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How to Register Herbal and Complementary Medicine in Kenya. To register herbal and complementary medicine, the applicant has to contact the Pharmacy and Poisons Board offices.
Examples of complementary medicine include: Alternative health approaches such as traditional Chinese medicine, homeopathy, and naturopathy. Mind and body practices like acupuncture, massage therapy, and tai chi. Natural products like herbs, dietary supplements, and probiotics.
Products made from botanicals, or plants, that are used to treat diseases or to maintain health are called herbal products, botanical products, or phytomedicines. A product made from plants and used solely for internal use is called an herbal supplement.
Procedure on how to Register Herbal and Complementary Medicine in Kenya
- Applicants are requested to carefully read the guidelines to submission of applications, 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 they can be found under the “Required Documents” section of this page or on the guidelines to submission.
- Payment of appropriate fees should be made and that can be found under the “Fees” section of this page or at guidelines to submission 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 for marketing authorization of herbal and complementary products.
- Fast-tracked registration (Locally manufactured and Priority Medicines 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 a committee on drug registration.
- Evaluation of new applications
- Complete new applications will be processed within 6 months of receipt of the application.
Required Documents to Register Herbal and Complementary Medicine in Kenya
- One duly filled application form and an electronic copy in MS Word on a CD-ROM including their supporting documents – see Annex I
- Three (3) samples of the smallest commercial pack(s) from one batch with batch certificates of analysis.
- An original Certificate of Pharmaceutical Product (WHO Format) on official papers of the issuing competent drug regulatory authority.
- A site master file in case the product is manufactured at a plant(s) not inspected and approved by PPB.
- Non refundable application fee for registration of medicines in Kenya and GMP inspection fees for facilities not yet inspected by PPB.
Office Locations & Contacts
- The Registrar
- Pharmacy and Poisons Board
Lenana Road Opp. DOD
P.O. Box 27663 00506
+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
General Enquiries: email@example.com
Pharmacy Questions: firstname.lastname@example.org
Report a Medicine Problem: email@example.com
Eligibility to Register Herbal and Complementary Medicine in Kenya
The application for the registration of herbal and complementary products can only be made by:
- The License/patent holder
- The manufacturer
- An authorized Local Technical Representative (LTR) of the manufacturer or License/patent holder
- 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 – Nil
- Application for renewal of registration of herbal and complementary products:
- Products imported into Kenya – US$ 500
- Locally manufactured in Kenya – US$ 300
The registration of herbal and complementary products is valid for five (5) 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 should also give reasons for terminating registration of a product.
Documents to Use
Application Form For Registration Of Herbal And Complementary Medicine
The Board will implement the following timelines in processing applications for marketing authorization of herbal and complementary products.
Fast-tracked registration (Locally manufactured and Priority Medicines 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 a committee on drug registration.
Evaluation of new applications
Complete new applications will be processed within 6 months of receipt of the application.
Instructions to Register Herbal and Complementary Medicine in Kenya
All applications and supporting documents should be in English and legible. Where material is not originally in English, 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 will not be accepted.
Every applicant who is not resident in Kenya should appoint ONE local technical representative who must be a company incorporated in Kenya and authorized by PPB to deal in herbal and complementary products and must hold a wholesale dealers License.
Evidence should be made by submitting a power of attorney that complies with Kenyan laws. The local technical representative should be responsible for facilitating communication with the applicant and when the product is registered he should assume all legal responsibilities regarding the product on the Kenyan market.
If the new application is from a new manufacturing site, PPB will conduct inspection of the site or use other means to verify whether the facility complies with current Good Manufacturing Practices Regulations before a product is registered. No product should be registered unless the plant complies with cGMP.
Inspection of a facility for the purposes of considering applications for renewal of registration should be done and if the facility is found not to comply with cGMP, registration of all products manufactured by the facility shall be withdrawn.
Required Information to Register Herbal and Complementary Medicine in Kenya
- Particulars of the applicant
- Name of the applicant, physical address, telephone, fax and email
- Name of the local technical representative (for imported products only), physical address, telephone, fax and email
- Particulars of the product
- Product name of the product
- Dosage form and strength of the product
- Therapeutic use(s) of the product
- Visual description of the product
- Type of container of the product
- Pack size(s) of the product
- Proposed shelf life (in months) of the product
- Storage conditions of the product
- Country of origin of the product
- Status of registration of the product in the country of origin, authorization/registration number
- Particulars of the manufacturer
- Name of the manufacturer, physical address of the manufacturing site, telephone, fax and email
- GMP status of the manufacturing site
- Composition of the product
- List all active ingredient(s) used
- List all non active ingredient(s) used
- Quality control of raw materials
- Botanical identification of the Plant used
- Botanical name
- Brief description of the living plant
- Macroscopic identification
- Microscopic identification
- Geographical source of the plant used
- Harvesting of the plant
- Stage of plant during harvesting
- Time of harvesting
- Season of harvesting
- Method of drying
- Storage of plant materials
- Evaluation of plant materials
- Purity Tests to include likely adulterants e.g. soil, pesticides, radioactive contamination, microbiological limits, animal droppings, other plant parts, heavy metals etc
- Qualitative and quantitative tests of the plant materials
- Stability studies of the finished product
- Pharmacological and toxicological information
- Safety of the product
- Ethno-medical information (literature search)
- Toxicity studies
- Pharmacological information of the product
- Efficacy studies of the product
- Dosage regimen
- Adverse/side effects
- Contraindications, warning and precautions
- Declaration by an applicant
Need for the Document
Registering herbal and complementary medicine will ensure that only good quality, safe and efficacious herbal and complementary products are available in Kenya.
This guideline presents a common format for presentation of a well-structured application for registration of herbal/complementary medicines to be submitted to Pharmacy and Poisons Board.