Updates on Cannabinoid Regulation in Algeria
SAARPE Association / Algeria
The ongoing reform of pharmaceutical regulations in Algeria has been marked on January 2020 by publication in the Official Gazette of the long-awaited Decree No 19-379 dated of 31st December 2019. This Decree has laid down procedures for specific administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including Cannabinoids).
The Decree No 19-379 was initially planned to enter into force by 5th of April 2020 according to its Article 41, but considering COVID-19 pandemic context, the Algerian Prime Minister has executed an amendment to this article to postpone the effective date to 3rd of November 2020.
The main objective of the aforementioned Decree, whose legal anchorage is Article 245 within Health Law No 18-11 dated of 2nd July 2018, is to ensure traceability and adequate control of substances and drugs with psychotropic properties from reception of the raw materials until dispensation at the pharmacy level.
Under the Decree No 19-379, outpatient prescribing of substances and drugs with psychotropic properties is limited to three (03) months and must be written on a special prescription in three copies of different colours (white, yellow and pink): – White and yellow colour copies are given by the prescribing physician to the patient; – The pink copy is to be kept by the prescribing physician for a period of two (02) years; – The yellow copy is saved by the pharmacist after dispensing the drugs; – The white copy is returned to the patient after dispensation or directly sent to the payer.
Whereas, prescription of such substances and drugs for an urgent need in public and private hospitals have to be written on a weekly order form in double white and pink copies, with respect to the endowment, and referring to a nominative statement by substance/drug (templates were attached to the Decree 19-379).
Psychotropic drugs with a restricted prescription for exclusive hospital use must be prescribed by a specialized physician (psychiatrist) at the exercise hospital, and maximum duration of prescription is limited to one (01) month. The dispensing of these drugs is reserved for hospital pharmacies, and their list should be fixed soon through Ministerial Decree.
Besides that, every prescribing physician has to record prescriptions in a register opened for this purpose, marked and initialled by the Provential Health and Population Directorate (“DSPW” – “Direction de la Santé et de la Population de Wilaya”) for those practising in the private sector, and by the health structure director for those in the public sector. Importers, manufacturers, distributors and dispensing pharmacists must also record all moves related to substances and drugs with psychotropic properties on special registers to be kept for five (05) years.
Periodic and unannounced inspections to check compliance with provisions of the Decree No 19-379 will be carried out by the National Agency for Pharmaceutical Products (“ANPP” – “Agence Nationale des Produits Pharmaceutiques”) for pharmaceutical establishments, or by inspectors affiliated to the Ministry of Health for community pharmacies and public/private health structures.
Finally, both national and provential commissions for substances and drugs with psychotropic properties have been established by the Decree No 19-379 with the purpose of assessing the risk of abuse and pharmacodependency, and proposing all necessary measures for effective control of such substances and drugs. Composition, organization and functioning of these commissions will be fixed by Ministerial Decree of the Minister of health.
