Import of Pharmaceuticals into Iran

Import of Pharmaceuticals into Iran

Pharmaceuticals importation to Iran is an appealing field for many individuals looking to establish a business in this sector. In this article, we will introduce you to various aspects of drug importation, including the required documents, necessary permits, the process of registering a pharmaceutical company, and the steps involved in importing pharmaceuticals.

 

Required Documents for pharmaceuticals Importation

To legally import pharmaceuticals, you must provide a set of essential documents. Below is a list of the necessary paperwork for importing drugs:

1. List of Countries Purchasing the Imported Drugs
2. List of Drug Manufacturing Facilities with Complete Addresses
3. Agency Certificate Issued by the Ministry of Commerce
4. Drug Importation Request Form
5. Various Certifications and Approvals
6. Persian-Language Labeling
7. Product Evaluation Form
8. Exclusive Sales License for the Foreign Company’s Products in Iran
9. Certificate of Pharmaceutical Product (CPP)from the country of origin, validated by the Iranian embassy in that country
10. Drug Master File (DMF): A document submitted to the Food and Drug Organization containing details on drug manufacturing processes, related scientific articles, usage guidelines, and packaging information.
11. Drug Pricing Form

These documents are essential to ensure compliance with legal and regulatory requirements, streamline the import process, and maintain the quality and safety of pharmaceuticals entering the country. (For more information, you can click on Import Laws and Regulations)

 

Required Pharmaceutical Import Permits in Iran

To import pharmaceuticals into Iran, specific permits must be obtained from the relevant authorities. These permits ensure compliance with regulations and the safety of imported products. The required permits for drug importation in Iran include:

1. Drug Sample Approval
2. Agency Certificate
3. Invoice Number and Date
4. Copy of the Technical Manager’s License
5. Order Registration Documents
6. Proforma Invoice Signed by the Manufacturer
7. Submission of the Drug Formulation
8. Source Registration Certificate
9. Original Health Certificate
10. Product Details in Persian

 

Steps for Registering a Pharmaceutical Import Company

1. Definition of Business Scope

The company’s scope of operations must be clearly defined in its Articles of Association or official publication in the government gazette. This documentation should be submitted to the General Directorate for Drug Supervision for review and approval.

 

2. Representation or Exclusive Sales Authorization

For companies operating on a broader scale and granting representation rights, it is essential to introduce a reputable brand as its representative. Companies intending to engage in exclusive drug sales must secure the necessary license for exclusive distribution.

 

3. Appointment of a Technical Supervisor

Each pharmaceutical import company must appoint a technical supervisor who is a qualified pharmacist with the required specialized knowledge.

 

4. Compliance with the Approved Drug List

The drugs intended for import must align with the official list of approved drugs in Iran. Comprehensive details about these drugs must be documented, including:

– Generic name;

– Brand name;

– Dosage;

– Manufacturing brand;

– The company holding the manufacturing license, and

– The country of origin for the production process.

 

5. Regulatory Oversight:

All procedures must be carried out under the supervision of the General Directorate for Drug Supervision. Applications, along with the required documentation, should be submitted to this authority for processing and approval.

 

Working Conditions for the Technical Supervisor of an Importing Company

Any company intending to import pharmaceuticals must have a key figure known as the Technical Supervisor. This individual must be a licensed pharmacist with a permanent pharmacy license, Iranian citizenship, and a clean criminal record. The company’s CEO submits the technical supervisor’s details to the General Directorate of Drug Affairs, where a legal commission evaluates and approves their capability to oversee the production and importation of pharmaceuticals and biological materials.

The responsibilities of the technical supervisor can be summarized as follows:

1. Monitoring Storage Conditions: Overseeing humidity and temperature conditions in the warehouse.
2. Supervising Safety Systems: Ensuring the security systems in the warehouse are in proper working order.
3. Warehouse Operations Oversight: Supervising all storage and inventory management processes.
4. Staff Training: Providing necessary training to personnel.
5. Packaging and Quality Assurance: Monitoring packaging and ensuring drug quality aligns with DMF (Drug Master File) specifications.
6. Document Review and Approval: Reviewing and approving all documents related to registration and importation.
7. Providing Required Certifications: Issuing and verifying certificates required by the Ministry of Health.
8. Document Modification: Amending and finalizing registration and import documents for submission to the General Directorate of Drug Affairs.
9. Adherence to Storage and Distribution Standards: Ensuring compliance with GSP (Good Storage Practices) and GDP (Good Distribution Practices) for drug storage and distribution.
10. Recall System Oversight: Managing the recall process for potentially defective or returned distributed drugs.
11. Sample Retention: Maintaining adequate samples of each batch of imported drugs for at least three complete tests.
12. Record Keeping: Keeping records of annual imports, waste, and damaged products.
13. Complaint Handling: Maintaining records of complaints, follow-ups, and resolutions.
14. Retention of Official Directives: Keeping up-to-date with and retaining current circulars issued by the Ministry of Health, Treatment, and Medical Education.

 

Steps for Importing Pharmaceuticals into Iran

Before importing pharmaceuticals to Iran, it is essential to have a thorough understanding of the relevant customs laws and regulations. The process involves specific steps, and failure to follow any of them can create significant issues. Therefore, familiarizing yourself with these steps beforehand is crucial.

 

1. Identifying a Reliable Manufacturer or Supplier

Globally, numerous companies are involved in the production of pharmaceuticals. At this stage, you need to contact various companies worldwide and select a suitable one for purchasing pharmaceuticals from abroad.

 

2. Obtaining Samples and Negotiating

Once you have chosen a company, request a list of their products and samples. Evaluate the quality of the samples and verify the company’s credibility. This step is critical for making an informed decision about whether to proceed with a business relationship.

 

3. Verifying the Quality and Credibility of the Selected Company

In addition to assessing the company’s credibility during the sample evaluation phase, conduct independent research on the company.

 

4. Drafting a Legal Contract

Prepare a detailed legal contract with the chosen company. The contract should include critical elements such as payment methods, mutual obligations, delivery terms, and penalties for non-compliance. Seek assistance from a legal consultant to ensure accuracy.

 

5. Preparing a Proforma Invoice

A proforma invoice is a crucial document in the import process. It should be prepared accurately and include details such as prices, types, and quantities of the pharmaceuticals being shipped.

 

6. Securing Import Permits

Ensure you obtain all the necessary import permits to avoid any issues during customs clearance. Later sections will elaborate on the specific permits required for pharmaceutical imports.

 

7. Transferring Payment to the Selected Company

After finalizing the agreement and signing the contract, transfer the payment for the pharmaceutical shipment to the supplier. Agree on the payment method in advance to prevent any misunderstandings or delays.

 

8. Choosing the Transportation Method

If the pharmaceuticals need to be delivered urgently, consider faster methods like air transport. Based on the type of pharmaceuticals, the country of origin, and transportation costs, select the most efficient and cost-effective method. Consult experts from international logistics companies for guidance.

 

9. Estimating Costs

To determine the price of imported pharmaceuticals for resale in Iran, you need to accurately estimate all import-related costs, including transportation. This will help you set a fair price while ensuring a reasonable profit margin. (For more information, you can click Procedure of Import to Iran)

 

10. Customs Clearance and Entry into the Iranian Market

In the final stage, ensure the pharmaceuticals are cleared through customs following legal procedures. Engage a reputable pharmaceutical import company to facilitate this process and avoid complications. Once cleared, the products can enter the distribution and sales cycle. (For more information, you can click on Customs Clearance)

 

Please do not hesitate to contact our lawyers and experts in Iran Best Lawyer for importing pharmaceuticals into Iran.