Kenya - Obtain License to Produce, Export or Import Controlled Substances (Industrial Chemicals, Pesticides, Fertilizers and Drugs)

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Procedure

Manufacturing of controlled substances.

No person shall manufacture for sale a controlled substance unless the person has a valid licence issued by the Authority.

An application for a licence to produce or manufacture a controlled substance should be made to the Authority in the prescribed Form 1 and accompanied by the prescribed fee.

Upon the application for a licence, the Authority may grant the licence unconditionally, impose conditions on the licence or refuse to grant the licence.

Application for Export.

No person should export a controlled substance unless such person has a valid licence issued by the Authority.

An application to export a controlled substance shall be made to the Authority in the prescribed Form 4 set out and shall be accompanied by:

• a Prior Informed Consent issued by the competent Authority of the importing country;
• the prescribed fee.

Importation of controlled substances.

No person should import into Kenya a controlled substance unless such person has a valid licence issued by the Authority.

The application should be in the prescribed form and the applicant shall indicate the purpose for which the controlled substance is required.

An application to import a controlled substance should be made to the Authority in the prescribed Form 2 and accompanied by the prescribed fee.

Upon the application for a licence, the Authority may grant the licence unconditionally, impose conditions on the licence or refuse to grant the licence.

A person issued with an import licence should keep a full and accurate record of such importation.

Application for controlled substances in transit.

Any person transporting through Kenya any controlled substance, that is not destined for use in Kenya should:

• apply for approval to transport such controlled substance through Kenya; and
• ensure that the controlled substance is properly packaged and transported in accordance with the Regulations and International Standards.

An application for approval to transport through Kenya a controlled substance should be made to the Authority in the prescribed Form 3 and accompanied by -

• a copy of the Prior Informed Consent issued by the competent Authority of the importing country; and
• the prescribed deposit bond which shall be refundable.

Application for permit to import or export different quantities.

Where a person licensed to import or export any controlled substance wishes to import or export the controlled substance in different quantities and at different times, the person should make an application for a permit for every importation or exportation that is to be made.

An application for a permit to import or export a controlled substance in different quantities should be in Form 5 and accompanied by the prescribed fee.

Any person issued with a permit to import or export a controlled substance should submit a copy of the permit to the custom officials at the port of entry or exit.

The customs official at the port of entry or exit shall verify that the controlled substance permitted to be imported or exported is in accordance with the conditions set out in the licence and permit.

Acknowledgement of application.

Upon the receipt of any application, the Authority then screens the application for completeness and acknowledges receipt of the application within fourteen days.

Where the application is not complete, the Authority informs the applicant and requests the applicant to furnish the Authority with additional information.

Where the application is for the importation of a controlled substance, the Authority prepares the Prior Informed Consent and submits the same to the competent authority of the exporting country.

The Authority liaises with the relevant lead agencies in determining the application and where the Authority is satisfied that the applicant meets the requirements set out, the Authority approve the application.

Where the application does not meet the requirements set out, the Authority rejects the application.

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Required Documents

• Dully-filled application form
• Payment receipt

Office Locations & Contacts

National Environment Management Authority - Head Office,
Popo Road,South C, off Mombasa Road
P.O.BOX: 67839-00200,
Nairobi.
Tel No: 020-2101370, 020-2183718, 020-2307281, 020-2103696
Mobile: 0724 253398, 0735 013046, 0723 363 010
Fax:+(254)-020-6008997
Incident line: 0786-101100 or 0741 101 100,
Email: [email protected]
Email:[email protected]
Website: NEMA Link


NEMA Licensing portal:  : Licensing Portal

Eligibility

Any person intending to produce, export or import controlled substances in Kenya.

Fees

• Application for license to produce controlled substances Kshs.15, 000
• Application to export controlled substance Kshs.7, 500
• Application for a license to import controlled substance Kshs.15, 000
• Application for a permit to import or export a controlled substance Kshs.1, 500
• Deposit bond 15% of cost, insurance and freight value (CIF) (refundable)
• Inspection of records Ksh.200.00

Validity

12 Months

Documents to Use

Application for Registration to Import Controlled Substances

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Issuance of license takes 45 days

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M". 
	

Instructions

• Apply on time (allow enough time prior to the production, importation or exportation of controlled substances).
• Provide accurate information
• Resolution Criteria: Ozone Depleting Substance quota available for importation, exportation and production.

Required Information

• Name of Applicant
• Person Authorized to Act on behalf of Applicant (Name and Title)
• Contact Person (Name and Title)
• National Identification Card /Passport No
• Contacts Persons Physical and Postal Address (Business)
• Contacts Persons Physical and Postal Address (Residential)
• Company Name
• Physical/Address
• Postal Address
• Main Business Activity
• Tell/Fax/Email contacts
• Registration Certificate No.
• PIN number

Need for the Document

NEMA developed the Environmental Management and Co-ordination (Controlled Substances) Regulations, 2007 to regulate the use of ozone depleting substances by setting standards. The Authority in collaboration with the Kenya Revenue Authoritys Customs department and Kenya Bureau of Standards are working to ensure that controlled substances are subject to standards set by the regulation on matters such as manufacturing, importation, exportation, packaging, labeling, storage, transportation and disposal.

Issuance of license to produce, export or import controlled substances

Information which might help

Environmental Management and Co-ordination (Controlled Substances) Regulations, 2007

These Regulations aim to regulate the production, trade and use of controlled substances and products; provide for a system of data collection to facilitate compliance with relevant reporting requirements under the Montreal Protocol on Substances that Deplete the Ozone Layer; promote the use of ozone friendly substances, products, equipment and technology; and ensure the elimination of substances and products that deplete the ozone layer. Ozone Depleting Substances are chemicals that destroy the stratospheric ozone layer in the atmosphere by increasing the ultra violet rays from the sun to the earths surface. Kenya is currently a consumer of ODS and therefore relies on importation and exportation of ODS. Any importer or exporter is required under these regulations to obtain an import license or export license respectively. An importer or exporter of any ODSs in piecemeal must obtain a permit for the same. It is a requirement to comply with the license and permit conditions.

Other uses of the Document/Certificate

To control impact of Ozone of depleting substances to protect the ozone layer

External Links

Import/Export/production/Transport of Ozone Depleting Substance Licence

Controlled Substance Regulations

The Montreal Protocol on Substances that Deplete the Ozone Layer

National Environment Management Authority (NEMA)

National Environment Management Authority (NEMA) Customer Service Charter

Others

The National Environment Management Authority (NEMA), is mandated by the Environment Management and Co-ordination Act (EMCA) 1999, to exercise general supervision and co-ordination over all matters relating to the environment. It is further mandated to be the principal instrument of government in the implementation of all policies relating to the environment.

The Authority serves various stakeholders and clients;

• Private Sector (Investors, Developers, Industry etc),
• Government Ministries and departments (Lead Agencies)
• Environment Management & Coordination Act Institutions (P