The Ministry of Health has approved the modifications and addition of new clauses in the executive regulations of facilities law, pharmaceutical, and providing health care, which includes vaccines, measuring of biomarkers, health education, and training on using medical devices.

The Major Changes In The New Regulations:

The Ministry provides the license to pharmacies & electronic herbal preparations facilities, and approval to use self-vending machines.

Normal or Saudi Personnel are allowed to receive privileges or commercial agencies for a foreigner chain of pharmacies by complying with all conditions

Pharmacist to adhere to dispense prescribed drugs by its scientific name only, excluding the drug’s list issued by the competent party which must be dispensed by its commercial name

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At least 1 pharmacy should be operating for 24-hrs., for every 20 pharmacies under the same owner, considering the fair distribution of pharmacies geographically

Pharmacies are allowed to prepare specialized laboratories to prepare pharmaceuticals, following fulfillment of the licensing requirements

Pharmaceutical specialists to comply with the marketing practice ethics of pharmaceuticals, that was approved by the Saudi blog and issued by the Saudi Food and Drug Authority

Pharmacies adhere to provide all locally manufactured drugs, which is listed by the competent party in all vending outlets

Owners of pharmacies are prohibited to get any material or in-kind benefit from pharmaceutical companies, agents, distributors, or warehouse in return of providing their medicine

Pharmaceutical factories are required to provide all the technical specifications which were determined by the Saudi Food and Drug Authority

The warehouse should have an electronic system to manage materials and organize supply and distribution processes. The system should be integrated with the electronic tracking system, which was approved by the Saudi Food and Drug Authority. The System must be used to record all the transactions related to the pharmaceutical package

The owner of the pharmacy or the herbal preparation facility should submit a request to renew the provided license at least 3 months prior to the expiry date

Non-pharmacist staff are allowed to be appointed in the pharmacies and herbal preparation facilities, in order to take over the selling of non-pharmaceuticals only

Pharmacists and pharmacy technicians are allowed to be delegated between pharmacies and herbal preparation facilities under conditions

The Pharmacist should adhere to dispense electronic prescriptions of primary care centers and hospitals related to the ministry

The pharmacist to adhere to present all the options of the local and foreign drug, which are available to the patient to achieve the patient’s benefit

The warehouse to comply with the blog conditions of the good distribution and storage practice

The license duration of the pharmaceutical facility to be calculated starting from the issuing date

The warehouse owner to commit to implementing regulations and instructions issued by the Saudi Food and Drug Authority

Pharmacies to review the sales percentage of the locally manufactured drugs by the end of each financial year as per the approved mechanism

Pharmacies that have an independent license are allowed to be opened within the medical complexes

The facility will not hold any liability for the license renewal delay upon submitting the renewal request within the statutory period

The pharmaceutical facility will not be allowed to appoint pharmacists or pharmacy technicians without obtaining their license to practice

The proportion of Saudi pharmacists to the total number of pharmacists working in the pharmaceutical facilities that owned by the same owner is subject to the standards of the Ministry of Labor and Social Development in the fields of occupations by regions and governorates

Pharmacies should adhere to reporting the Saudi Food and Drug Authority about the companies that don’t provide preparations before the end of inventory at least one month in advance, depending on the consumption quantities and annual need

The functions of the pharmaceutical specialist shall be restricted to Saudi pharmacists, except for pharmacists working before the issuance of the regulation. Also, to comply with the mechanism of localization of employees in the field of advertising and introducing pharmaceutical and herbal preparations issued by the Saudi Food and Drug Authority