Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture. MENA countries are accepting international GMP inspections/certificates from leading health authorities and agencies. However, few of them still require a separate company registration that can apply to both the Marketing Authorization Holder (MAH) and the manufacturing site.
What are the company registration requirements in key countries and the challenges faced across MENA to complete this critical step towards product approval?
Overview of company registration requirements in the MENA region
North Africa, Egypt, Lebanon and Iran
North African countries, such as Egypt, Lebanon and Iran, do not require a separate company registration for the manufacturing site or the MAH. However, these MENA countries will still ask for key documents related to the manufacturing sites involved in the drug product manufacturing and batch release sites during the product registration procedure. Those documents will include:
- Country specific application forms
- Legalized manufacturing licenses
- Legalized GMP certificates
- List of products manufactured by the manufacturing site
- Site Master File
- R&D activities overview
Company part review will take place simultaneously with the product registration review with no impact on the overall registration procedure timelines.
Saudi Arabia, UAE, Oman, Kuwait, Bahrain, Qatar, Jordan and Iraq
This cluster of Middle Eastern countries will require a separate company submission with a specific company registration file, including more or less similar requirements to what is listed above. While Saudi Arabia, Kuwait and Qatar are still accepting parallel submission of both company and product files, the remaining countries (UAE, Oman, Bahrain, Jordan and Iraq) require complete company registration before submitting the product files. This can be penalizing from a timeline point of view – when the company registration step can take up to 2 years in some countries like Iraq. Companies may want to initiate the soonest possible company registration procedure in those countries to plan product approval timelines and launch activities correctly.
The Saudi Food and Drug Authority (SFDA) used to ask for a GMP site inspection for all manufacturing sites to be registered in Saudi Arabia. Currently, SFDA is becoming more flexible in accepting EU and US accredited sites, granting them a waiver from the need to conduct a physical site inspection. Iraq also requires a site inspection for manufacturing sites that do not hold EU or US GMP certification. The remaining countries rely on international certificates with very rare cases requiring site inspection, such as Biological registration in Jordan, where the Jordanian Food and Drug Authority (JFDA) can ask to visit the API manufacturing site for GMP compliance.
Another challenge to add here is the need to pay considerable registration fees and cover the auditors’ site inspection expenses (travel, accommodation, food) in countries like Saudi Arabia and Iraq. A financial assessment shall consider these costs when planning any new launch – to ensure its profitability and feasibility.
GCC centralized procedure: company registration requirements
The Centralized Procedure through Gulf Central Committee for Drug Registration procedure (GCC-DR) will require a separate company registration and site inspection by Gulf auditors. The advantage of this registration and inspection is that it will be valid for the 7 Gulf states (Saudi Arabia, UAE, Kuwait, Oman, Qatar, Bahrain and Yemen). After obtaining the centralized approval, the applicant will still need to obtain a local registration approval certificate based on the submission of the centralized approval and local fees for company registration will still need to be paid.
Below are the GCC company registration requirements. These are applicable for the MAH:
- Company Profile & Activities: a brief description of the company, the owners (in case of a private company), and the year it has been licensed.
- A number of manufacturing facilities owned by the company and the facilities’ addresses.
- The company’s relationship with all of the manufacturing sites and scope of legal and commercial responsibility (if applicable).
- Legalized Certificate proving the commercial relationship with one of the sub-distributors in the GCC states.
- Legalized GMP Certificate.
- Legalized Manufacturing License from the country of origin, mentioning the production lines.
- Organizational Chart, mentioning the different departments and the number of employees in each; Include the qualifications of the production managers, the person responsible for quality assurance, research and development manager, and the responsible pharmacist.
- Simplified Flowcharts of the different buildings and the production lines.
- List of products manufactured by the company for the products owned by the site and the products manufactured by contract manufacturing or under license, with the registration date and the marketing date in the country of origin and other countries.
- Letter from the company certifying that the products to be exported to GCC have the same composition as those marketed in the country of origin.
- List from the company indicating the countries where the company is registered and the copies of approval certificates.
- Undertaking a Letter from the company to commit to what is outlined in the Gulf medical marketing code.
- List of products the company intends to market in the GCC.
- Detailed Site Master File.
- The letter indicating the production lines the company wishes to register.
- The complete file for the first product the company wishes to register.
- Company Registration Form published on GCC-DR website
In case the manufacturer is different from the MAH, below are the requirements that should be submitted for the manufacturer (which is the case of contract manufacturing):
- Letter defining major manufacturing steps, along with the production area corresponding to each step.
- Copy of the technical agreement between the grantor of the contract and the contractor, including the following:
- Commitment from the grantor of a contract to audit production areas, control, storage, manufacturing methods, analysis, batch records, and technical facilities.
- Responsibilities of the grantor of contract and the contractor concerning manufacturing steps; while mentioning the party responsible for the final batch release.
- The Responsible Person for batch release name, position & signature with the commitment to notify the GCC with the new person’s name in case of replacement.
- Time Validity of the contract.
- Declaration from the grantor of contract certifying its responsibility for the quality of the product.
- Commitment from the Technical Manager of the grantor of a contract to inform GCC about any change in the information mentioned in points 1 and 2.
- List of countries where the product is registered and marketed (with the date of marketing) and copies of the marketing authorizations.
- Contract manufacturing should not be exclusive to GCC countries unless a local company is doing the contract manufacturing.
- Manufacturing License and GMP Certificate of the contractor (a contract manufacturer).
- GMP Inspection visit will be scheduled to inspect the contractor facilities.
A site inspection can be a highly complex step requiring the alignment of all auditors on a specific date. All production lines in the scope of the registration shall be active during the site visit. An inspection report will be communicated to the manufacturing sites within 4 weeks after the inspection date. Deficiencies shall be addressed on time by submitting a list of all corrective actions. A second visit might be required in few cases.
Company registration and inspection is an essential step of the registration procedure for several key MENA authorities. Extensive proactive planning is recommended to avoid product registration delays and proper budget forecasting. In addition, a good understanding of local requirements is crucial to prevent file rejections and delays in the review.
Many companies might miss this prerequisite to product registration. Thus, it is vital to be familiar and prepared to comply with these regional company registration requirements in MENA to ensure smooth and timely market access.
If you wish to get more information on this or other Regulatory affairs topics related to the MENA region, contact us!