Terms & conditions for the registration of Companies, Drugs, Medical Appliances, Agents and whole-sellers of drugs in Yemen

leabul1e.gif (224 bytes) Terms & conditions for the registration of the Producing Companies:

1.GMP certificate issued by an international specialized known organization approved by the Supreme Board of Drugs and Medical Appliances (SBDMA).

2.GMP certificate issued from the country of origin legalized by the health authorities and Yemen Embassy.

3.File of the manufacturing site with contents in accordance to Pharmaceutical Inspection Convention.

4.Letter of authorization from the manufacturing company.

Terms & conditions for the registration of a pharmaceutical product:

1.An application form filled by the technician in charge working for the agent, the form should be sealed and stamped with a stamp of 10 Y. Rials category and payment of the fees. (the form to be taken from the Registration Dept.).

2. Free Sale Certificate in the country of origin as per the sample of World Health Organization (WHO) legalized by the health authorities.

3. Free Sale and Composition Certificate of the pharmaceutical product containing the active and inactive ingredients including the colouring, relinquishing, and flavoring if available and specifying their quantities, this certificate should also comprise the date of registration of the product and date of start of its free sale (marketing), the pharmaceutical form, packing, composition, internal leaflet in the country of origin in the form as required to be registered in Yemen. The certificate must be legalized by the Ministry of Public Health, Ministry of Foreign Affairs, and the Yemeni Embassy or any other institution in charge of the Yemeni Embassy, and in case of non availability of both to be legalized by any Arabian Embassy.

4. Analysis Certificate of the product to evidence that the result of the analysis is in compliance with mentioning the constitutional reference sealed with the laboratory stamp and the producing company in the country of origin. (the sample to be taken from the Registration Dept.).

5.Price Certificate sealed by the company comprising the whole and retail prices at the country of origin and the proposed price CIF to one of Yemen ports.

6.Method of Analysis in case the consitutional reference was not mentioned opposite to the components in the Composition Certificate.

7.Referential standard specimen for each active ingredient in the item if other than as in the approved constitution.

8.Stability study of the pharmaceutical product.

9.Clinical study if the product was newly invented.

10.Twenty samples of the product to be registered (in packs used for sale).

11.Three internal leaflets, three external covers, and three stickers.

12.Two plastic enforced files (one containing originals of the documents and certificates + two photocopies), the second file contains a photo copy for each document and certificate.

Terms and conditions for the registration of the
Medical Appliances:

1.Free sale and sterilization certificate for the items applicable to sterilization.

2.Price Certificate sealed by the company comprising the whole and retail prices at the country of origin and the proposed price CIF to one of Yemen ports.

3. Six pieces samples for each item on which all necessary data are written.


Terms and conditions for registration of Agent/whole-seller:

1.The existence of a location approved by the SBDMA.

2.The presence of a whole-time working pharmacist not Govternmentally employed and not having private activities.

Public price structure

CIF price

+ 10% customs & clearnace

+ 10% whole sale margin

+ 20% the pharmacy profit.

= Public price.

The CIF price should include the following:

Free medical samples

Free goods

Importer commission

+ provision of medical reps.
+ promotional materials (catalogues, gifts, brochures, pamphlets) … etc.

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