An Overview on Oman’s Pharmacy Law no. 35/2015
Objective of the Law
To regulate the practice of the pharmacy profession and pharmaceutical establishments.
Main Points of Pharmacy Law
Interpretations of some terminology mentioned in the Law
- Pharmaceutical profession:
According to the Law it means preparing, installing, manufacturing, packing, storing, importing, exporting, selling or distributing medicine.
- Pharmaceutical institutions:
It includes the following >>> Pharmacies, drug stores, drug factories, scientific offices and consulting Pharmaceuticals offices, drug analysis laboratories and any other institutions to be determined by a decision from the minister in a later stage.
- Scientific office:
A licensed place that provides technical or marketing information about medicines by all scientific means.
- Pharmaceutical Consultation Office:
A licensed place that provides consultations, research or studies related to the practice of Pharmacy profession.
License and Insurance is Required
According to article 2 of Pharmacy Law it is not allowed for anyone to practice pharmaceutical profession or work as a pharmacist’s assistant unless he/she has a license from the Ministry of Health, and he must be insured for the benefit of third parties against his/her liability (Professional Liability Insurance).
The period of the license is two years and it could be renewed for a similar period as per the same requirements for obtaining a license.
Prohibition of Practicing any other Profession
Pursuant to article 7 of Pharmacy Law, it is not permitted to combine the practice of Pharmacy profession with the medical profession or any other profession contradicting with the Pharmacy Profession.
However, Pharmacists may provide the necessary first aid in case of emergency.
Agreements with Doctors
According to article 8 of Pharmacy Law, pharmacists and doctors are not allowed to agree on the method of writing medical prescriptions, and it is also prohibited to have any financial distribution between pharmacists and doctors.
Article 11 of Pharmacy Law states, except for the pharmaceutical factories, the owner of the pharmaceutical establishment or one of his partners must be an Omani pharmacist.
If the Pharmacy owner dies, the ownership of the license passes to the heirs, provided that they adjust their status within a maximum period of (5) five years from the date of death.
Obligations of pharmaceutical warehouses, factories, and medical supplies providers
Pursuant to article 12 of Pharmacy Law, the aforementioned establishments are prohibited from the following:
A – Refraining from selling medicines or medical supplies to licensed pharmaceutical institutions or forcing the pharmacies to purchase any certain quantities, or charging a price higher than its licensed price.
b- carrying out any activity aimed at monopolizing the trading of medicines or medical supplies on its own or with others.
Managing the Pharmaceutical Entity
According to article 13, a pharmaceutical institution should have a licensed pharmacist who is responsible for the management of it. Pharmacists are not allowed to be in charge of managing more than one pharmaceutical institution.
Owner and Manager Obligation
Article 24 of Pharmacy Law provides that, the owner of the pharmaceutical establishment or its responsible manager shall immediately notify the Directorate when inventorying the pharmacy’s content, or stealing accident happened or damage to the medicines whatever the cause.
Articles 37 and 39 of Pharmacy Law stipulate that, anyone who violates the provisions of this law or its regulations, then imprisonment shall be applied for a period of not less than (1) month, and not exceeding (1) year, and a fine of not less than (100) One hundred Riyals Omani, and not exceeding (1,000) one thousand Rial Omani, or either of these two penalties.
Further, the technical committee stipulated in Article (27) of this law have the authority to consider the violations committed by pharmacists or pharmacists’ assistants or the owners of pharmaceutical establishments for the provisions of this law and its regulations.
Where, the violator has to be notified in order to personally attend before the committee and confront him with the violations and hear his statements regarding it and investigate his defense.
If a violation is proven, the committee has the right to apply one of the following penalties:
- An administrative fine of not less than (100) one hundred Riyals Omani, and not more than (1000) thousand Omani riyals.
- Suspension from practicing the profession or the closure of a pharmaceutical establishment in which the violation occurred for a period not exceeding one year.
- Cancellation of the violator’s license and a removal of his name from the register, or revocation of the institution’s license
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