Haiti - Open Pharmaceutical Agency

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Procedure

1. To open an pharmaceutical agency, you have to approach the Ministry of Public Health and Population. Some address information are provided under the Office Locations & Contacts section of this page where you could contact for help.
2. Make sure you have all the documents that are listed under the Required Documents section of this page which would be requested by authorities during the processing of the application and while submitting the application.
3. The owner who is requesting to open a Pharmaceutical agency should make the request through a letter to the Ministry of Public Health and Population.
4. You will be requested to have followed the following standards and procedures.
   • Local processing procedures
   • Hygiene standard
   • Written procedures struggles against rodents and insects
   • Drug approval procedures
   • Drug distribution procedures
   • Drug retention procedures
   • Recall procedure
   • Standards for distribution of narcotics and psychotropic
5. You will also have to pay a fees of 15,000.00 gourdes (non refundable)
6. After inspection of the premises by the inspectors of the MWD / MT, if the inspection service gives a favorable opinion, the operating authorization is granted by the DPM / MT MSPP.
   
   

You also have to meet the following standards:

• Teaches,
• Pallets and shelves for storage of medicines,
• Extinguisher,
• Wall thermometer
• Walls and ceiling painted in easily cleanable oil,
• Refrigerated room for products that must be kept cool.
• Safety devices for narcotics and psychotropic
• File review and inspection fees by certified check 15,000.00 gourdes (non refundable value)

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Required Documents

• Letter from the Chief Pharmacist
• Photocopy of Diploma Qualified Person (original to be presented)
• Photocopy of the end of their social service (original to be presented)
• Photocopy of the license of the Chief Pharmacist
• Photocopy of the recent identity card and two photos of Responsible Pharmacist of identity
• List of products that will be distributed with their active ingredients, their pharmacological properties, their shapes, their dosages
• Criminal record of Pharmacist and Owner
• Laboratory letter authorizing the agency
• CV and reference letters from the Chief Pharmacist and Owner (3 by individuals, letters from relatives or allies are not accepted)
  
  

Additional Documents for Foreign Operators

• Translated into French by a sworn and the original agent and legalized by the nearest consulate and approved by Ministry of Foreign Affairs.

Office Locations & Contacts

Following is the website which is related to Ministry of Public Health and Population which could help : Ministry of Public Health and Population

Following address information is a place where you can contact and they would provide you with guidance on the process that you have to follow and the offices that you have to approach.

Administrative Information Center (ARC)
14 rue Debussy, Turgeau,
Port-au-Prince, Hati
Tel : +509 4891-6222, +509 4892-4531
Tel : 8674
E-mail : [email protected]
Opening hours : 8.30 to 4.30 p.m

Eligibility

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Fees

Application fee study and inspection by certified check 15,000.00 gourdes (non refundable value)

Validity

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e.g. Birth Certificate Valid Forever

Documents to Use

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Sample Documents

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Processing Time

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Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M". 
	

Instructions

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e.g. The state office holds birth records since January 1908.

Required Information

• Location of the agency

Need for the Document

This procedure provides you information about how to get permission or license to open a pharmaceutical agency in Haiti. Any company that conducts the import and wholesale of medicines, vaccines and medical devices from one or more laboratories manufacturing local or foreign pharmaceuticals should get a permission or license from Ministry of Public Health and Population in Haiti.

Information which might help

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Other uses of the Document/Certificate

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e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

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