pcs.sfda.gov.sa Product Classification System : Saudi Food & Drug Authority

Organization : Saudi Food & Drug Authority
Type of Facility : Product Classification System
Country: Saudi Arabia

Website : http://pcs.sfda.gov.sa/Default.En.aspx

Product Classification System :

The Drug Sector at SFDA formed up (established) this program to submit the classification applications so the pharmaceutical companies can determine whether their products are registered or not according to the pharmaceutical products classification guideline.

Related : Saudi Food & Drug Authority Medical Devices Establishment License : www.statusin.org/10096.html

This program has been established according to the Saudi Food & Drug Authority (SFDA) regulation which issued by the Royale act number (6) on the date of 25/1/1428H, and its executive guideline that issued by the Authority board number (7-7-1428) on the date of 25/7/1429H, along with the pharmaceutical products and establishments regulation which issued by the Royale act number (31) on 1/6/1425H.

Classification procedure is considered to be optional and required. Also, if the product that is classified as (under registration product), the pharmaceutical companies of those products must register their products at SFDA before marketing them.

Security and Confidentiality of Data:
All data submitted online will be protected and encrypted via the PCS security infrastructure.

Frequently Asked Questions:
What does PCS means?:
** PCS system is an electronic system that allows both companies and institutions to submit their classification applications throw it, in order to be updated the regulation structure of their products.

How can I use the PCS system?:
** The applicant can use the PCS system if he has an account (user) at the Drug Establishment National Registration (DENR), or by signing up (forming) a new account.

What is the definition of classification? What is the difference between it and the registration?:
** The definition of classification is, a conducting procedure to determine whether the products is being under the supervision of the Authority or not. This process is performed according to the product’s chemical and physical characteristics, in addition to the medical claims (if it was available).

While the registration can be defined as, the process of issuing a marketing authorization for the products that are classified as a pharmaceutical products. Those products cannot be marketed unless they are registered at the Authority.

What are the required documents to submit a classification application?:
All required documents are available on the SFDA website which can be checked directly through this link:

Is classification required?:
The classification considered for being an optional process for the pharmaceutical companies and institutions to determine (know) whether their products are under the Authority supervision and registered or not, to allow their products to be marketed.

What are the steps and requirements to submit a classification application?:
** The classification application can be submitted through the PCS system along with the attached documents that mentioned in the conditions and requirements of classification guideline.

Can any company or institution outside Saudi Arabia submit a classification application if it owns the product’s manufacturing or marketing authorization?:
** The organization (sponsorship) which submitted the application must be located inside the Kingdom and has a commercial registration with an authorization from the pharmaceutical company to market its products inside the country.

An account (user) on the PCS system can only be formed and fully responsible by the organization (sponsorship) who marketed the products inside the Kingdom. Also, the organization can form a subsidiary accounts and give them to any other organization to use the PCS system with the responsibility of marketing organization about the inputted data.

Can the products distributed to the markets after they classified?:
** The on-process registration products cannot be marketed as a pharmaceutical product (medicine- herbal- health products) unless they get registered and get a registration certificate issued by the Authority.

But at the same time, the products which are classified as Cosmetics can be excluded from the registration process and marketed with the obligation of Gulf (GCC) standards (GSO 1943). If the Cosmetics products were manufactured outside the Kingdom, a conformity certificate must be issued from the companies that are certified by SFDA.

What are the kinds of product’s classification?:
The kinds of product’s classification are:
** Pharmaceutical product (medicine- herbal- health products) which cannot be marketed unless it is registered by the Authority.
** Health (hygiene) product which cannot be marketed unless it is registered by the Authority.
** Cosmetics products can be marketed with the obligation of Gulf (GCC) standards (GSO 1943) for cosmetics, while a conformity certificate must be issued from the companies that are certified by SFDA If the Cosmetics products were manufactured outside the Kingdom.
** Any products that are not under the Drug sector supervision.
** A rejected and un-classified product.