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We are excited to share the latest edition of the Law Update, beautifully and appropriately titled “Sustainable Horizons: The Saudi Arabian Vision.” Giving special honor to the Kingdom’s 2030 vision, this update focuses on a collection of both informative and inspiring articles.
For those in construction, you can learn about how the tendering environment impacts risk-pricing for contractors, the updates on the legal framework of the construction industry and how contractors can protect themselves against financial difficulties.
There is good news too from the kingdom’s banking sector, from which the practice of “Open Banking” is being pushed for! But what is open banking? We’re answering that too.
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Khaled Saqqaf - Partner, Head of Office - Jordan - Corporate / Mergers and Acquisitions / Banking and Finance / Capital Markets
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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