Regulatory Corpus, Authorities Involved, Permits & Certificates, Technical Standards, Chain of Distribution, Liabilities & Commitments

As a result of sensitivities, the legal environment of this sector, either from industrial or commercial point of view, considerably differs from other business. There is a long list of requirements to be met for being engaged in any part of this sector including manufacturing, licensing, importation (/ exportation) and distribution. The Ministry of Health, whose Food & Drugs Organisation is in charge of supervising this sector, has created a comprehensive regulatory framework and bureaucracy, thereby all activities in this sector are subject to obtaining permits and authorisations beforehand. In this sector and in addition to the general requirements applicable to the industrial or commercial activities, the relevant project / business should be registered with and confirmed by the MOH and the factory / producing lines should meet the technical requirements and the relevant license agreement / distribution agreement should comply with particular expectations (like exclusivity) and letter of commitments satisfactory to the FDO should be submitted.

We provide all legal needs to take the relevant formalities before the authorities in charge, prepare various contracts to be concluded and have clear understanding of / comply with the relevant laws and regulations.