Complaint

Complaint number
NTB-000-940  
NTB Type
5.14. Restrictive licenses  
Complaint
The newly introduced Rwanda FDA is a double registration and a violation to EAC originating products with standardization quality marks for mutual recognition.
Rwanda FDA was never notified to Kenya/EAC
This will mean products going through double registration/approval systems in EAC. Rwanda to consider exempting EAC products from FDA

These are stringent new requirements on the EAC Community Products:
- when you want to import you need to request for import license, we no longer export/import from EAC, therefore when products have quality standardization mark it serves as one of documents to prove the safety of the products.
- You will also need to provide the product invoice and batch test reports to get the import license, before a products is issued with SMark it must be tested and confirmed that it conforms to the EAC products certification therefore this requirements should be exempted from locally manufactured products with quality marks and Certificate of Origin.
- Registration of the products: it is now mandatory to have the products registered have unique Smark numbers. Authenticity of products can be obtained online on the National bureaus.
- Registration fee will make locally manufactured products noncompetitive.  
Status note
During the RMC meeting the Republic of Rwanda informed that, In addressing such related and persistent NTBs, the EASC in 2018 directed the QATSC to develop a Framework for inter agency regulatory control of food and cosmetics to facilitate cross border trade of these commodities. The final framework was recommended by the EASC for SCTIFI approval in their next meeting and this if Partner States commit to implement will reduce the cost of doing business arising among others from re - registration and re- testing . In respect to the Rwanda FDA, the issue was brought to the attention of the Extraordinary meeting of the EASC held on 12th June 2020. The QATSC was directed to discuss the matter and report in the next EASC meeting held on 23rd July with participation of most Partner States Regulatory Authorities .In that meeting Rwanda FDA reported that they recognize products with the EAC notified Quality -Marks that are issued based on harmonized EAC standards, and what Rwanda FDA was doing was just the listing for such products in building the database. The Registration fees for EAC products is waived and EAC products will be registered automatically. The information is on the website and the the Regulations are attached.The NTB is hence resolved.  
Progress update note
Dear Monica

can we have progress report from the NMC meeting on this NTB  
Policy or regulatory NTB
Yes 
Location
Rwanda: Rwanda FDA (Government institution)  
Reporting Country or Region
Kenya  
Country specific trade issue
No  
Date of incident
2020-01-09  
Status
Resolved  
Date of resolution
2020-09-01  
Product Description
All products  
Total value
0  
Date reported
2020-02-20 15:59  
Modified
2020-09-01 17:00