The first Law Update of 2024 is here, and our first focus of the year spotlights Healthcare and Lifesciences, a sector that is undergoing significant growth and development across the MENA region.
Our focus provides an insight into some of the most important regulatory updates across the region, such as the UAE’s groundbreaking law on the use of human genome, Kuwait’s resolution on nuclear and radioactive materials, the new regulations for healthcare services in Qatar, Egypt’s healthcare regulatory framework, and the impact of the Saudi Civil Transactions Law on the healthcare and life sciences sector … and there is so much more!
Beyond the healthcare pages our lawyers share with you multi-sector insights where you will discover articles on Dubai’s DIFC regulatory framework for startups, Bahrain’s commercial agencies law, and we also shed light on Kuwaiti civil code and the advantages of setting up a joint stock company in Saudi Arabia.Read the full edition
The healthcare and pharmaceutical industries in Jordan have been a focal point economically considering the presence of several multi-national pharmaceutical companies that are based in the country. This required the Jordanian government to establish a robust legislation environment for companies to be well regulated in order to maximise quality assurance and reduce any fraudulent activity. The governmental authority responsible for regulating the said industries are the Jordanian Food and Drug Administration (the ‘JFDA’) and in turn the Ministry of Health (the ‘MOH’).
In recent years, Jordan has emerged as a key exporter of medicine and pharmaceuticals. This demanded the relevant authorities to revisit the basis for licensing the entities in the sector in order to establish a well organised regime for the same. The New Regulation for Licensing Pharmaceutical Establishments, No. 162 for the year 2019 (‘New Regulation’) came into effect once it was issued in the Official Gazette at the end of 2019.
The transportation, possession, distribution, sale, gifting, donation, purchasing, importing, and/or using pharmaceutical products and medication in Jordan is only permitted by companies holding a duly valid licence and registration from the MOH following approval of the Minister of Health. The said licence and approval can be granted to pharmaceutical manufacturers, pharmaceutical warehouses, pharmacies, and pharmaceutical research and development companies (‘Pharmaceutical Establishments’). Additionally, it is not permitted to circulate or sell any medication or pharmaceutical products without registering the final form and obtaining an approval containing the permitted pricing of the same at the JFDA.
This article shall focus on highlighting the main requirements for registering a Pharmaceutical Establishment and obtaining an approval for the same from the competent authorities.
It is worth noting that an application to register a Pharmaceutical Establishment must be submitted by a person who possesses a university degree in pharmaceutical studies from an accredited university, and who is registered as a pharmacist at the Jordanian Pharmacist Association ( ‘JPA’) and duly licensed to practise the profession pursuant to the Pharmacy and Pharmaceuticals Law (the ‘Licensed Pharmacist’), with the exception of pharmaceutical manufacturers that have a separate licensing regime as outlined below.
Pursuant to the New Regulation, the Licensed Pharmacist must submit the application to the JFDA, with the following required documentation:
Once the application and required documentation have been submitted, a committee shall conduct an examination of the property wherein the Pharmaceutical Establishment shall be located to ensure all regulations and instructions relating to the same are met. The MOH shall obtain the following licensing fees for Pharmaceutical Establishments:
Pharmaceutical manufacturers are treated differently and have a separate licensing regime to the remaining Pharmaceutical Establishments. The application for registering a pharmaceutical manufacturer must be submitted to the JFDA with the following required documentation;
The JFDA shall review the application to ensure all requirements have been met and then conduct an examination of the property wherein the pharmaceutical manufacturer shall be located to ensure all regulations and instructions are satisfied. The committee shall then submit the documentation and the report of the examination to the Director of the JFDA within 14 working days. The Director of the JFDA then submits the documentation and a recommendation to the Minister of Health to provide the final decision within 30 working days from the date of examination.
It is worth noting that the approval to establish a pharmaceutical manufacturer shall be deemed nullified if the said pharmaceutical manufacturer has not been established within three years of obtaining the approval. The MOH shall obtain the following licensing fees for pharmaceutical manufacturer:
The licence for a Pharmaceutical Establishment may be terminated by a decision by the Minister of Health in the following cases (amongst others):
The Pharmacy and Pharmaceuticals Law also stipulates several penalties and fines, in addition to the termination of the licence.
In conclusion, Pharmaceutical Establishments, including Pharmaceutical Manufacturers, are heavily regulated in order to advance the industry and improve the production, storage, and retail of pharmaceutical products in Jordan. Additionally, notwithstanding the regulations relating to licensing Pharmaceutical Establishments, the JFDA enforces international standards in relation to the raw materials used in pharmaceuticals and the overall quality of the same in order to compete on a global scale, and in order to ensure Pharmaceutical Establishments abide by the said regulations, the JFDA has the authority to conduct scheduled inspections and issue penalties accordingly in the case of breaches.
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