east african community - ifpma€¦ · the east african community (eac) joint assessment procedure...
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SOUTH SUDAN
UGANDA
RWANDA
TANZANIA
KENYA
BURUNDI
Transparency, efficiency and predictability
Efficient administrative team for the management of applications and queries
Single point of Contact in submission of dossiers
Only 1 submission to all EAC National Regulatory Agencies (NRAs) = access to minimum 2 markets and up to 5
Faster and harmonized regulatory approvals in the region
Final decision valid in all EAC Partner States NRAs
Enhance timely access to medicinal products in EAC countries
Reduction of cost for all parties
The East African Community (EAC) Joint Assessment Procedure (JAP) is aninitiative aimed at having joint assessment of applications and harmonized regulatory approvals in the region. The process is available to any industry applicants to register different types of pharmaceutical products across the EAC region through a single application. The procedure also allows for fast track registration of certain medicines.
East African CommunityOne people, one destiny
JUMUIYA YA AFRIKA MASHARIKI
WHY APPLY VIA THE EAC JOINT ASSESSMENT PROCEDURE
JOINT ASSESSMENT PROCEDUREEAST AFRICAN COMMUNITY
International Federationof PharmaceuticalManufacturers & Associations
D A Y 0
1D A Y 1 0
2
5.1 Send List Of Questionsto applicant
5.2 Responses to List Of Questions
E X T R A 1 8 0 D A Y S
3.1 Joint GMP Inspection
D A Y 4 5
3 Initial review
D A Y 3 6 0
8 Approval at National Level and issuance of Marketing authorisation certificates within 90 days
i f physical inspection is necessary
9 Publication of Marketing Authorisations by all NRAs and EAC Secretariat.
OVERVIEW OF THE PROCESS
APPLICANT Uganda NDATanzania Medicines andMedical Devices Authority (TMDA)
ALL NRAs NRA 1 EAC SECRETARIATNRA 2
D A Y 6 5
4 Peer review
D A Y 2 7 0
6 EAC Secretariat
D A Y 3 0 0
7 Issuance of the final EAC recommendation for registration. Confirmation letter is sent to applicant
D A Y 9 0
5 Assessment Session
maximum 3 rounds (each round = 180 extra days)
Applicable fees for EAC Partner States NRAs are available upon request.
ACTORS
Do you have further questions?
Would you like to submit an application for a product through the EAC Joint Assessment Procedure?
Please reach out to the EAC Secretariat for further assistance.
MORE INFORMATION
East African CommunityOne people, one destiny
JUMUIYA YA AFRIKA MASHARIKI
Tel: +255-27-2162100/14
Email: [email protected]
Screening and validation by TMDA. Verification of GMP status
Tanzania Medicines and Medical Devices Authority
Application submission to
Review followed by Joint Compile documents and send recommendations to
led by Uganda National Drug Authority (GMP lead)