Nairobi 04/09/2017….. The Kenya Bureau of Standards (KEBS) and Pharmacy and Poisons Board (PPB) have formed a partnership which will see all imported medical devices, food supplements, medical cosmetics, and herbal products inspected under the Pre-Export Verification of Conformity (PVoC) to Standards programme.
The new guideline, will kick off on September 1st and is aimed at protecting the public against imported pharmaceutical products that do not comply with local quality standards and technical regulations.
The joint effort between the two organizations is aimed at leveraging KEBS’ PVoC programme which inspects imported goods at the country of origin before they arrive in the country for sale/distribution.
The Pharmacy and Poisons Board (PPB) is the National Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244, the Laws of Kenya. PPB is mandated to regulate the Practice of Pharmacy and the Trade in Drugs and Poisons. KEBS is mandated to offer, among other services, quality inspection of imports based on Kenya Standards or approved specifications.
With this guideline, products and other allied healthcare borderline products falling under the regulated mandate of Pharmacy and Poisons Board must comply with the Pre-Export Verification of Conformity (PVoC) to Standards programme implemented by KEBS.
According to a notice by KEBS and PPB, the importers of medical devices, food supplements, medical cosmetics, herbal products must obtain Certificates of Conformity (CoC) for their cargo before applying for Import Permits from Pharmacy and Poisons Board through the Kenya National Single Window Electronic (Kentrade) System.
Please find below more information on the new guidelines
- Pharmaceutical Manufacturers licensed by the Pharmacy and Poisons Board importing Raw Materials, Machinery and Spares for own use are exempted from the above requirements as outlined in PVoC manual on KEBS website (www.kebs.org).
- Licensed Pharmaceutical Manufacturers are encouraged to obtain PVoC Exemption Certificate from KEBS in order to facilitate clearance of their cargo.
- All imported goods arriving at port of entry without CoC will be subjected to destination inspection by KEBS upon payment of destination fees as provided for under Legal Notice No. 78.
About Pre-Export Verification of Conformity (PVoC) Programme
PVoC Program is a conformity assessment procedure applied at the country of supply on certain products to ascertain their compliance with applicable Kenya Standards or approved specifications before shipment. The program is based on Legal Notice 78 of 15/ 07/2005.
Objectives of the program
- Protects the public by ensuring products not meeting safety and quality requirements are stopped at source
- Protection of the environment by ensuring the country is not a dumping ground for hazardous goods and obsolete equipment
- Provision of cost effective process in the implementation of standards by ensuring quality inspection procedures are in harmony with modernized programmes undertaken by other major stakeholders e.g. Kenya Revenua Authority and Kenya Ports Authority among others
- Minimizing cargo clearance turnaround times at the port of entry