Marketing, Manufacturing, Packaging & Labeling Advertising
STA / Saudi Arabia
The key facts about marketing, manufacturing, packaging & labeling, advertising in Saudi Arabia. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 119.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The MAA of the pharmaceutical product will be subjected to the followings processes:
- Submit the application form and pay the fees.
- Upload the product file; The components of the file shall follow the requirements and guidelines published on the SFDA website.
- Validation The product file will be validated on a technical and business basis to ensure the applicant fulfils the requirement.
- Testing 1. The registration request will be forwarded to the SFDA Central Laboratories. 2. If more information or clarification is required, an electronic inquiry will be posted through the SDR system.
- Pricing: The Pricing Department will review the product’s price according to the “SFDA’s pricing rule.
2. What is the authorization process for the marketing of generic versions of these products?
Saudi Arabia’s generic drug market is supported by the government’s encouragement of generic substitution as a means to control costs thereby acting as a significant growth driver of this trend.
3. What are the typical fees for marketing approval?
Please see Question 4 in the Regulatory, reimbursement and pricing overview.
4. What is the period of authorization and the renewal process?
An applicant shall submit a renewal request every five years. It is possible to request renewal within six months of the certificate expiry.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The role of the Pharmacovigilance advisory committee is to provide advice on the safety of medicinal products and the investigation of adverse reactions, to enable effective risk identification, assessment and management, in the pre-and post-authorization phase leading to recommendations on the action at the request of the SFDA for products available in Saudi Arabia.
Detailed Description of the Pharmacovigilance System to Be Included in the Marketing Authorisation Application Proof of the Services of a QPPV and the Necessary Means to Notify Adverse Reactions, to be Included in the Marketing Authorisation Application. The MAH should ensure that they have an appropriate system of pharmacovigilance in place to assure responsibility for their products on the market and to ensure that appropriate action can be taken, when necessary.
6. Are foreign marketing authorizations recognized?
No, foreign marketing authorizations are not recognized.
7. Is parallel import of medicines or devices allowed?
It is illegal to import drugs or medical materials that are ban in Saudi Arabia or internationally. It is illegal to import drugs in Article (4) of the Drugs and Narcotics Control Law (found at the website of the Saudi Food and Drug Authority.
Request to import prescription drugs must be filed with the branch of the Saudi Food and Drug Authority at the port of entry to which the drugs will arrive.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
- It is not permissible for the healthcare practitioner, whether in the public or private sector to accept or give bribes, including accepting gifts that are linked to the number of prescriptions that he/she prescribes or the number of equipment he/she advises his/her patients to have; that is then reflected as a benefit to the corporate interest.
- It is not permissible for the healthcare practitioner to accept gifts, loans, equipment, instruments, or cash paid directly to him/her personally from the commercial companies for whatever justification.
- The healthcare practitioner can accept inexpensive gifts like pens and the like, such as books, or medical journals if they were presented to him/her in a non-personal way, on the condition that it is not linked to any advertisement for a specific product.
- The healthcare companies or institutions for which the healthcare practitioner works can accept educational grants and financial support to attend training courses, conferences, or other activities that these companies or institutions choose for the healthcare practitioners according to the public interests.
- On a personal basis, the healthcare practitioner is not allowed to accept subsidies to compensate his/her travel expenses, accommodation, or meals when attending symposia and conferences, or compensation on the time he/she spent to attend the training. He/she can accept the meals offered to all participants.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The Pharmaceuticals Law sets out the requirements for the manufacture of medicines. Without a license ordained by the Ministry of Health, no one is allowed to open such a factory.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product in Saudi Arabia. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made in Saudi Arabia. WHO has established detailed guidelines for good manufacturing practices. Many countries have formulated their requirements for GMP based on WHO GMP.
11. What is the inspection regime for manufacturing facilities?
The Ministry of Health and Prevention offers inspection to ensure compliance with GMPs as a business service – an applicant may file a request for an inspection of a pharmaceutical manufacturing establishment. This service is part of a quality assurance system that ensures the quality of pharmaceutical and medical products by controlling all activities associated with Good Storage Practices and Good Clinical Practices.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes, manufacturing facilities are open for inspection by foreign or third-party inspectors.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The Saudi Food and Drug Authority (SFDA), the requirements for storage, packaging, handling and transportation of medicines and devices, including the following:
- The instruments for measuring the temperature and humidity of storage areas (including vehicles used for transportation) are now required to be electronic, to allow both monitoring and the adjustment of values according to instructions provided by the medical device manufacturer.
- Temperature mapping instruments must be capable of connecting to the electronic systems used by the SFDA.
- The SFDA has provided a list of eligible facilities that provide temperature and humidity management and tracking services.
- For most devices, Medical Device Marketing Authorization (MDMA) approval from the SFDA is required before placing a product on the market.
14. What information must be included in medicine and device labeling?
Medical devices are subject to specific labelling guidelines. The device or the packaging, as appropriate, must be labelled with the name of the device, name and address of the manufacturer, special storage conditions, warnings and contra-indications, and batch code or lot number, along with many other requirements specific to the type of device. Complete labelling guidelines are available from the Medical Device department at the Saudi Food and Drug Authority.
15. What additional information may be included in labeling and packaging?
Concerning the medicines, the Code provides that the labelling and packaging of pharmaceutical products should include, among other things, the following:
- Trade name and a generic name.
- Name and address of the company/agent responsible for marketing.
- Usage, dosage and method of use.
16. What items may not be included in labeling and packaging?
Goods bearing immodest or nude pictures or bearing a cross and pictures not consistent with Islamic morals are prohibited. There should be no Koranic or Islamic sayings written on packages, other than straight translations of product contents, when necessary. If human figures are shown on packages, they should be in good taste. Photographs or illustrations of pigs or wrappings simulating pigskin should be avoided. Permission must be obtained for goods to bear the Saudi Arabian emblem, which consists of crossed swords and a palm.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
As per the Rules, the following are some of the restrictions and controls applicable to the advertisement of non-prescriptive pharmaceutical products to the general public:
- Only non-prescriptive products can be advertised.
- The product should be registered with the SFDA.
- Advertisements should only be made during the validity of the respective approval. The validity of approval for advertising products is one year.
- Advertisements should comply with the principles of Sharia and should not violate public decency.
- Advertisements should not provide incorrect or misleading information, or information that is unclear and that is susceptible to inappropriate interpretation.
Article 41 of the Interim Regulations provides for restrictions applicable to the advertising of medical devices as follows:
- The advertising of a medical device for which the SFDA has not issued a marketing authorisation is prohibited.
- All advertisement material must be approved by the SFDA.
- The advertising material must not mislead the user regarding the performance of the medical device as specified by the manufacturer.
- The advertising to the general public, including on the internet, must avoid misleading laypersons.
- Any advertising to persons qualified to use medical devices must include the relevant information compatible with their specific needs.
- Medical sales representatives must have sufficient knowledge to be able to provide appropriate information about the medical devices they promote.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Prescription-only medicine (POM) refers to a medicinal product that is subject to the Saudi Food and Drug Authority’s (SFDA) authorisation and is only available to patients in Saudi Arabia based on a licensed physician’s prescription. Places, where patients/consumers can purchase or gain access to medicinal products (pharmacies and hospitals), are authorised to distribute POMs to consumers.
Over-the-counter (OTC) products
An OTC product is a medicinal product subject to SFDA authority that can be obtained by patients in Saudi Arabia without a physician’s prescription. OTC products are distributed in pharmacies. Further, some pharmaceutical products are permitted by the SFDA to be sold in food retail stores in cities (including medium-sized grocery stores, large grocery stores and supermarkets) and highways that have the proper storage conditions and requirements for pharmaceutical products 24/7 and are allowed to sell pharmaceutical products individually.
Certain medicines such as prescription-only medicines, are only available to patients in Saudi Arabia based on a licensed physician’s prescription and therefore cannot be offered through distance selling or via post.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
Pharmaceutical products can be advertised via social media or television. Pharmaceutical companies and health care providers must ensure that the information provided to consumers is accurate, balanced, true and conforms with the promotional standards (Saudi Code of Pharmaceutical Promotional Practices).
The Rules provide that online advertisements for non-prescriptive pharmaceutical products should be available on the webpage provided by the applicant, and should not redirect visitors to other websites. It is further provided that online advertisements should not include information about medical practitioners. Concerning the medical devices, Interim Regulations provide that the advertising and marketing material must avoid misleading laypersons, when advertising to the general public, including advertisements on the internet.
20. May medicines and devices be advertised or sold directly to consumers?
Yes, it is possible to sell or advertise medicines and devices directly to consumers. Direct-to-Consumer Advertising (DTCA) of pharmaceuticals, defined as “any presentation or promotion of the information of the prescribed medications in media to the general population” has gained increasing attention over the past two decades, enhancing consumer access to prescription drug information.
21. How is compliance monitored?
Please refer to Question 8 of Regulatory, pricing and reimbursement overview.
22. What are the potential penalties for noncompliance?
Please refer to Question 9 of Regulatory, pricing and reimbursement overview.