1. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products FALSIFIED MEDICINAL PRODUCTS Mira Kontic senior advisor for legislation Ministry of Health

2. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products LEGAL BASIS ●Law on medicines and medical devices (OG RS No. 30/2010, 107/2012) ●Rulebook on content and mode of labeling Outer and Immediate Packaging, additional labeling and content of Patient Information Leaflet (OG RS No. 41/2011) ●Good Manufacturing Practice (OG RS No. 28/2008 and 86/2010) ●Rulebook on content of Certificate on application of Good Manufacturing Practice Guidelines (OG RS No. 100/2011) ●Rulebook on quality control of medicines and medical devices (OG RS No. 64/2011 and 63/2013)

3. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products FALSIFIED MEDICINAL PRODUCT LAW FROM 2010 - DEFINITION ●Counterfeit medicinal product is a one produced/placed on the market, and/or is already on the market with the intention of misleading the entities using it, or in any way handling the medicinal product, and that has counterfeit data about: o identification (manufacturer, place of production, marketing authorization holder, certificate of analysis, as well as other data and documentation concerning the medicinal product)

4. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products FALSIFIED MEDICINAL PRODUCT/DEFINITION o that can contain right or wrong ingredients in accordance with the declared composition o and/or not to contain active substances, or the sufficient quantity of active substances o counterfeit packaging, as well as other medicinal product that is considered to be counterefit by the standards of the EU and WHO

5. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products ACTIVE SUBSTANCE/EXCIPIENT DEFINITION ●any substance/a combination of substances used in medicinal product production and thus becoming an active ingredient of the product, whose aim is to affect the pharmacological activity or directly affects diagnostics, treatment, relief, care, disease prevention or the structure or functions of an organism ●a substance used in medicinal product production. Since not being its active substance it aids pharmaceutical shaping of the medicine, protects, promotes and improves stability, biological availability and medicinal product tolerance, as well as, helps to identify the medicinal product

6. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products AUTHORIZATION AND PROHIBITIONS ●Manufacturing/Wholesale authorization issued by the MoH – Inspection for medicines and medical devices ●Prohibition regarding counterfeit medicinal products Article 109 - manufacturing Article 134 - sale Article 135 - Competent Ministry must prohibit and order withdrawal of medicinal products if it is an counterfeited

7. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products GOOD MANUFACTURING PRACTICE ●GMP is a part of quality assurance that enables consistent production and control in accordance with the quality standards and requirements from marketing authorization and/or product specification. ●Good control laboratory practice is a part of GMP on the basis of which a medicine quality control is performed ●GMP Guidelines are a system of quality assurance referring to quality of medicinal products manufacturing organization, quality control and monitoring. Guidelines on the GMP for active substances are a part of GMP

8. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products MA - GMP ●Application for marketing authorization also contains administrative data – Certificate of the GMP, issued by the Ministry or the appropriate certificate of the European Union or another country that has the same or similar requirements like in the EU regarding GMP - Article 29 ●Rulebook on content of Certificate – it contains date and results of inspection ●Register of manufacturers/wholesalers – Article 104 and 124 ●Sale of medicines over internet is forbidden

9. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products LABELING ●Outer packaging and immediate packaging of a medicinal product that is at the same as the outer packaging has to be labelled in the Serbian Cyrillic, as well as in the Latin, in accordance with the marketing authorization and the Summary of Product Characteristics - Article 153 ●Data written on the outer and immediate packaging have to be legible, comprehensible and undeletable ●Substance/combination of substances have to be labelled ●Control mark, NBS – Institute for production of paper and coin money (serial number, hologram, bar code)

10. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products REPORT SUSPICIONS OF FAKE MEDICAL PRODUCTS TYPES OF NOTIFICATIONS Sale of counterfeits and unregistered medical products over the internet and mobile phone – irregular supply chain Sale trough advertisement in newspaper From manufacturers whose medicine is counterfeited From manufacturers whose medical devices name is counterfeited At the pharmacy – purchase outside of the regular supply chain Sales of supplements that are banned or contains undeclared substances

11. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products NOTIFICATIONS IN 2013 1.Patients, customers 2.Health officer 3.Manufacturers 4.Foreign manufacturers by representative 5.Police, Department of combating high-tech crime 6.Police, Department of combating economic crime 7.Customs 8.Coordination Team Operation Pangea VI 9.Rapid Alert Notification 10. MoH, inspectors for medicine and medical devices 11. Anonymous report

12. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products Submission of doubt about the quality, i.e. deviation from the standard of quality Number of report: Ministry of Health, Nemanjina st 22-26, 11000 Belgrade Telephone Class of deviation from quality standards (round off) I II III fake medicine Type of product (round off) Medicine Medical device Name of product:Pharmaceutical form: Intensity:Type and size of packaging: Number of series:Expiration date: Holder of medicine, or the holder of the entry of registration med. devices in the register Manufacturer: Description of the observed deviations from quality standards: Date and time of the observed deviations from quality standards: Number of available samples:Health facility where the medicine was administered: Measures taken in relation to the patient: Name, surname, phone number of reporting person of the observed deviations from quality standards: Signature of the reciver of report: Date of reporting:Time of reporting:

13. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products Inspection for Medicines and Medical Devices Notification/ Regular supervision InspectionTaking a sample National Control laboratory ALIMS Lab report Withdrawal from the market Police Prosecution Customs Media

14. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products MoH ACTIVITIES ●Initiative and nomination of SPOC contact persons, EDQM model - form health, police, customs and prosecution ●Mechanisms for exchange of information ●Meetings with national institutions and manufacturers/marketing authorization holders ●System of preparing Yearly report on counterfeits ●Rapid alert notifications – RAN ●Inspectors activities – forbidding market and withdrawal, extraordinary control of quality

15. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products Counterfeit medicines in 2013

16. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products FIGHT AGAINST COUNTERFEITS MoH Inspection for medicines and medical devices Police High technology crime Customs Police Economic crime Intellectual Property Office Manufacturers of medicines and medical devices Wholesalers and importers Inspections sanitary, health, market, financial Prosecution Representative of the foreign manufacturers National control laboratory ALIMS User, customer, patients

17. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products ADMINISTRATIVE CAPACITY MINISTRY OF HEALTH ●Group for medicines and medical devices (regulatory and pricing) o 3 employees (2 М.Sc. Pharm and 1 М.Sc. Law) ●Inspection for medicines and medical devices o 9 employees (9 М.Sc. Pharm)

18. Serbia Chapter 28 – Consumer and Health Protection Medicinal Products FUTURE PLANES ● Harmonization with Directive 2011/62/EU ● New GDP ●Harmonization with rules not implemented fully in 2010 and new EU legislation (after 2010) and amended ones

19. Thank you for your attention! mira.kontic@zdravlje.gov.rs mira.kontic@zdravlje.gov.rs