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How to Register Food/Dietary Supplements in Kenya

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How to Register Food/Dietary Supplements in Kenya by Kenyans247(1): Sat 14, March, 2020 03:51pm
Procedure
To register food/dietary supplements, the applicant has to contact the http://pharmacyboardkenya.org/?page_id=99 Pharmacy and Poisons Board offices].
Applicants are requested to carefully read the Guidelines on registration of Food/Dietary Supplements, fill in application form, prepare dossiers and submit them in one (1) hard-copy as well as an electronic copy (MS Word on a CD-ROM) which should be cross-referenced to the dossier by clearly indicating the title and section number of all the supporting documents.
The applicant has to make sure he or she has all the required documents that are required for this process to be successful and it can be found under the "Required Documents" section of this page or in the Guidelines on registration of Food/Dietary Supplements.
Payment of appropriate fees should be made and that can be found under the "Fees" section of this page or at Guidelines on registration of Food/Dietary Supplements fees section.
On completion of this process, the applicant will be given feedback by the Board.
The Board will implement the following timelines in processing applications:
Fast-tracked registration (Locally manufactured and Priority products only), Post Approval Variation and Renewal of registration
Completed applications will be processed within 90 working days of receiving the application including evaluation of documentation and consideration by the board.
Evaluation of new applications
Complete new applications will be processed within 6 months of receipt of the application.

Required Documents
One duly filled application form and an electronic copy in MS Word on a CD-ROM including their supporting documents
Three (3) samples of the smallest commercial pack(s) from one batch with batch certificates of analysis.
Non refundable application fee for registration of food/dietary supplements and borderline products in Kenya.
GMP inspection of the manufacturing site may be required in case of quality issues in the market

Office Locations & Contacts
The Registrar

Pharmacy and Poisons Board
Lenana Road Opp. DOD

P.O. Box 27663 00506

Nairobi

Telephone:
+254 702 475 824 (8am-5pm) Online Licensing
+254 702 475 845 (8am-5pm) Online Licensing
+254 702 475 837 (8am-5pm) Online Licensing
+254 702 475 842 (8am-5pm) Online Licensing
+254 702 475 801 (8am-5pm) Online Licensing
+254 20 3562107 General Line
+254 720 608811 General Line
+254 733 884411 General Line

Email:
General Enquiries: enquiries@pharmacyboardkenya.org
Pharmacy Questions: info@pharmacyboardkenya.org
Report a Medicine Problem: pv@pharmacyboardkenya.org

Website: http://pharmacyboardkenya.org

Map Location https://www.google.com/maps/place/Pharmacy+and+Poisons+Board,+Kenya

Eligibility
Application for registration of a Dietary/Food Supplement and borderline products shoudl be made only by:

the patent holder
the manufacturer
a distributor or Local Representative authorised by the manufacturer or patent holder


Fees
Products imported into Kenya US$ 1000
Locally manufactured in Kenya US$ 500
GMP inspection fee for foreign Companies US$ 4000
GMP inspection fee for Local Companies US$ 1000


Validity
The registration of food/dietary supplements and borderline products shall be valid for one (1) years unless earlier suspended or revoked by PPB or withdrawn by applicant.

The Board will give reasons in writing when it suspends or revokes, or amends conditions of registration.

Likewise, the applicant shall also give reasons for terminating registration of a food/dietary supplement and borderline products.

Documents to Use
Application Form For Registration Of Food/Dietary Supplements http://pharmacyboardkenya.org/downloads/?file=food_sipplement_application.pdf

Processing Time
a) Fast-tracked registration (Locally manufactured and Priority products only), Post Approval Variation and Renewal of registration

Complete applications will be processed within 90 working days of receiving the application including evaluation of documentation and consideration by the board.

b) Evaluation of new applications

Complete new applications will be processed within 6 months of receipt of the application.

Instructions
A product is considered as a food supplement if it contains the Recommended Dietary Allowances (RDA) as given in annex I and international standards. It is intended to provide an appropriate format for submission of data for registration. Applicants should not modify the overall organization of the document as outlined in the guideline.

All applications and supporting documents should be in English or Kiswahili and legible. Where material is not originally in English or Kiswahili, a copy in the original language and a full translation should be submitted, the accuracy of which is the responsibility of the applicant.

Authentication of the translation has to be done at the nearest Kenyan Embassy or by the national drug regulatory authority of the country from where the document originates. Reports submitted only in a language other than English or Kiswahili will not be accepted.



Required Information
The name, physical address, telephone number, fax number, and e-mail address of the applicant
Particulars of the dietary/food supplement product
Proprietary name
Approved / INN / generic name
Strength
Dosage form
Visual description of the Product
Commercial Pack sizes of the product
Labeling
Information leaflet
Registration status in the country of origin and other countries
Proposed shelf life and storage conditions
Particulars of the manufacturer(s) and activity
Technical information
Composition of the product
Suitability of the product as a dietary supplement
Raw material specifications
Details of the procedures involved in the various stages of manufacture
Summarised specifications of the final product
Specifications of the packaging material
Stability data of the product
Safety requirements for borderline products

Need for the Document
Food/Dietary/Nutritional supplement or Nutraceuticals means a product other than tobacco intended to supplement the diet and include all of the following characteristics:

Contains concentrated source of one or more of the following: vitamins, minerals, amino acids, essential oils, natural substances of plants or animal origin, enzymes, substances with nutritional or physiological functions or contains any combination of these
Is intended to be taken orally in the form of tablet, capsule, powder, soft gel, granules or liquids
Is not a presented for use as a conventional food or as a sole item of a meal of the diet
Is labeled as a food supplement and has NO medical claims on it


Information which might help
When the applicant fails to submit written responses to queries within 6 months from the date of their issuance, it will be deemed that the applicant has withdrawn the application or if the queries have been reissued for a second time and the applicant provides unsatisfactory responses, the product will be disqualified and the application will be rejected. The applicant will be required to apply afresh.

Others
The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.

The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons.

The Board aims to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy and quality for all drugs, chemical substances and medical devices, locally manufactured, imported, exported, distributed, sold, or used, to ensure the protection of the consumer as envisaged by the laws regulating drugs in force in Kenya.

Functions of Pharmacy and Poisons Board

Product Registration
Pharmacy Practice
Manufacturing Services
Inspectorate

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