Highlights of the Controlled Substances Regulations, 2007 (Legal Notice No.73 of 2007)
- The Controlled Substances Regulations defines controlled substances and provides guidance on how to handle them. This regulation mandates NEMA to monitor the activities of persons handling controlled substances, in consultation with relevant line ministries and departments, to ensure compliance with the set requirements. Under these regulations, NEMA will be publishing a list of controlled substances and the quantities of all controlled substances imported or exported within a particular. The list will also indicate all persons holding licenses to import or export controlled substances, with their annual permitted allocations.
- The regulations stipulate that controlled substances must be clearly labelled with among other words, “Controlled Substance-Not ozone friendly’’) to indicate that the substance or product is harmful to the ozone layer. Advertisement of such substances must carry the words, “Warning: Contains chemical materials or substances that deplete or have the potential to deplete the ozone layer.”
- Producers and/or importers of controlled substances are required to include a material safety data sheet. Persons are prohibited from storing, distributing, transporting or otherwise handling a controlled substance unless the controlled substance is accompanied by a material safety data sheet.
- Manufacturers, exporters or importers of controlled substances must be licensed by NEMA. Further, any person wishing to dispose of a controlled substance must be authorized by NEMA. The licensee should ensure that the controlled substance is disposed of in an environmentally sound manner. These regulations also apply to any person transporting such controlled substances through Kenya. Such a person is required to obtain a Prior Informed Consent (PIC) permit from NEMA.
- Persons handling controlled substances are required to apply for a permit from NEMA. A decision on whether a permit will be granted or not will be communicated to the applicant within 45 days of receipt of the application. The license issued is valid for one year from the date of issue and may be renewed on application. NEMA may suspend or revoke a license where the licensee has contravened any of the conditions set out in the license.
- Any licensee who imports or produces any controlled substances is required to ensure that all persons who receive or buy such substances sign a declaration form. He/she must keep copies of the declaration forms and submit them to NEMA after every six months.
- Where an imported controlled substance does not meet set specifications, NEMA shall require the licensee to return the controlled substance to the country of origin at his/her cost or pay to NEMA the cost of disposing of the controlled substance.
- Any person who contravenes the provisions of these regulations commits an offence and may, on conviction, be liable to a fine, imprisonment or both.