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Production Of The Narcotic Substances And Psychotropic Substances And The Manufacture Of Related Pharmaceuticals
Drugs and psychotropic substances, with all their destructive effects on the individual and the society, also have a positive impact related to the scientific research, therapeutics and pharmaceutical industries.
In this context, the legislator authorized certain entities to produce the narcotic substances and banned the others from using it as states in Article 30 of Federal Law No. 14 of 1995 states: “Entities other than those indicated in items (1), (2), (3) and (4) of article 11 are prohibited from producing, extracting, separating or manufacturing any substance listed in Schedules 3, 5, 6, 7 and 8, annexed to this Law
Therefore, the Law has specified the entities that may be authorized to extract, separate and manufacture the narcotic substances as classified in the Article No. 11 as follows:
(1) Government bodies and recognized institutes;
(2) State or licensed hospitals, clinics and sanatoriums;
(3) Licensed chemical analysis laboratories or medical, scientific and industrial research laboratories;
(4) Licensed medicine storehouses, pharmacies and pharmaceutical factories, provided that they employ a duly responsible pharmacist licensed to practice the profession.
Article No. 30 also states that: “The entities indicated in the above-mentioned items may not engage in any of the activities stipulated in the preceding paragraph until a license thereto has been obtained from the Competent Administrative Authority. In this regard, the provisions of articles 11 (2), 12, 13, 14 and 15 of this Law shall applied”
Accordingly, as per this Article, only the aforementioned four entities can produce, manufacture, separate and extract the narcotic substances listed in Tables 3, 6, 7 and 8, after obtaining a license from the competent administrative authorities, which is determined by a decree of the Minister of Health.
This license is subject to the provisions of Articles 11, paragraph 2, 12 (13) (14) (15):
– The Applicant is not previously convicted of an offence involving crimes of money breach of honor or trust and sentenced to suspicion, vagueness, or crimes provided in the Narcotics Law unless rehabilitated; except what is provided in sections 1-2 of Article 51.
– The narcotic substances or psychotropic substances which arrive to the customs shall be delivered under a written withdrawal permit signed by the director in charge of the authorized entity for importation on the form which is prepared by the competent administrative authority.
– The narcotics should be sent in packages that are insured and marked on their cover, in addition to the name, address and identity of the addressee, the name of the narcotics and the sender’s name and full address.
As for the manufacture of pharmaceuticals in factories and pharmacies, it also requires obtaining a license from the competent administrative authority. As states in Article 31: “ In medical preparations factories or pharmacies, no preparation, the composition of which includes a narcotic drug or a psychotropic substance, may be manufactured except after the license provided for in article 17 has been obtained in accordance with the requirements specified in that article”
When the owner of the factory or pharmacy obtains the aforementioned license, he will be obliged to abide by the content of the license, ie, the narcotic substances shall only be used in the field of Pharmaceuticals as states in Article 31:”Such entities may not utilize these substances except in the manufacture of the preparations which they produce. They shall observe the provisions of articles 21 and 22 with regard to such substances received by them, and the provisions of these two articles as well as article 18, with regard to the medical preparations produced by them, the composition of which includes such substances in any concentration whatsoever”
As it is indicating from the text of the law, the licensed entity must be adhered to use narcotic substances only in the manufacture of Pharmaceuticals, and also the entity should comply with the provisions of Article 21, which requires the director of the licensed entity to prepare a register to record the received narcotic substances, the pages of this register shall be numbered and stamped by the competent administrative authority prior to the commencement of its use and to comply with the provisions of Article 22 which requires the authorized entity to send a registered letter to the competent administrative authority in the first week of each month a statement signed by the director in charge containing the incoming and outgoing Narcotic materials.
Without neglecting the commitment to the percentages listed in Table 9, as states in Article No. 32: “Pharmacies and medical preparations factories may not exceed the percentages indicated in Schedule 9 annexed to this Law and, at the same time, must observe the requirements stipulated in established pharmacopoeia”
We note from the above how the legislator worked on the codification of the production, reproducing and manufacturing of narcotic substances and medical preparations and making them a tightly sealed chain of importation to the separation and production or scientific research until they reach the patient without any gap, thus ensuring the optimal investment and only within legitimate frameworks.