice in Distribution of Medicines (Official Gazette of RS no. 28, March 18th
2008)
SERBIAN
Regulation on conditions for import of medicines and medical devices which do not have a permit to
be distributed (Official Gazette if RS no. 37, April 11, 2008)
Book of rules on amendments and remarks, Book of rules on content and inner and outer labeling of
medicine packaging and on patient’s /user’s instructions (Official Gazette RS 104, December 16 th
2009)
Regulation on Medical Waste Management (Official Gazette of RS no 78, October 25th 2010)
16. CONCLUSION
Advantages
Serbia has a status of potential candidate for EU membership
Economy of the country needs significant investments in domestic pharmaceutical sector
A lot more stable conditions for FDI and domestic development
Good economic and political cooperation with Russia provide access to this big market
SERBIAN
Opportunities
Gradual integration in EU and future membership should provide quicker reforms
Privatization and modernization of domestic pharmaceutical producers provide higher chances for
export
Investments and improvements of healthcare program will be promoted by the Government
Shortened procedures for registration of generics for both foreign and domestic producers
17. THANK YOU FOR YOUR
ATTENTION!
phone: + 381 63 3233 671
cell: + 381 63 336 743
e-mail: vekoslav.sosevic@pks.rs
www.pks.rs