New Decree-law to Make the UAE a reliable global hub for pharmaceutical and medical industries
The UAE government issued a federal decree-law regarding medical products, the pharmacy profession, and pharmaceutical establishments.
This decree forms a comprehensive legislative framework that regulates the following:
- Medical and pharmaceutical products
- Pharmaceutical establishments
- Biobanks
- Pharmacy practitioners.
It does also ensure the achievement of the state’s goals.
Those goals aim to make the UAE a reliable global hub for the pharmaceutical and medical industries
Besides enhancing drug security and achieving efficient national management according to the best global standards.
Medical Products Included in the New Decree-law in Pharmaceutical and Medical Industries:
- Pharmaceutical products
- Medical devices
- Pharmaceutical products
- Healthcare products
- Biological products
- Dietary supplements
- Cosmetics
- Genetically modified products for medical use
- Chemical precursors
- Controlled, semi-controlled, hazardous, and toxic substances, whether for human or veterinary use
Pharmaceutical Establishments:
All biobanks and pharmaceutical establishments in the country are subject to the decree-law’s provisions.
As well as those operating in free zones, including:
- Public pharmacies and pharmacy chains, compounding pharmacies, medical warehouses and stores
- Manufacturing and contract manufacturing companies for medical products
- Marketing offices, pharmaceutical consultancy offices and pharmaceutical laboratories
- Contract research and development companies
- Non-clinical and clinical research entities
- Bioequivalence centers
- Any other pharmaceutical establishments as decided by the Cabinet.
Pharmacy Practitioners:
The decree-law also covers pharmacy practitioners working in the country, including those in free zones.
It regulates all provisions related to licensing, supervising, and monitoring pharmaceutical establishments and biobanks in the country.
Including provisions for transferring or relinquishing ownership to others and cases warranting temporary suspension of licenses.
In addition to precautionary closure, or license cancellation, and defines the powers of the UAE Drug Authority, the Ministry of Health and Prevention, and health authorities.
For the first time, the decree-law regulates the establishment and management of national databases for medical products, pharmaceutical establishments, and biobanks in the country.
It also specifies violations and disciplinary penalties.
Besides regulating the mechanism of the disciplinary committees’ work in the UAE Drug Authority, the Ministry of Health and Prevention.
As well as relevant local health authorities responsible for handling violations committed by establishments.
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Disciplinary penalties for violations committed by pharmaceutical establishments and biobanks include:
- Written warnings
- Written reprimands
- Fines ranging from AED 1,000 to AED 1 million
- Temporary suspension of licenses for up to 6 months
- License cancellation
For violations committed by pharmacy practitioners, penalties include:
- Written warnings
- Written reprimands
- Fines ranging from AED 1,000 to AED 500,000
- Temporary suspension of practice licenses for up to one year
- License cancellation
The decree-law grants individuals and establishments subject to its provisions a grace period of up to one year from the date it comes into effect to comply, extendable by a Cabinet decision.
