Article 35 of the Saudi Pharmaceutical Establishments Law

This article sets the penalties for the acts counted as violations in Article 34, on two levels, without prejudice to any more severe penalty provided by another law.

First level (paragraph 1): for all the acts in Article 34, a penalty of one or more of the following:

• A fine not exceeding SAR 5,000,000.
• Temporary closure of the pharmaceutical establishment for a period not exceeding 180 days.
• Cancellation of the license.

The fine and the closure may be doubled if the violation is repeated.

Second level (paragraph 2): if the violation is one of the acts in paragraphs (1), (2), (4), (7) and (8) of Article 34, which are:

• Adulteration or attempted adulteration.
• Selling, dispensing or possessing for trade an adulterated, spoiled, expired or unregistered product.
• Bringing an unregistered, adulterated, spoiled or expired product into the Kingdom, or attempting to.
• Bringing in containers or wrappers with intent to defraud, or attempting to.
• Making, printing, possessing, selling or displaying containers or wrappers with intent to defraud.

then the penalty is imprisonment for a period not exceeding 10 years, or a fine not exceeding SAR 10,000,000, or both. In addition, temporary closure or license cancellation may be imposed.

The amounts and periods mentioned are upper limits; the text does not fix the penalty for each particular case. It is followed by Article 36, which gives the Authority power to impose fines below set amounts depending on the type of establishment.

To understand how this provision applies to a particular case, it is advisable to consult a lawyer specialized in health and pharmaceutical regulations.