Product Registration

The Minister for Health in consultation with the Pharmacy and Poisons Board is empowered by section 44(1) of the Pharmacy and Poisons Act, Cap 244 and misc. Amendments of 2002 to make rules under which medicines may be imported, manufactured for sale or sold in Kenya.
PREPARATIONS LIABLE TO REGISTRATION
Products claimed to be useful for any of the following purposes:

  1. Treating or preventing a disease
  2. Alleviating symptoms of a disease
  3. Diagnosing a disease
  4. Ascertaining the existence, degree or extent of a physiological condition.
  5. Preventing or interfering with the normal operation of a physiological function whether permanently or temporarily and whether by way of terminating, reducing, postponing, increasing or accelerating the operation of that function, in human beings and animals. For example: these include substances which can be used as a contraceptive or for the purpose of inducing anesthesia.
  6. Blood, blood plasma and blood preparations containing cellular elements of blood.
  7. Surgical preparations such as catgut, plaster of Paris, bandages and artificial heart valves.

Registered Drugs

Click here to get the list of Registered Drugs in Kenya

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Important

Pharmacy Practice

The Pharmacy and Poisons Board is committed to its mission to ensure the availability of pharmaceutical services in Kenya which satisfy the needs of all for the prevention, diagnosis and treatment of diseases using safe, efficacious, high quality and cost effective pharmaceutical products.Pursuant to this mission, it is imperative that pharmaceuticals are distributed by highly qualified personnel through outlets that are duly licensed and professionally run. The operations in those premises should at all times be supervised by qualified personnel and the risk of exposing the public to unsafe medicines avoided at all cost. Guidelines have been prepared to provide persons in the pharmaceutical fraternity with a method of assessing eligibility and the process of lawfully operating drug distribution outlets.

The success of this initiative will ultimately depend on the active contribution and cooperation of every stakeholder.

Registered Practitioners and Premises

Click here to get the list of Registered Practitioners and Premises in Kenya

Download guidelines here

For new license applications download forms here…

Download the new Annual License Renewal Forms for Practitioners and Premises here …

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Licences Ready for Collection

Manufacturing Services

CONDITIONS FOR MANUFACTURER REGISTRATION

  1. The manufacturer must comply with GMP.
  2. Each foreign manufacturer shall have one local agent with blanket power of attorney.
  3. Provision of a free sale certificate from the country of origin or a certificate of a pharmaceutical product.
  4. A separate application for each product
  5. Payment of the approved fees
  6. Certificate issued is valid for a period five years

 

Who may apply for Registration

The application to register a pharmaceutical product should be made by the manufacturer. This person may either perform all the manufacturing and packaging operations by himself or assign one or more of the operations to someone else. In the later instance, however, it is necessary for the applicant to have such influence over the subject as will enable him to bear full responsibility for the relevant information that is given in the application for registration.A foreign manufacturer may be represented in Kenya by a domiciled agent who is empowered to plead the manufacturer’s cause before the Pharmacy and Poisons Board.An agent for a foreign manufacturer must file a blanket power of attorney which authorizes him to speak for his principal in all matters relating to the latter specialties.Ownership of the Certificate of Registration shall be vested with the manufacturer who is the owner of the registered product. In case of contract manufacture the contract giver will be deemed to be the owner.

The Board reserves the right to verify the Good Manufacturing Practices Compliance of the manufacturer at the applicant’s expense.

A separate application is required for each product. In this context a product means in the case of a drug or medicinal product, a dosage form in a specified strength.

The Certificate of Registration for a Pharmaceutical Product shall be valid for five years.

The application form for Good Manufacturing Practice inspection for Pharmaceutical Manufacturing Facilities is available here.

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Inspectorate

Wholesale distribution and retail forms part of the supply chain of manufactured therapeutic goods. Wholesalers are responsible for effective, efficient and safe handling, storage and distribution of such products. On the other hand retailers are the final/contact personnel with the clients/patients. As such, these guidelines set out appropriate steps for meeting these responsibilities. Current Good Distribution Practices for pharmaceutical products incorporates and provide for minimum requirements on aspects of the following:

1.1 Building and grounds
1.2 Facilities
1.3 Personnel
1.4 Stock handling and Stock control
1.5 Transport
1.6 Complaints
1.7 Documentation and records
1.8 Counterfeit products
1.9 Sale of unregistered medicines

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