Education

advertisement
International
Medical Products
Anti-Counterfeiting
Taskforce
Map of Seychelles
Introduction
• Seychelles consists of about 115 islands
situated in the western Indian ocean
• The major islands of Seychelles are located
1000 miles (1600 km) east of Kenya
• The main islands are Mahe, Praslin and La
Digue. The capital is Victoria
• Seychelles has a population of about 85000
Introduction Cont.,
• The total area of Seychelles islands are 175
square miles (453 square km)
• The climate is tropical oceanic with little
temperature variation during the year.
Education
• School system is free for the nine year of
primary and secondary education
Health System
•
•
•
•
Health is free
Seven private doctors with dispensing facilities
Four private pharmacies and few health care shops
Majority of medicines are distributed by Government
pharmacies
• Medicines imported by Ministry of Health (MOH) are
tested during pre-marketing and post marketing
surveillance by National Drug Quality Control
Laboratory (NDQCL)
• The NDQCL was established in 2001
Health System Cont.,
• Medicines imported by MOH are mainly generic
items whereas private pharmacies mostly target
branded items
• MOH buys its medicines directly from the
manufacturers for export
• There is only one International Air port and most
medicines imported by MOH comes via air
• Private pharmacies target parallel market
• Medicines imported by Private or NGO’s are not
tested at NDQCL due to lack of Legislations
Definition of counterfeit
medical product used in
Seychelles
• In the past years there were no seizure of
counterfeit medicines
– No Legislation in place
– Inadequate drug registration system
– Absence of CM in the country
Seychelles is not aware of the WHO’s Rapid Alert
System
Our National Legislation
• Seychelles Pharmacy Act is outdated
• Currently we are in the process of getting the
WHO’s consultants to review the National
Medicine Legislation and Regulatory
Framework
• In the new Pharmacy Legislations, the
following be in cooperated:
Definition of CM, Cooperation
between national authorities and stake holders, Regional and International
cooperation, Strengthening the operational capacity of the medicines
regulatory authority, Criminalizing the trade of CM and more severe
sanctions for crimes related to CM
National coordination
• There is a Medicines Regulatory Authority (MRA) unit within
the Pharmaceutical Services under the MOH
Only issues permits for private and NGO’s for importing
medicines
Inspection of Pharmacy premises together with licensing
authority
No registration of medicines
• Public sector uses open permit system for importing
medicines and its renewed annually
• For the year 2007, MRA issued
 655 permits to private sectors
 5 permits to NGO’s
Free Trade Zone
• In Seychelles the free trade zone is only for
export market
• The free trade zone are under the supervision
of MRA but inadequate human resources
makes it difficult to supervise frequently
• The National Pharmaceutical Legislations is
applicable for the free trade zone
• In 2008, there were two pharmaceutical
inspections carried out
Market Control
• In 2007, the total number of samples collected
from public sector were 313
• All the 313 samples were tested at NDQCL
• There are no informal market for medicines in
Seychelles
Number of cases
Suspected
Confirmed
Imported / Domestic
Vital Medicines
2008
2007
2006
2005
How where these cases detected?
number of cases
Patients complaints
Health professionals reports
Enforcement/investigation work
Routine checks
Reported by affected manufacturer/importer
Other
Conclusion
• So far MOH has not encountered with
Counterfeit Medicines
• Possibly in private sectors counterfeit
medicines may exist
• Nothing could be done until the National
Medicine Legislation and Regulatory
Framework is established
• Seychelles will support any proposal that will
help to combat counterfeit medicines
Download
Related flashcards

Space program of Japan

36 cards

Wiki communities

69 cards

Create Flashcards